Document:

EX-10.5

 Exhibit 10.5 

ENTELLUS MEDICAL, INC. 

2015 EMPLOYEE STOCK PURCHASE PLAN 

ARTICLE I. 
 PURPOSE,
SCOPE AND ADMINISTRATION OF THE PLAN 
 1.1 Purpose and Scope. The purpose of the Entellus Medical, Inc. 2015 Employee Stock
Purchase Plan (the “Plan”) is to assist employees of Entellus Medical, Inc. and its Designated Subsidiaries in acquiring a stock ownership interest in the Company pursuant to a plan which is intended to qualify as an “employee
stock purchase plan” under Section 423 of the Code and to help such employees provide for their future security and to encourage them to remain in the employment of the Company and its Subsidiaries. 

ARTICLE II. 
 DEFINITIONS

 Whenever the following terms are used in the Plan, they shall have the meaning specified below unless the context clearly indicates
to the contrary. The singular pronoun shall include the plural where the context so indicates. 
 2.1 “Agent” means the
brokerage firm, bank or other financial institution, entity or person(s), if any, engaged, retained, appointed or authorized to act as the agent of the Company or an Employee with regard to the Plan. 

2.2 “Administrator” shall mean the Committee, or such individuals to which authority to administer the Plan has been
delegated under Section 7.1 hereof. 
 2.3 “Code” shall mean the Internal Revenue Code of 1986, as amended. 

2.4 “Committee” shall mean the Compensation Committee of the Board, or another committee or subcommittee of the Board or the
Compensation Committee described in Article 7 hereof. 
 2.5 “Common Stock” shall mean shares of common stock, par value
$0.001, of the Company. 
 2.6 “Company” shall mean Entellus Medical, Inc., a Delaware corporation. 

2.7 “Compensation” of an Employee shall mean the regular straight-time earnings, base salary or quarterly or annual cash
bonus paid to the Employee from the Company or any Designated Subsidiary on each Payday as compensation for services to the Company or any Designated Subsidiary, before deduction for any salary deferral contributions made by the Employee to any tax-qualified or nonqualified deferred compensation plan of the Company or any Designated Subsidiary, including prior week adjustments, but excluding vacation pay, holiday pay, jury duty pay, funeral leave pay,
military pay, overtime, commissions, incentive compensation, one-time bonuses (e.g., retention or sign-on bonuses), fringe benefits, education or tuition reimbursements, imputed income arising under any Company or Designated Subsidiary group
insurance or benefit program, travel expenses, business and moving reimbursements, 

  
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income received in connection with any stock options, stock appreciation rights, restricted stock, restricted stock units or other compensatory equity awards and all contributions made by the
Company or any Designated Subsidiary for the Employee’s benefit under any employee benefit plan now or hereafter established. Such Compensation shall be calculated before deduction of any income or employment tax withholdings, but shall be
withheld from the Employee’s net income. 
 2.8 “Designated Subsidiary” shall mean the Subsidiaries that have been
designated by the Board from time to time in its sole discretion as eligible to participate in the Plan, including any Subsidiary in existence on the Effective Date and any Subsidiary formed or acquired following the Effective Date, in accordance
with Section 7.2 hereof. 
 2.9 “Effective Date” shall mean the date on which the Company’s registration
statement relating to its initial public offering becomes effective, provided that the Board has adopted the Plan prior to or on such date, subject to approval of the Plan by the Company’s stockholders. 

2.10 “Eligible Employee” means an Employee of the Company or any Designated Subsidiary who does not, immediately after an
Option is granted, own (directly or through attribution) stock possessing five percent or more of the total combined voting power or value of all classes of Stock or other stock of the Company, a Parent or Subsidiary (as determined under
Section 423(b)(3) of the Code). For purposes of the foregoing, the rules of Section 424(d) of the Code with regard to the attribution of stock ownership shall apply in determining the stock ownership of an individual, and stock which an
Employee may purchase under outstanding options shall be treated as stock owned by the Employee. Notwithstanding the foregoing, the Committee may determine in its discretion, and if so determined, shall set forth in the terms of the applicable
Offering, that an Employee of the Company or any Designated Subsidiary shall not be eligible to participate in such Offering if: (a) such Employee has been in the employ of the Company or any Designated Subsidiary for less than two years (or
any shorter period); (b) such Employee’s customary employment with the Company or any Designated Subsidiary is twenty (20) hours or less per week and/or not more than five (5) months per calendar year (or any lesser number of
hours per week or months per calendar year); (c) such Employee is a “highly compensated employee” of the Company or any Designated Subsidiary (within the meaning of Code Section 414(q)), or is such a “highly compensated
employee” (i) with compensation above a specified level, (ii) who is an officer and/or (iii) is subject to the disclosure requirements of Section 16(a) of the Exchange Act; and/or (d) such employee is a citizen or
resident of a foreign jurisdiction and the grant of an Option under the Plan or Offering is prohibited under the laws of such foreign jurisdiction, or compliance with the laws of such foreign jurisdiction would cause the Plan or Offering to violate
the requirements of Code Section 423; provided, that any exclusion in clauses (a), (b), (c) and (d) shall be applied in an identical manner under each Offering to all employees of the Company and all Designated Subsidiaries, in
accordance with Treasury Regulation Section 1.423-2(e). 
 2.11 “Employee” shall mean any person who renders services
to the Company or a Designated Subsidiary in the status of an employee within the meaning of Section 3401(c) of the Code. “Employee” shall not include any director of the Company or a Designated Subsidiary who does not render services
to the Company or a Designated Subsidiary in the status of an 

  
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employee within the meaning of Section 3401(c) of the Code. For purposes of the Plan, the employment relationship shall be treated as continuing intact while the individual is on military
leave, sick leave or other leave of absence approved by the Company or Designated Subsidiary and meeting the requirements of Treasury Regulation Section 1.421-1(h)(2). Where the period of leave exceeds three (3) months, or such other
period specified in Treasury Regulation Section 1.421-1(h)(2), and the individual’s right to reemployment is not guaranteed either by statute or by contract, the employment relationship shall be deemed to have terminated on the first day
immediately following such three (3)-month period, or such other period specified in Treasury Regulation Section 1.421-1(h)(2). 

2.12 “Enrollment Date” shall mean the first date of each Offering Period. 

2.13 “Exercise Date” shall mean the last Trading Day of each Offering Period, except as provided in Section 5.2 hereof.

 2.14 “Exchange Act” shall mean the Securities Exchange Act of 1934, as amended. 

2.15 “Fair Market Value” shall mean, as of any date, the value of a share of Common Stock determined as follows: 

(a) If the Common Stock is (i) listed on any established securities exchange (such as the New York Stock Exchange, the NASDAQ Capital
Market, the NASDAQ Global Market and the NASDAQ Global Select Market), (ii) listed on any national market system or (iii) listed, quoted or traded on any automated quotation system, its Fair Market Value shall be the closing sales price
for a Share as quoted on such exchange or system for such date or, if there is no closing sales price for a Share on the date in question, the closing sales price for a Share on the last preceding date for which such quotation exists, as reported in
The Wall Street Journal or such other source as the Administrator deems reliable; 
 (b) If the Common Stock is not listed on an
established securities exchange, national market system or automated quotation system, but the Common Stock is regularly quoted by a recognized securities dealer, its Fair Market Value shall be the mean of the high bid and low asked prices for such
date or, if there are no high bid and low asked prices for a Share on such date, the high bid and low asked prices for a Share on the last preceding date for which such information exists, as reported in The Wall Street Journal or such other
source as the Administrator deems reliable; or 
 (c) If the Common Stock is neither listed on an established securities exchange, national
market system or automated quotation system nor regularly quoted by a recognized securities dealer, its Fair Market Value shall be established by the Administrator in good faith. 

2.16 “Grant Date” shall mean the first Trading Day of an Offering Period. 

2.17 “New Exercise Date” shall have such meaning as set forth in Section 5.2(b) hereof. 

  
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 2.18 “Offering” shall mean each distinct offering of Options made under this
Plan, within the meaning of Treasury Regulation 1.423-2(a). 
 2.19 “Offering Period” shall mean the period, which shall be
set by the Committee, with respect to which Options are granted to Participants under an Offering; provided, that the duration of any Offering Period can be no more than twenty-seven months. 

2.20 “Option” shall mean the right to purchase shares of Common Stock pursuant to the Plan during each Offering. 

2.21 “Option Price” shall mean the purchase price of a share of Common Stock hereunder as provided in Section 4.2
hereof. 
 2.22 “Parent” means any entity that is a parent corporation of the Company within the meaning of
Section 424 of the Code and the Treasury Regulations thereunder. 
 2.23 “Participant” shall mean any Eligible
Employee who elects to participate in the Plan. 
 2.24 “Payday” shall mean the regular and recurring established day for
payment of Compensation to an Employee of the Company or any Designated Subsidiary. 
 2.25 “Plan” shall mean this Entellus
Medical, Inc. 2015 Employee Stock Purchase Plan, as it may be amended from time to time. 
 2.26 “Plan Account” shall mean
a bookkeeping account established and maintained by the Company in the name of each Participant. 
 2.27 “Section 423
Option” shall have such meaning as set forth in Section 3.1(b) hereof. 
 2.28 “Subsidiary” shall mean any
entity that is a subsidiary corporation of the Company within the meaning of Section 424 of the Code and the Treasury Regulations thereunder. In addition, with respect to any sub-plans adopted under Section 7.1(d) hereof which are designed
to be outside the scope of Section 423 of the Code, “Subsidiary” shall include any corporate or noncorporate entity in which the Company has a direct or indirect equity interest or significant business relationship. 

2.29 “Trading Day” shall mean a day on which the principal securities exchange on which the Common Stock is listed is open
for trading or, if the Common Stock is not listed on a securities exchange, shall mean a business day, as determined by the Administrator in good faith. 

2.30 “Withdrawal Election” shall have such meaning as set forth in Section 6.1(a) hereof. 

  
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 ARTICLE III. 

PARTICIPATION 
 3.1
Eligibility. 
 (a) Any Eligible Employee who shall be employed by the Company or a Designated Subsidiary on a given Enrollment Date
for an Offering shall be eligible to participate in the Plan during the applicable Offering Period, subject to the requirements of Articles IV and V hereof, and the limitations imposed by Section 423(b) of the Code and the Treasury Regulations
thereunder. 
 (b) No Eligible Employee shall be granted an Option under the Plan which permits the Participant’s rights to purchase
shares of Common Stock under the Plan, and to purchase stock under all other employee stock purchase plans of the Company, any Parent or any Subsidiary subject to Section 423 of the Code (any such Option or other option, a “Section 423
Option”), to accrue at a rate which exceeds $25,000 of fair market value of such stock (determined at the time the Section 423 Option is granted) for each calendar year in which any Section 423 Option granted to the Participant is
outstanding at any time. For purposes of the limitation imposed by this subsection, 
 (i) the right to purchase stock under
a Section 423 Option accrues when the Section 423 Option (or any portion thereof) first becomes exercisable during the calendar year; 

(ii) the right to purchase stock under a Section 423 Option accrues at the rate provided in the Section 423 Option,
but in no case may such rate exceed $25,000 of fair market value of such stock (determined at the time such option is granted) for any one calendar year; and 

(iii) a right to purchase stock which has accrued under a Section 423 Option may not be carried over to any other
Section 423 Option; provided that Participants may carry forward amounts so accrued that represent a fractional share of stock and were withheld but not applied towards the purchase of Common Stock under an earlier Offering, and may apply such
amounts towards the purchase of additional shares of Common Stock under a subsequent Offering. 
 The limitation under this Section 3.1(b) shall be
applied in accordance with Section 423(b)(8) of the Code and the Treasury Regulations thereunder. 
 3.2 Election to Participate;
Payroll Deductions 
 (a) Except as provided in Section 3.3 hereof, an Eligible Employee may become a Participant in the Plan only
by means of payroll deduction. Each individual who is an Eligible Employee as of the Enrollment Date of the applicable Offering may elect to participate in such Offering and the Plan by delivering to the Company a payroll deduction authorization no
later than the tenth (10th) calendar day prior to the applicable Enrollment Date. 

  
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 (b) Subject to Section 3.1(b) hereof, payroll deductions with respect to an Offering
(i) shall be equal to at least one percent (1%) of the Participant’s Compensation as of each Payday during the applicable Offering Period, but not more than twenty percent (20%) of the Participant’s Compensation as of each
Payday during the applicable Offering Period and (ii) may be expressed either as (A) a whole number percentage or (B) a fixed dollar amount. Amounts deducted from a Participant’s Compensation with respect to an Offering Period
pursuant to this Section 3.2 shall be deducted each Payday through payroll deduction and credited to the Participant’s Plan Account. 

(c) Following at least one (1) payroll deduction, a Participant may decrease (to as low as one percent (1%)) the amount deducted
from such Participant’s Compensation during an Offering Period upon ten (10) calendar days’ prior written or electronic notice to the Company; provided, however, that a Participant may not decrease the amount deducted more than two
(2) times per Offering. A Participant may not increase the amount deducted from such Participant’s Compensation during an Offering. 

(d) Notwithstanding the foregoing, upon the termination of an Offering, each Participant in such Offering shall automatically participate in
the immediately following Offering at the same payroll deduction percentage as in effect at the termination of the prior Offering, unless such Participant delivers to the Company a different election with respect to the successive Offering in
accordance with Section 3.1(a) hereof, or unless such Participant becomes ineligible for participation in the Plan. 
 3.3 Leave of
Absence. During leaves of absence approved by the Company meeting the requirements of Treasury Regulation Section 1.421-1(h)(2) under the Code, an individual shall be treated as an Employee of the Company or Designated Subsidiary that
employs such individual immediately prior to such leave. 
 ARTICLE IV. 

PURCHASE OF SHARES 
 4.1
Grant of Option. Each Participant shall be granted an Option with respect to an Offering on the applicable Grant Date. Subject to the limitations of Section 3.1(b) hereof, the number of shares of Common Stock subject to a
Participant’s Option shall be determined by dividing (a) such Participant’s payroll deductions accumulated prior to the applicable Exercise Date and retained in the Participant’s Plan Account on such Exercise Date by (b) the
applicable Option Price; provided that in no event shall a Participant be permitted to purchase with respect to each Offering more than 2,000 shares of Common Stock (subject to any adjustment pursuant to Section 5.2 hereof, but not the reverse
stock split effectuated on January 7, 2015). The Administrator may, for future Offerings, increase or decrease, in its absolute discretion, the maximum number of shares of Common Stock that a Participant may purchase during such future
Offerings. Each Option shall expire on the Exercise Date for the applicable Offering immediately after the automatic exercise of the Option in accordance with Section 4.3 hereof, unless such Option terminates earlier in accordance with Article
6 hereof. 
 4.2 Option Price. The Option Price per share of Common Stock to be paid by a Participant upon exercise of the
Participant’s Option on the applicable Exercise Date for an 

  
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Offering shall be equal to 85% of the lesser of the Fair Market Value of a share of Common Stock on (a) the applicable Grant Date and (b) the applicable Exercise Date; provided that in
no event shall the Option Price per share of Common Stock be less than the par value per share of the Common Stock. 
 4.3 Purchase of
Shares. 
 (a) On the applicable Exercise Date for an Offering, each Participant shall automatically and without any action on such
Participant’s part be deemed to have exercised his or her Option to purchase at the applicable Option Price the largest number of whole shares of Common Stock which can be purchased with the amount in the Participant’s Plan Account,
subject to Sections 4.1 and 5.3 hereof. The balance, if any, remaining in the Participant’s Plan Account (after exercise of such Participant’s Option) as of such Exercise Date shall be carried forward to the next Offering, unless the
Participant has elected to withdraw from the Plan pursuant to Section 6.1 hereof or, pursuant to Section 6.2 hereof, such Participant has ceased to be an Eligible Employee. 

(b) As soon as practicable following the applicable Exercise Date, the number of shares of Common Stock purchased by such Participant
pursuant to Section 4.3(a) hereof shall be delivered (either in share certificate or book entry form), in the Company’s sole discretion, to either (i) the Participant or (ii) an account established in the Participant’s name
at a stock brokerage or other financial services firm designated by the Company. If the Company is required to obtain from any commission or agency authority to issue any such shares of Common Stock, the Company shall seek to obtain such authority.
Inability of the Company to obtain from any such commission or agency authority which counsel for the Company deems necessary for the lawful issuance of any such shares shall relieve the Company from liability to any Participant except to refund to
the Participant such Participant’s Plan Account balance, without interest thereon. 
 4.4 Transferability of Rights. An Option
granted under the Plan shall not be transferable, other than by will or the applicable laws of descent and distribution, and shall be exercisable during the Participant’s lifetime only by the Participant. No Option or interest or right to the
Option shall be available to pay off any debts, contracts or engagements of the Participant or his or her successors in interest or shall be subject to disposition by pledge, encumbrance, assignment or any other means whether such disposition be
voluntary or involuntary or by operation of law by judgment, levy, attachment, garnishment or any other legal or equitable proceedings (including bankruptcy), and any attempt at disposition of the Option shall have no effect. 

ARTICLE V. 
 PROVISIONS
RELATING TO COMMON STOCK 
 5.1 Common Stock Reserved. Subject to adjustment as provided in Section 5.2 hereof, the maximum
number of shares of Common Stock that shall be made available for sale under the Plan (following the reverse stock split effectuated on January 7, 2015) shall be the sum of (a) 200,000 and (b) an annual increase on the first day of
each calendar year beginning in 

  
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2016 and ending in 2025, equal to the lesser of (i) one percent (1%) of the shares of Common Stock and Common Stock outstanding on the date of adoption of the Plan and (ii) such
smaller number of shares of Common Stock as may be determined by the Board. Shares of Common Stock made available for sale under the Plan may be authorized but unissued shares, treasury shares of Common Stock or reacquired shares reserved for
issuance under the Plan. 
 5.2 Adjustments Upon Changes in Capitalization, Dissolution, Liquidation, Merger or Asset Sale. 

(a) Changes in Capitalization. Subject to any required action by the stockholders of the Company, the number of shares of Common Stock
which have been authorized for issuance under the Plan but not yet placed under an Option, as well as the price per share and the number of shares of Common Stock covered by each Option under the Plan which has not yet been exercised shall be
proportionately adjusted for any increase or decrease in the number of issued shares of Common Stock resulting from a stock split, reverse stock split, stock dividend, combination or reclassification of the Common Stock or any other increase or
decrease in the number of shares of Common Stock effected without receipt of consideration by the Company; provided, however, that conversion of any convertible securities of the Company shall not be deemed to have been “effected without
receipt of consideration.” Such adjustment shall be made by the Administrator, whose determination in that respect shall be final, binding and conclusive. Except as expressly provided herein, no issuance by the Company of shares of stock of any
class, or securities convertible into shares of stock of any class, shall affect, and no adjustment by reason thereof shall be made with respect to, the number or price of shares of Common Stock subject to an Option. 

(b) Dissolution or Liquidation. In the event of the proposed dissolution or liquidation of the Company, the Offering then in progress
shall be shortened by setting a new Exercise Date (the “New Exercise Date”), and shall terminate immediately prior to the consummation of such proposed dissolution or liquidation, unless provided otherwise by the Administrator. The
New Exercise Date shall be before the date of the Company’s proposed dissolution or liquidation. The Administrator shall notify each Participant in writing, at least ten (10) business days prior to the New Exercise Date, that the Exercise
Date for the Participant’s Option has been changed to the New Exercise Date and that the Participant’s Option shall be exercised automatically on the New Exercise Date, unless prior to such date the Participant has withdrawn from the
Offering as provided in Section 6.1(a)(i) hereof or the Participant has ceased to be an Eligible Employee as provided in Section 6.2 hereof. 

(c) Merger or Asset Sale. In the event of a proposed sale of all or substantially all of the assets of the Company, or the merger of
the Company with or into another corporation, each outstanding Option shall be assumed or an equivalent Option substituted by the successor corporation or a Parent or Subsidiary of the successor corporation. In the event that the successor
corporation refuses to assume or substitute for the Option, any Offerings then in progress shall be shortened by setting a New Exercise Date and any Offering Periods then in progress shall end on the New Exercise Date. The New Exercise Date shall be
before the date of the Company’s proposed sale or merger. The Administrator shall notify each Participant in writing, at least ten (10) business days prior to the New Exercise Date, that the Exercise Date for the Participant’s Option
has been changed to the New Exercise Date and that the Participant’s 

  
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Option shall be exercised automatically on the New Exercise Date, unless prior to such date the Participant has withdrawn from the Offerings as provided in Section 6.1(a)(i) hereof or the
Participant has ceased to be an Eligible Employee as provided in Section 6.2 hereof. 
 5.3 Insufficient Shares. If the
Administrator determines that, on a given Exercise Date, the number of shares of Common Stock with respect to which Options are to be exercised may exceed the number of shares of Common Stock remaining available for sale under the Plan on such
Exercise Date, the Administrator shall make a pro rata allocation of the shares of Common Stock available for issuance on such Exercise Date in as uniform a manner as shall be practicable and as it shall determine in its sole discretion to be
equitable among all Participants exercising Options to purchase Common Stock on such Exercise Date, and unless additional shares are authorized for issuance under the Plan, no further Offerings shall take place and the Plan shall terminate pursuant
to Section 7.5 hereof. If an Offering is so terminated, then the balance of the amount credited to the Participant’s Plan Account which has not been applied to the purchase of shares of Common Stock shall be paid to such Participant in one
(1) lump sum in a subsequent payroll check as soon as practicable after such Exercise Date, without any interest thereon. 
 5.4
Rights as Stockholders. With respect to shares of Common Stock subject to an Option, a Participant shall not be deemed to be a stockholder of the Company and shall not have any of the rights or privileges of a stockholder. A Participant shall
have the rights and privileges of a stockholder of the Company when, but not until, shares of Common Stock have been deposited in the designated brokerage account following exercise of his or her Option. 

ARTICLE VI. 
 TERMINATION
OF PARTICIPATION 
 6.1 Cessation of Contributions; Voluntary Withdrawal. 

(a) A Participant may cease payroll deductions during an Offering and elect to withdraw from the Plan by delivering written or electronic
notice of such election (a “Withdrawal Election”) to the Company in such form as may be established by the Administrator and within seven (7) days prior to the Exercise Date for such Offering (or such other period of time as
may be established by the Administrator). A Participant electing to withdraw from the Plan may elect to either (i) withdraw all of the funds then credited to the Participant’s Plan Account as of the date on which the Withdrawal Election is
received by the Company, in which case amounts credited to such Plan Account shall be returned to the Participant in one (1) lump-sum payment in cash within thirty (30) days after such election is received by the Company, without any
interest thereon, and the Participant shall cease to participate in the Plan and the Participant’s Option for such Offering shall terminate; or (ii) exercise the Option for the maximum number of whole shares of Common Stock on the
applicable Exercise Date with any remaining Plan Account balance returned to the Participant in one (1) lump-sum payment in cash within thirty (30) days after such Exercise Date, without any interest thereon, and after such exercise cease
to participate in the Plan. As soon as practicable receipt of a notice of withdrawal from the Plan, the Participant’s payroll deduction authorization and his or her Option to purchase shares of Common Stock under the Plan shall terminate. 

  
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 (b) A Participant’s withdrawal from the Plan shall not have any effect upon his or her
eligibility to participate in any similar plan which may hereafter be adopted by the Company or in succeeding Offerings which commence after the termination of the Offerings from which the Participant withdraws. 

(c) A Participant who ceases contributions to the Plan during any Offerings shall not be permitted to resume contributions to the Plan during
such Offering. 
 6.2 Termination of Eligibility. Upon a Participant’s ceasing to be an Eligible Employee, for any reason, such
Participant’s Option for the applicable Offering shall automatically terminate, he or she shall be deemed to have elected to withdraw from the Plan, and such Participant’s Plan Account shall be paid to such Participant or, in the case of
his or her death, to the person or persons entitled thereto as set forth in an applicable beneficiary designation form (or, if there is no such applicable form, pursuant to applicable law), within thirty (30) days after such cessation of being
an Eligible Employee, without any interest thereon. 
 ARTICLE VII. 

GENERAL PROVISIONS 
 7.1
Administration. 
 (a) The Plan shall be administered by the Committee (or another committee or a subcommittee of the Board assuming
the functions of the Committee under the Plan), which, unless otherwise determined by the Board, shall consist solely of two or more members of the Board, each of whom is intended to qualify as a “non-employee director” as defined by Rule
16b-3 of the Exchange Act and an “independent director” under the rules of any securities exchange or automated quotation system on which the shares of Common Stock are listed, quoted or traded, in each case, to the extent required under
such provision. The Committee may delegate administrative tasks under the Plan to the services of an Agent and/or Employees to assist in the administration of the Plan, including establishing and maintaining an individual securities account under
the Plan for each Participant. 
 (b) It shall be the duty of the Administrator to conduct the general administration of the Plan in
accordance with the provisions of the Plan. The Administrator shall have the power, subject to, and within the limitations of, the express provisions of the Plan: 

(i) To establish and terminate Offerings and Offering Periods; 

(ii) To determine when and how Options shall be granted and the provisions and terms of each Offering (which need not be
identical); 
 (iii) To select Designated Subsidiaries in accordance with Section 7.2 hereof; and 

(iv) To construe and interpret the Plan, the terms of any Offering and the terms of the Options and to adopt such rules for
the administration, interpretation, and application of the Plan as are consistent therewith and to interpret, amend or revoke any such rules. The Administrator, in the exercise of this power, may 

  
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correct any defect, omission or inconsistency in the Plan, any Offering or any Option, in a manner and to the extent it shall deem necessary or expedient to make the Plan fully effective, subject
to Section 423 of the Code and the Treasury Regulations thereunder. 
 (c) The Administrator may adopt rules or procedures relating to
the operation and administration of the Plan to accommodate the specific requirements of local laws and procedures. Without limiting the generality of the foregoing, the Administrator is specifically authorized to adopt rules and procedures
regarding handling of participation elections, payroll deductions, payment of interest, conversion of local currency, payroll tax, withholding procedures and handling of stock certificates which vary with local requirements. In its absolute
discretion, the Board may at any time and from time to time exercise any and all rights and duties of the Administrator under the Plan. 

(d) The Administrator may adopt sub-plans applicable to particular Designated Subsidiaries or locations, which sub-plans may be designed to
be outside the scope of Section 423 of the Code. The rules of such sub-plans may take precedence over other provisions of this Plan, with the exception of Section 5.1 hereof, but unless otherwise superseded by the terms of such sub-plan,
the provisions of this Plan shall govern the operation of such sub-plan. 
 (e) All expenses and liabilities incurred by the Administrator
in connection with the administration of the Plan shall be borne by the Company. The Administrator may, with the approval of the Committee, employ attorneys, consultants, accountants, appraisers, brokers or other persons. The Administrator, the
Company and its officers and directors shall be entitled to rely upon the advice, opinions or valuations of any such persons. All actions taken and all interpretations and determinations made by the Administrator in good faith shall be final and
binding upon all Participants, the Company and all other interested persons. No member of the Board or Administrator shall be personally liable for any action, determination or interpretation made in good faith with respect to the Plan or the
options, and all members of the Board or Administrator shall be fully protected by the Company in respect to any such action, determination or interpretation. 

7.2 Designation of Subsidiary Corporations. The Board or Committee shall designate from among the Subsidiaries, as determined from time
to time, the Subsidiary or Subsidiaries that shall constitute Designated Subsidiaries. The Board or Committee may designate a Subsidiary, or terminate the designation of a Subsidiary, without the approval of the stockholders of the Company. 

7.3 Reports. Individual accounts shall be maintained for each Participant in the Plan. The Company shall provide each Participant whose
Option is exercised with an information statement in accordance with Code Section 6039(a) and the regulations promulgated thereunder. The Company shall maintain a procedure for identifying certificates of shares of Stock sold upon the exercise
of Options in accordance with Code Section 6039(b). 
 7.4 No Right to Employment. Nothing in the Plan shall be construed to
give any person (including any Participant) the right to remain in the employ of the Company, a Parent or a Subsidiary or to affect the right of the Company, any Parent or any Subsidiary to terminate the employment of any person (including any
Participant) at any time, with or without cause, which right is expressly reserved. 

  
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 7.5 Amendment, Suspension and Termination of the Plan 

(a) The Board may, in its sole discretion, amend, suspend or terminate the Plan at any time and from time to time; provided, however, that
without approval of the Company’s stockholders given within twelve (12) months before or after action by the Board, the Plan may not be amended to increase the maximum number of shares of Common Stock subject to the Plan; and provided
further that without approval of the Company’s stockholders, the Plan may not be amended in any manner that would cause the Plan to no longer be an “employee stock purchase plan” within the meaning of Section 423(b) of the Code
(including without limitation extension of the term of the Plan). No Option may be granted during any period of suspension of the Plan or after termination of the Plan. Without stockholder consent and without regard to whether any Participant rights
may be considered to have been “adversely affected,” the Board or the Committee, as applicable, shall be entitled to change the terms of the Offering, limit the frequency and/or number of changes in the amount withheld during an Offering,
establish the exchange ratio applicable to amounts withheld in a currency other than U.S. dollars, permit payroll withholding in excess of the amount designated by a Participant in order to adjust for delays or mistakes in the Company’s
processing of properly completed withholding elections, establish reasonable waiting and adjustment periods and/or accounting and crediting procedures to ensure that amounts applied toward the purchase of Common Stock for each Participant properly
correspond with amounts withheld from the Participant’s Compensation, and establish such other limitations or procedures as the Board or the Committee, as applicable, determines in its sole discretion advisable which are consistent with the
Plan and Code Section 423. 
 (b) In the event the Administrator determines that the ongoing operation of the Plan may result in
unfavorable financial accounting consequences, the Administrator may, to the extent permitted under Section 423 of the Code, in its discretion and, to the extent necessary or desirable, modify or amend the Plan to reduce or eliminate such
accounting consequence including, but not limited to: 
 (i) Altering the Option Price for any Offering including an
Offering underway at the time of the change in Option Price; 
 (ii) Shortening any Offering so that the Offering Period
ends on a new Exercise Date, including an Offering underway at the time of the Administrator action; and 
 (iii) Allocating
shares of Common Stock. 
 Such modifications or amendments shall not require stockholder approval or the consent of any Participant. 

(c) Upon termination of the Plan, the balance in each Participant’s Plan Account shall be refunded as soon as practicable after such
termination, without any interest thereon. 

  
 12 

 7.6 Use of Funds; No Interest Paid. All funds received by the Company by reason of
purchase of Common Stock under the Plan shall be included in the general funds of the Company free of any trust or other restriction and may be used for any corporate purpose. No interest shall be paid to any Participant or credited under the Plan.

 7.7 Term; Approval by Stockholders. The Plan shall be submitted for the approval of the Company’s stockholders within twelve
(12) months after the date of the Board’s initial adoption of the Plan. Options may be granted prior to such stockholder approval; provided, however, that such Options shall not be exercisable prior to the time when the Plan is approved by
the stockholders; provided further that if such approval has not been obtained by the end of said twelve (12)-month period, all Options previously granted under the Plan shall thereupon terminate and be canceled and become null and void without
being exercised. The Plan shall terminate on the tenth (10th) anniversary of the date of its initial approval by the stockholders of the Company, unless earlier terminated in accordance with
Sections 5.3 or 7.5 hereof or unless the Company’s stockholders do not approve the Plan in accordance with this Section 7.7. 

7.8 Effect Upon Other Plans. The adoption of the Plan shall not affect any other compensation or incentive plans in effect for the
Company, any Parent or any Subsidiary. Nothing in the Plan shall be construed to limit the right of the Company, any Parent or any Subsidiary (a) to establish any other forms of incentives or compensation for Employees of the Company or any
Parent or any Subsidiary or (b) to grant or assume Options otherwise than under the Plan in connection with any proper corporate purpose, including, but not by way of limitation, the grant or assumption of options in connection with the
acquisition, by purchase, lease, merger, consolidation or otherwise, of the business, stock or assets of any corporation, firm or association. 

7.9 Conformity to Securities Laws. Notwithstanding any other provision of the Plan, the Plan and the participation in the Plan by any
individual who is then subject to Section 16 of the Exchange Act shall be subject to any additional limitations set forth in any applicable exemption rule under Section 16 of the Exchange Act (including any amendment to Rule 16b-3 of the Exchange Act) that are requirements for the application of such exemptive rule. To the extent permitted by applicable law, the Plan shall be deemed amended to the extent necessary to conform to such
applicable exemptive rule. 
 7.10 Notice of Disposition of Shares. Each Participant shall give the Company prompt notice of any
disposition or other transfer of any shares of Common Stock acquired pursuant to the exercise of an Option if such disposition or transfer is made (a) within two (2) years after the applicable Grant Date or (b) within one
(1) year after the transfer of such shares of Common Stock to such Participant upon exercise of such Option. The Company may direct that any certificates evidencing shares acquired pursuant to the Plan refer to such requirement. 

7.11 Tax Withholding. The Company or any Parent or any Subsidiary shall be entitled to require payment in cash or deduction from other
compensation payable to each Participant of any sums required by federal, state or local tax law to be withheld with respect to any purchase of shares of Common Stock under the Plan or any sale of such shares. 

  
 13 

 7.12 Governing Law. The Plan and all rights and obligations thereunder shall be construed
and enforced in accordance with the laws of the State of Delaware. 
 7.13 Notices. All notices or other communications by a
Participant to the Company under or in connection with the Plan shall be deemed to have been duly given when received in the form specified by the Company at the location, or by the person, designated by the Company for the receipt thereof
(including without limitation the Company’s stock plan administrator). 
 7.14 Conditions To Issuance of Shares. 

(a) Notwithstanding anything herein to the contrary, the Company shall not be required to issue or deliver any certificates or make any book
entries evidencing shares of Common Stock pursuant to the exercise of an Option by a Participant, unless and until the Board or the Committee has determined, with advice of counsel, that the issuance of such shares of Common Stock is in compliance
with all applicable laws, regulations of governmental authorities and, if applicable, the requirements of any securities exchange or automated quotation system on which the shares of Common Stock are listed or traded, and the shares of Common Stock
are covered by an effective registration statement or applicable exemption from registration. In addition to the terms and conditions provided herein, the Board or the Committee may require that a Participant make such reasonable covenants,
agreements, and representations as the Board or the Committee, in its discretion, deems advisable in order to comply with any such laws, regulations or requirements. 

(b) All certificates for shares of Common Stock delivered pursuant to the Plan and all shares of Common Stock issued pursuant to book entry
procedures are subject to any stop-transfer orders and other restrictions as the Committee deems necessary or advisable to comply with federal, state or foreign securities or other laws, rules and regulations and the rules of any securities exchange
or automated quotation system on which the shares of Common Stock are listed, quoted or traded. The Committee may place legends on any certificate or book entry evidencing shares of Common Stock to reference restrictions applicable to the shares of
Common Stock. 
 (c) The Committee shall have the right to require any Participant to comply with any timing or other restrictions with
respect to the settlement, distribution or exercise of any Option, including a window-period limitation, as may be imposed in the sole discretion of the Committee. 

(d) Notwithstanding any other provision of the Plan, unless otherwise determined by the Committee or required by any applicable law, rule or
regulation, the Company may, in lieu of delivering to any Participant certificates evidencing shares of Common Stock issued in connection with any Option, record the issuance of shares of Common Stock in the books of the Company (or, as applicable,
its transfer agent or stock plan administrator). 
 7.15 Equal Rights and Privileges. Except with respect to sub-plans designed to be
outside the scope of Section 423 of the Code, all Eligible Employees of the Company (or of any Designated Subsidiary) shall have equal rights and privileges under this Plan to the extent 

  
 14 

 
required under Section 423 of the Code or the regulations promulgated thereunder so that this Plan qualifies as an “employee stock purchase plan” within the meaning of
Section 423 of the Code or the Treasury Regulations thereunder. Any provision of this Plan that is inconsistent with Section 423 of the Code or the Treasury Regulations thereunder shall, without further act or amendment by the Company or
the Board, be reformed to comply with the equal rights and privileges requirement of Section 423 of the Code or the Treasury Regulations thereunder. 

* * * * * * 
 I hereby
certify that the foregoing Entellus Medical, Inc. Employee Stock Purchase Plan was duly approved by the Board of Directors of Entellus Medical, Inc. on December 22, 2014. 

I hereby certify that the foregoing Entellus Medical, Inc. Employee Stock Purchase Plan was duly approved by the stockholders of Entellus
Medical, Inc. on January 9, 2015. 
 Executed on this 13th day of January, 2015. 

 

	
	 /s/ Thomas E. Griffin

	Thomas E. Griffin
	Chief Financial Officer

  
 15EX-10.7

 Exhibit 10.7 

[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED WITH RESPECT TO THE OMITTED PORTION. 
 CONFIDENTIAL SETTLEMENT AGREEMENT AND NON-EXCLUSIVE PATENT 

LICENSE AGREEMENT 
 This
Confidential Settlement Agreement and Non-Exclusive Patent license Agreement (“Agreement”), effective as of this 17 day of February, 2011 (“Effective Date”), by and between the following parties: 

a) Acclarent, Inc., a corporation organized under the laws of the State of Delaware, having its principal office at 1525-B O’Brien
Drive Menlo Park, CA 94025 (“Acclarent”); and 
 b) Entellus Medical, Inc., a corporation organized under the laws of the
State of Delaware, having its principal office at 6705 Wedgwood Court North, Maple Grove, MN 55311 (“Entellus”). 
 ARTICLE
1—BACKGROUND 
 1.1 Acclarent asserts that Entellus’ currently marketed FinESS and XprESS products each infringe one or more
of issued U.S. Patent Nos. 7,740,642; 7,645,272; 7,654,997; 7,717,933; and 7,753,929 covering instruments and methods for treating sinus disorders, which are owned by Acclarent. 

1.2 Acclarent filed an action against Entellus in the U.S. District Court for the Northern District of California on July 28, 2010
alleging such infringement (“Infringement Case”). 
 1.3 Entellus denies the allegations in the Infringement Case and has asserted
that the Patents-in-Suit are not infringed, are invalid, and are unenforceable. 
 1.4 The parties wish to resolve their dispute and the
pending litigation under the terms and conditions of this Agreement. 
 Therefore, in consideration of the mutual promises contained in this
Agreement, the parties agree as follows: 
 ARTICLE 2—DEFINITIONS 

The following terms, when used with initial capital letters, shall have the meanings set forth below. 

 2.1 “Affiliate” is any entity that directly or indirectly controls, is controlled by,
or is under common control with either party, and for such purpose “control” shall mean the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of the entity, whether through the
ownership of voting securities, by contract or otherwise. 
 2.2 “Calendar Quarter” is the usual and customary calendar quarter,
used for internal accounting purposes, of approximately three (3) months, in which each of the first two months consist of four weeks and the third month consists of five weeks. 

2.3 “Covered Products” are the products specifically identified in Appendix A to this Agreement, and any future products
embodying [***]. 
 2.4 “Field” is the expansion of paranasal sinuses and sinus pathways. 

2.5 “Licensed Patents” are U.S. Patent Nos. 7,740,642; 7,645,272; 7,654,997; 7,717,933; and 7,753,929 (the “Asserted
Patents”). Licensed Patents shall also include any other counterparts of the Asserted Patents worldwide, as well as all continuations, continuations-in-part, divisions, renewals, reissues, and
reexaminations of the Asserted Patents, and any other patent that has or will issue from any patent application that claims or lends any form of priority to the Asserted Patents, the practice of which is reasonably necessary for Entellus to make,
have made, use, sell, offer to sell, import or otherwise dispose of a Covered Product. Furthermore, Licensed Patents shall also include each patent which Acclarent owns or is empowered to grant a license to Entellus prior to or during the term of
this Agreement, the practice of which is reasonably necessary for Entellus to make, have made, use, sell, offer to sell, import or otherwise dispose of a Covered Product. 

2.6 “Net Sales” is the revenue that Entellus or its Affiliates actually collect from the sale of Covered Products to an unaffiliated
third party, less the following amounts: (i) discounts, including cash discounts, or rebates actually allowed or granted, (ii) credits or allowances actually granted upon claims or returns regardless of the party requesting the
return, (iii) freight charges paid for delivery, and (iv) taxes or other governmental charges levied on or measured by the invoiced amount whether absorbed by the billing or the billed party. In the event that [***] (“Staple
Products”), then Net Sales shall be calculated based on the net selling price of [***]. Further, Net Sales shall include any Staple Product that is [***]. 

2.7 “Regulatory Approval” is the clearance from a regulatory agency, such as those granted by the FDA under a 510(k) submission or a
PMA submission, or any substantially equivalent foreign government clearance, to market and sell a Covered Product. 

  
 [***] CERTAIN INFORMATION IN THIS
DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION. 

  
 - 2 - 

 2. 8 “Royalty Generating Patents” are any patent of the Licensed Patents that generates
a royalty obligation for Entellus to pay under this Agreement. 
 2.9 “Valid Claim” is a bona fide, unexpired issued claim in the
Licensed Patents that has not been held invalid or unenforceable by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and that has not been admitted to be
invalid by Acclarent or its successors or assigns through reissue or disclaimer. 
 ARTICLE 3—TERM 

3.1 Unless otherwise terminated in accordance with the provisions of Article 14 herein, the term of this Agreement shall be from the Effective
Date until the date upon which the last of the Licensed Patents expires or is abandoned. 
 ARTICLE 4—SETTLEMENT 

4.1 The parties agree to dismiss the Infringement Case and all claims and counterclaims asserted therein. The parties shall execute the
Stipulations attached hereto as Appendix C and shall file the executed Stipulations with the appropriate district court following execution of this Agreement. Each party shall [***], and shall execute any such other documents as may be
necessary to secure the dismissal with prejudice as set forth in the applicable Stipulations. 
 ARTICLE 5—LICENSE GRANT

 5.1 Subject to the terms and conditions of this Agreement, Acclarent grants Entellus a nonexclusive, worldwide license under the
Licensed Patents to make, have made, use, sell, offer to sell, import or otherwise dispose of, the Covered Products for use in the Field. Entellus shall not manufacture for, have manufactured for, or sell Covered Products under labels or brand names
other than its own respective labels and brand names, or in any way create a de facto sublicense, unpermitted assignment or private labeling arrangement with a third party. For sake of clarity, the license granted under this Article 5.1 is limited
to Covered Products and does not extend to any Staple Products referred to in Article 2.6 above. 
 5.2 Entellus shall have the right to
extend the licenses granted herein to any of its Affiliates, upon the terms and conditions of this Agreement, provided Entellus agrees in writing to be responsible for the performance by such Affiliates of all of Entellus’ obligations
hereunder, including the payment of royalties set forth in Article 6.1 herein on Net Sales of the Covered 

  
 [***] CERTAIN INFORMATION IN THIS
DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION. 

  
 - 3 - 

 
Products by the Affiliates to whom the licenses have been extended. Entellus shall not have the right to grant any sublicenses under this Agreement. 

ARTICLE 6—PAYMENTS 

6.1 Royalty Payments In further consideration for the license granted to Entellus under Article 5 herein, Entellus shall pay Acclarent
on a quarterly basis pursuant to Article 8.1 below for the term of this Agreement 
 (a) from the Effective Date of this
Agreement until September 30, 2022, royalty of [***] percent ([***] %) on Net Sales of Covered Products that are manufactured or sold in a country in which the manufacture, sale or use of the Covered Product would, but for the
terms of this Agreement, infringe a Valid Claim of the Licensed Patents. 
 (b) from September 30, 2022 until the
date upon which the last of the Licensed Patents expire or is abandoned, [***] percent ([***]%) on Net Sales of Covered Products that are manufactured or sold in a country in which the manufacture, sale or use of the Covered Product
would, but for the terms of this Agreement, infringe a Valid Claim of the Licensed Patents. 
 No royalties shall be payable under this Article 6.1
on Net Sales of the Covered Products in conjunction with clinical tests or trials. Specifically, no royalties shall be payable on Net Sales of the Covered Products sold before obtaining Regulatory Approval. Furthermore, no multiple royalties shall
be payable because a Covered Product is covered by more than one of the Licensed Patents. 
 Entellus stipulates that royalties will be payable under this
Article 6.1 for the Net Sales of the products listed in Appendix A that are manufactured or sold in the United States, at least for so long as such products are sold for use or intended use in the same manner as of the Effective Date. 

6.2 Within [***] days of the Effective Date of this Agreement, Entellus shall pay Acclarent a lump sum equal to royalties that
would have been due to date under Article 6.1(a) above, had this Agreement been in effect as of July 28, 2010. 
 6.3 Minimum
Royalty Payments Entellus shall not have any minimum royalty obligations under this Agreement. However, Entellus may [***]. Should the [***], then such [***]. In the event that [***] under this Agreement, then
[***]. 

  
 [***] CERTAIN INFORMATION IN THIS
DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION. 

  
 - 4 - 

 ARTICLE 7—ENTELLUS RECORD KEEPING AND REPORTS 

7.1 Entellus shall keep accurate books and records of the Net Sales of Covered Products, and of all payments due Acclarent hereunder. Entellus
shall deliver to Acclarent written reports of Net Sales of Covered Products during the preceding Calendar Quarter, on or before the [***] day following the end of each Calendar Quarter. Such report shall include a calculation of the royalty due and
shall be accompanied by the monies due. The royalty payable on Net Sales of the Covered Products outside the U.S. shall be estimated for each Calendar Quarter, and adjusted at the end of each calendar year to reflect actual sales and the royalty
payable thereon. 
 7.2 Acclarent shall have the right after [***] days advance written notice to Entellus, [***], to nominate
an independent accountant acceptable to and approved by Entellus (which approval shall not be unreasonably withheld) who shall have access to Entellus’ records during reasonable business hours for the sole purpose of verifying the royalties
payable as provided for in this Agreement for the preceding calendar year, but this right may not be exercised more than once in any calendar year. Acclarent shall solicit or receive only information relating solely to the accuracy of the royalty
report and the royalty payments made according to this Agreement. Entellus shall be entitled to withhold approval of an accountant that Acclarent nominates unless the accountant shall agree to sign a confidentiality agreement with Entellus that
obligates such accountant to hold the information it receives from Entellus in confidence, except for information necessary for disclosure to Acclarent to establish the accuracy of the royalty reports. If an audit made pursuant to this Article 7.2
above produces a discrepancy of greater than [***]%, then Acclarent shall have the right to re-audit upon demand and with [***] prior notice to Entellus [***], and Entellus shall bear the cost of the audit that produced such a
discrepancy. 
 7.3 Acclarent shall retain in confidence, the results of all information received related to Net Sales of the Covered
Products and any audit information. All such information received by Acclarent shall be disclosed solely to Acclarent’s President, Chief Financial Officer, finance staff at Acclarent or its Affiliates with royalty accounting
responsibility, and internal and external counsel and financial personnel who shall use the information solely for financial auditing or reporting purposes or for remedying any failure to pay royalties due and shall not disclose it to any other
person within Acclarent or its Affiliates, except as required in the normal course of reporting financial results, or as may otherwise be required by law. 

ARTICLE 8—CURRENCY AND ROYALTY TRANSFER 

8.1 Royalties based on sales in any country shall be paid in United States Dollars. The rate of exchange for such payments from sales in a
foreign country shall be the official rate of exchange of the currency of the country from which royalties are payable as quoted by the Wall Street Journal, New York Edition, on the last business day of the Calendar Quarter

  
 [***] CERTAIN INFORMATION IN THIS
DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION. 

  
 - 5 - 

 
for which the royalties are payable. The payment of royalties shall be made payable to Acclarent and sent to the address set forth for Acclarent in Article 15.3. 

8.2 If a foreign government prohibits the transfer of royalties based on sales in foreign countries out of a particular foreign country,
Entellus has the right to place Acclarent’s royalties in an independent bank account in the name of Acclarent and under the complete control of Acclarent, provided that Entellus informs Acclarent of the name of the bank, the bank account number
and the amount of money deposited therein. After Acclarent has been so notified, those monies will be considered completely controlled by Acclarent, and Entellus will not have any further responsibility or claim to those monies or that bank account.
Acclarent shall cooperate with Entellus to establish such an account if requested by Entellus. 
 ARTICLE 9—MOST FAVORED LICENSEE

 9.1 In the event that Acclarent grants a license to a third party under any of the Royalty Generating Patents that [***], then
Acclarent shall notify Entellus of the [***] of such other license within [***] of completion of such Third Party License Agreement. 

9.2 If the Third Party License Agreement does not [***], then Entellus shall have the right to [***] the Third Party
License Agreement within [***] from the receipt of such notice from Acclarent. 
 9.3 If the Third Party License
Agreement [***], then Entellus shall have the right to [***]. Acclarent shall notify Entellus within [***]. 

9.4 The provisions of this Article 9 shall not apply to any Third Party License Agreement that 

 

	 	i)	[***]; 

  

	 	ii)	[***]; or 

  

	 	iii)	[***]. 

  
 [***] CERTAIN INFORMATION IN THIS
DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION. 

  
 - 6 - 

 This Article 9 also shall not apply to licenses with any affiliate within the Johnson & Johnson family
of companies. 
 ARTICLE 10—PATENT ENFORCEMENT. PROSECUTION AND MAINTENANCE 

10.1 Acclarent is solely responsible but not obligated, within its sole discretion, for the enforcement of the Licensed Patents, and for the
continued prosecution of pending patent applications within the Licensed Patents, and the issuance and maintenance of the Licensed Patents. 

10.2 Notwithstanding Article 10.1 above, if Entellus becomes aware of any third-parties that may be infringing the Licensed Patents in
the Field, then Entellus shall notify Acclarent in writing of such potential infringement within [***]. 
 10.3 Upon request by
Entellus, Acclarent shall inform Entellus of the status of any of the Licensed Patents. 
 ARTICLE 11—COVENANTS. WARRANTIES AND
REPRESENTATIONS 
 11.1 Each party represents and warrants to the other party that (a) it has full right, power and authority to
enter into and be bound by the terms and conditions of this Agreement, to transfer the rights and to carry out their respective obligations under this Agreement without the approval or consent of any other person, (b) the entering into of this
Agreement, the transfer of rights and the carrying out of their respective obligations under this Agreement is not prohibited, restricted or otherwise limited by any contract, agreement or understanding entered into by such party, or by which such
party is bound, with any other person, including, without limitation, any governmental authority, (c) there is no contract, agreement or understanding entered into by a party, or by which such party is bound, which if enforced, terminated or
modified, would be in derogation of, contrary to, or adversely affect the rights acquired or to be acquired hereunder, and (d) there is no action or investigation pending or currently threatened against such party which, if adversely
determined, would restrict or limit such party’s right to enter into this Agreement. 
 11.2 Acclarent does not warrant, in particular,
the validity of the Licensed Patents, nor the freedom to exploit the inventions or technical solutions described in the Licensed Patents. 

11.3 Acclarent expressly warrants and represents that a) it owns all of the right, title and interest in and to the Licensed Patents; b) it is
empowered to grant the licenses granted herein; c) it has no outstanding encumbrances or agreements, including any agreements with academic institutions, universities, or third party employers, whether written, oral or implied, which would be
inconsistent with the licenses granted herein. 

  
 [***] CERTAIN INFORMATION IN THIS
DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION. 

  
 - 7 - 

 11.4 Acclarent covenants not to sue Entellus for infringement of any Licensed Patent in
connection with Entellus’ sale, marketing, use, import or export of any Covered Product in the Field. 
 11.5 Entellus its Affiliates,
successors and assigns covenant that they will not attack the validity or enforceability of the Licensed Patents in any manner and by any means, including litigation and/or reexamination, and that they will not assist any third party in doing the
same. Notwithstanding the foregoing, if [***]. For sake of clarity, Entellus shall [***] under this Agreement. 
 11.6
Notwithstanding the foregoing, nothing in this Agreement shall preclude Entellus from raising any defenses in a patent infringement litigation brought by Acclarent against Entellus. 

11.7 Entellus expressly agrees to provide Acclarent with [***]. 

ARTICLE 12—TAXES 

12.1 Entellus will make all payments to Acclarent under this Agreement without deduction or withholding for taxes except to the extent that
any such deduction or withholding is required by law in effect at the time of payment. 
 12.2 Any tax required to be withheld on
amounts payable under this Agreement will promptly be paid [***] to the appropriate governmental authority, and [***] of such tax. Any such tax required to be withheld will be [***]. 

ARTICLE 13—MARKING 

13.1 For all Covered Products, at the request of Acclarent, Entellus shall mark the IFUs, packaging and promotional materials (e.g. FDA
labeling) with the Licensed Patents in a commercially reasonable manner. 
 ARTICLE 14—TERMINATION 

14.1 Acclarent may terminate this Agreement upon sixty (60) days written notice to Entellus for any material breach or default by
Entellus. Such termination shall become effective 

  
 [***] CERTAIN INFORMATION IN THIS
DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION. 

  
 - 8 - 

 
at the end of the sixty (60) day period unless during such period Entellus cures such breach or default. Notwithstanding the preceding sentence, from the date either party notifies the other
party that it wishes to commence a proceeding in accordance with the dispute resolution procedures set forth in Appendix B, until the date such proceeding has been concluded, the running of the time period referred to in this Article 14.1 for curing
a breach shall be suspended with respect to the subject matter of the dispute, claim or controversy. 
 14.2 If all claims of the Licensed
Patents reading on the use or sale of a Covered Product are found to be invalid or unenforceable under a final decision by a court or other governmental agency of competent jurisdiction, then Entellus’ royalty obligations for that Covered
Product shall terminate effective as of the date of such final decision. 
 ARTICLE 15—MISCELLANEOUS 

15.1 Marketing Obligations Acclarent acknowledges that Entellus [***], and therefore, shall [***]. 

15.2 Confidentiality and Publicity Neither party shall disclose the financial terms of this Agreement to an unaffiliated third party
without the prior written approval of the other party, except for legal, financial, accounting or other similar advisors who have a need to know any of such terms and agrees to keep them confidential. The confidentiality obligations of the parties
under this Article 15.2 shall not extend to disclosure which is required by any governmental agency or regulatory body, court order or otherwise required by law, or to the extent required to preserve, exercise or enforce rights under this Agreement.
Furthermore, neither party will originate any news release, or other public announcement, written or oral, whether to the public press, to stockholders, or otherwise, relating to this Agreement, to any amendment hereto or to performance hereunder or
the existence of an arrangement between the parties without the prior written approval of the other party. An Entellus Press Release related to the completion of this agreement is in Appendix D and is approved with the signing of this agreement.
Notwithstanding the foregoing, Entellus shall have the right to disclose the terms of this Agreement to current shareholders and in connection with bona fide fund raising or sale of the company stock provided that such disclosure is no broader than
necessary to satisfy such purposes, and is made under a confidentiality agreement including substantially similar confidentiality terms as this Article 15.2. Notwithstanding the foregoing, for the sole purpose of settling a third party infringement
action involving the Licensed Patents, or settling with a third party accused of infringing the Licensed Patents, Acclarent shall have the right to disclose the existence of this Agreement and the royalty rate set forth herein. 

15.3 Notices All notices hereunder shall be in writing and shall be deemed to have been duly given if delivered personally, one day
after delivery to a nationally recognized overnight delivery service, charges prepaid, three days after sent by registered or certified mail, postage prepaid, or when receipt is confirmed if by, facsimile or other telegraphic means: 

  
 [***] CERTAIN INFORMATION IN THIS
DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION. 

  
 - 9 - 

 In the case of Acclarent: 

President 
 Acclarent, Inc. 

1525-B O’Brien Drive 
 Menlo
Park, CA 94025 
 With a copy to: 

Chief Patent Counsel 

Johnson & Johnson 
 One
Johnson & Johnson Plaza 
 New Brunswick, New Jersey 08933 

In the case of Entellus: 

President and Chief Executive Officer 

Entellus Medical, Inc. 
 6705
Wedgwood Court North 
 Maple Grove, MN 55311 

With a copy to: 
 Director,
Intellectual Property 
 Entellus Medical, Inc. 

6705 Wedgwood Court North 
 Maple
Grove, MN 55311 
 Such addresses may be altered by written notice given in accordance with this Article 15.3. 

15.4 Assignment Either party may assign this Agreement or any rights and obligations contemplated herein to an Affiliate of that
party or to a company acquiring substantially all of the assets of that party to which this Agreement relates, without the consent of the other party, upon giving written notice thereof to the other party. Acclarent may assign its right to receive
payments under this Agreement to any third party, upon giving written notice of such assignment to Entellus. Any such assignment shall be subject to the terms of this Agreement. In all other instances, neither party shall assign this Agreement, any
portion thereof or any rights granted hereunder without the prior written consent of the other party. Subject to the foregoing, this Agreement shall bind and inure to the benefit of the respective parties hereto, and their respective heirs,
officers, directors, representatives, agents, successors, assigns, distributors, suppliers, vendors and customers. 

  
 - 10 - 

 15.5 Force Majeure Any delays in or failures of performance by either party under this
Agreement shall not be considered a breach of this Agreement if and to the extent caused by occurrences beyond the reasonable control of the party affected, including but not limited to: acts of God; acts, regulations or laws of any government;
strikes or other concerted acts of workers; fires; floods; explosions; riots; wars; rebellions; and sabotage; and any time for performance hereunder shall be extended by the actual time of delay caused by such occurrence. 

15.6 Relationship of Parties The parties hereto are entering into this Agreement as independent contractors, and nothing herein is
intended or shall be construed to create between the parties a relationship of principal and agent, partners, joint venturers or employer and employee. Neither party shall hold itself out to others or seek to bind or commit the other party in any
manner inconsistent with the foregoing provisions of this Article. 
 15.7 Dispute Resolution The parties agree to be bound by the
dispute resolution provisions set forth in Appendix B attached hereto. 
 15.8 Severability If any provision of this Agreement is held
to be illegal, invalid, or unenforceable under any applicable present or future law, and if the rights or obligations of any party hereto under this Agreement will not be materially and adversely affected thereby, then (a) such provision
will be fully severable; (b) this Agreement will be construed and enforced as if such illegal, invalid, or unenforceable provision had never been a part hereof; (c) the remaining provisions of this Agreement will remain in full force and
effect and will not be affected by the illegal, invalid, or unenforceable provision or by its severance herefrom; and (d) in lieu of such illegal, invalid, or unenforceable provision, the parties hereto will negotiate in good faith and add
as part of this Agreement a valid and enforceable provision as similar in substance to such illegal, invalid, or unenforceable provision as may be possible. 

15.9 Integration It is the mutual desire and intent of the parties to provide certainty as to their future rights and remedies
against each other by defining the extent of their mutual undertakings as provided herein. The parties have in this Agreement incorporated all representations, warranties, covenants, commitments and understandings on which they have relied in
entering into this Agreement and, except as provided for herein, neither party has made any covenant or other commitment to the other concerning its future action. Accordingly, this Agreement constitutes the entire agreement and understanding
between the parties with respect to the matters contained herein, and there are no prior oral or written promises, representations, conditions, provisions or terms related thereto other than those set forth in this Agreement. The parties may from
time to time during the term of this Agreement modify any of its provisions by mutual agreement in writing. 
 15.10 Headings The
inclusion of headings in this Agreement is for convenience only and shall not affect the construction or interpretation hereof. 
 15.11
Governing Law This Agreement shall be governed and interpreted under the laws of the State of New Jersey, without regard for conflicts of law. 

  
 - 11 - 

 This Agreement is signed below by duly authorized representatives of Acclarent and the Entellus,
respectively. 
  

									
	Acclarent, Inc.	 		 	Entellus Medical, Inc.
					
	By:	 	 /s/ Bill Facteau
	 		 	By:	 	 /s/ Brian Farley

	Bill Facteau, President	 		 	Brian Farley, President and CEO
				
	Date:	 	2/15/2011	 		 	Date: 2-17-11

  
 - 12 - 

 APPENDIX A 

Covered Products 
 The following
Covered Products listed in this Appendix A, and any respective components, are licensed under Section 5 of this Agreement whether sold individually or pre-packaged in kits. 

(1) The FinESS® Sinus Treatment Product Gen 2 (“Gen 2 FinESS®”) which is described in the attached Instructions for Use dated July 2010 (Rev D) (Exhibit 1 to this Appendix A), and as currently sold under Entellus catalog number BC-500 as a kit that
includes the following components: 
 Canine fossa micro trocar 

Canine fossa access sheath with side cutting 
 Cannula
with lumens for endoscope and balloon 
 Balloon dilation catheter 

Inflation device without gauge 
 Extension tubing

 (2) The Entellus Endoscope bundle currently sold by Entellus for use with Gen 2
FinESS® under Entellus catalog number ES-100b, which is described in the attached Instructions for Use dated January 2011 (Exhibit 2 to this Appendix A), which includes a flexible endoscope
with fixed focus. 
 (3) The Entellus flexible endoscope with a protective sheath (which is illustrated in the photograph attached as Exhibit 3
to this Appendix A) and the Entellus flexible endoscope with a focus ring (which is illustrated in the photograph attached as Exhibit 4 to this Appendix A), both of which are currently 510(k) cleared or exempt, but not currently marketed. 

(4) The currently existing canine fossa access sheath without side cutting for use with a
FinESS® product, which is 510(k) cleared or exempt, but not currently marketed. 

(5) The FinESS® Gen 3 (“Gen3
FinESS®”) product for which 510(k) clearance is currently pending, and that includes the components shown in the attached draft Instructions for Use dated May 2010 (rev C) (Exhibit 5 to
this Appendix A) and is identified by Entellus catalog number BC-700. 
 (6) The FinESS®
Gen 3 endoscope (“Gen3 Scope”) product for which 510(k) clearance is currently pending and which is described in the attached draft Instructions for Use dated January 13, 2011 (Exhibit 6 to this Appendix A). 

(7) A sterilization tray for use with the Gen3 Scope. 

(8) The XprESSTM Sinus Treatment Product (“XprESSTM”) which is described in the attached Instructions for Use dated October 2010
(Exhibit 7 to this Appendix A), and as currently sold under Entellus catalog number JD-100. 

  
 - 13 - 

 (9) The XprESSTM Sinus Treatment Product with semi-rigid tip (“Semi-Rigid XprESSTM”)
that differs from XprESSTM only in having a semi-rigid tip rather than a shapeable tip. 
 (10) The FinESS® Sinus Treatment Product Gen 1 (“Gen 1 FinESS®”) which is described in the attached Instructions for Use dated March 2010
(Exhibit 8 to this Appendix A), and was or is sold under Entellus catalog number BC5OO as a kit that includes the following components: 
 Canine
fossa micro trocar 
 Canine fossa access sheath with side cutting 

Cannula with lumens for endoscope and balloon 
 Balloon
dilation catheter 
 Inflation device with gauge 

Extension tubing 

  
 - 14 - 

 APPENDIX B—DISPUTE RESOLUTION 

ARBITRATION 
  

	 	a.	Any dispute, claim or controversy arising from or related in any way to this Agreement or the interpretation, application, breach, termination or validity thereof, including any claim of inducement of this Agreement by
fraud or otherwise, will be submitted for resolution to arbitration pursuant to the rules then pertaining of the International Institute for Conflict Prevention and Resolution for Non-Administered Arbitration (available at
http://www.cpradr.org/arb-intro.asp?M=9.3), or successor (“CPR”), except where those rules conflict with these provisions, in which case these provisions control. The arbitration will be held in New Brunswick, New Jersey.

  

	 	b.	The panel shall consist of three arbitrators chosen from the CPR Panels of Distinguished Neutrals (or, by agreement, from another provider of arbitrators) each of whom is a lawyer with at least 15 years experience
practicing patent law and with a law firm or corporate law department of over 25 lawyers or who was a judge of a court of general jurisdiction. In the event the aggregate damages sought by the claimant are stated to be less than $5 million, and the
aggregate damages sought by the counterclaimant are stated to be less than $5 million, and neither side seeks equitable relief, then a single arbitrator shall be chosen, having the same qualifications and experience specified above. Each arbitrator
shall be impartial and independent of the parties and, for at least a period of ten years prior to the effective date of this agreement, shall not have been employed by, or worked for a law firm that is or has been retained by either party or by any
affiliate of either party. Each arbitrator shall abide by the Code of Ethics for Arbitrators in Commercial Disputes (available at http://www.adr.org/EthicsAndStandards). 

 

	 	c.	The parties agree to cooperate (1) to attempt to select the arbitrator(s) by agreement within 45 days of initiation of the arbitration, including jointly interviewing the final candidates, (2) to meet with the
arbitrator(s) within 45 days of selection and (3) to agree at that meeting or before upon procedures for discovery and as to the conduct of the hearing which will result in the hearing being concluded within no more than nine (9) months
after selection of the arbitrator(s) and in the award being rendered within 60 days of the conclusion of the hearings, or of any post-hearing briefing, which briefing will be completed by both sides within 45 days after the conclusion of the
hearings. 

  

	 	d.	In the event the parties cannot agree upon selection of the arbitrator(s), the CPR will select arbitrator(s) as follows: CPR shall provide the parties with a list of no less than 25 proposed arbitrators (15 if a single
arbitrator is to be selected) having the credentials referenced above. Within 25 days of receiving such list, the parties shall rank at least 65% of the proposed arbitrators on the initial CPR list, after exercising cause challenges. The parties may
then interview the five candidates (three if a single arbitrator is to be selected) with the highest combined rankings for no more than one hour each and, following the interviews, may exercise one peremptory challenge each. The panel will consist
of the remaining three candidates (or one, if one arbitrator is to be selected) with the highest combined rankings. In the event these procedures fail to result in selection of the required number of arbitrators, CPR shall select the
appropriate number of arbitrators from among the members of the various CPR Panels of Distinguished Neutrals, allowing each side challenges for cause and three peremptory challenges each. 

 

	 	e.	In the event the parties cannot agree upon procedures for discovery and conduct of the hearing meeting the schedule set forth in paragraph c above, then the arbitrator(s) shall set dates for the hearing, any
post-hearing briefing, and the issuance of the award in accord with the paragraph c schedule. The arbitrator(s) shall provide for discovery according to those time limits, giving recognition to the understanding of the parties that they contemplate
reasonable discovery, including document demands and depositions, but that such discovery be limited so that the paragraph c schedule may be met without difficulty. In no event will the arbitrator(s), absent agreement of the parties, allow more than
a total of ten days for the hearing or permit either side to obtain more than a total of 40 hours of deposition testimony from all witnesses, including both fact and expert witnesses, or serve more than 20 individual requests for documents,
including subparts, or 20 individual requests for admission or interrogatories, including subparts. Multiple hearing days will be scheduled consecutively to the greatest extent possible. 

 

	 	f.	The arbitrator(s) must render their award by application of the substantive law of New Jersey and are not free to apply “amiable compositeur” or “natural justice and equity.” The arbitrator(s) shall
render a written opinion setting forth findings of fact and conclusions of law with the reasons therefor stated. A transcript of the evidence adduced at the hearing shall be made and shall, upon request, be made available to either party. The
arbitrator(s) shall have power to exclude evidence on grounds of hearsay, prejudice beyond its probative value, redundancy, or irrelevance and no award shall be overturned by reason of such ruling on evidence. To the extent possible, the arbitration
hearings and award will be maintained in confidence. 

  

	 	g.	 In the event the panel’s award exceeds $5 million in monetary damages or includes or consists of equitable relief, or rejects a claim in excess
of that amount or for that relief, then the losing party may obtain review of the arbitrators’ award or decision by a single appellate arbitrator (the “Appeal Arbitrator”) selected from the CPR Panels of Distinguished Neutrals by
agreement or, failing agreement within seven working days, pursuant to the selection procedures specified in paragraph d above. If CPR cannot provide such services, the parties will together select another provider of arbitration services that can.
No Appeal Arbitrator shall 

  
 - 15 - 

	 	
be selected unless he or she can commit to rendering a decision within forty-five days following oral argument as provided in paragraph h. Any such review must be initiated within thirty
(30) days following the rendering of the award referenced in f above. 

  

	 	h.	The Appeal Arbitrator will make the same review of the arbitration panel’s ruling and its bases that the U.S. Court of Appeals of the Circuit where the arbitration hearings are held would make of findings of fact
and conclusions of law rendered by a district court after a bench trial and then modify, vacate or affirm the arbitration panel’s award or decision accordingly, or remand to the panel for further proceedings. The Appeal Arbitrator will consider
only the arbitration panel’s findings of fact and conclusions of law, pertinent portions of the hearing transcript and evidentiary record as submitted by the parties, opening and reply briefs of the party pursuing the review, and the answering
brief of the opposing party, plus a total of no more than four (4) hours of oral argument evenly divided between the parties. The party seeking review must submit its opening brief and any reply brief within seventy-five (75) and one
hundred thirty (130) days, respectively, following the date of the award under review, whereas the opposing party must submit its responsive brief within one hundred ten (110) days of that date. Oral argument shall take place within five
(5) months after the date of the award under review, and the Appeal Arbitrator shall render a decision within forty-five (45) days following oral argument. That decision will be final and not subject
to further review, except pursuant to the Federal Arbitration Act. 

  

	 	i.	The parties consent to the jurisdiction of the Federal District Court for the district in which the arbitration is held for the enforcement of these provisions and the entry of judgment on any award rendered hereunder
(including after review by the Appeal Arbitrator where such an appeal is pursued). Should such court for any reason lack jurisdiction, any court with jurisdiction shall act in the same fashion. 

 

	 	j.	Each party has the right before or, if the arbitrator(s) cannot hear the matter within an acceptable period, during the arbitration to seek and obtain from the appropriate court provisional remedies such as attachment,
preliminary injunction, replevin, etc. to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the arbitration. 

  

	 	k.	EACH PARTY HERETO WAIVES ITS RIGHT TO TRIAL OF ANY ISSUE BY JURY. 

  

	 	l.	EACH PARTY HERETO WAIVES ANY CLAIM TO PUNITIVE, EXEMPLARY OR MULTIPLIED DAMAGES FROM THE OTHER. 

  

	 	m.	EACH PARTY HERETO WAIVES ANY CLAIM OF CONSEQUENTIAL DAMAGES FROM THE OTHER. 

  

	 	n.	EACH PARTY HERETO WAIVES ANY CLAIM FOR ATTORNEYS’ FEES AND COSTS AND PREJUDGMENT INTEREST FROM THE OTHER. 

MEDIATION 
  

	 	a.	Any dispute, controversy or claim arising out of or related to this agreement, or the interpretation, application, breach, termination or validity thereof, including any claim of inducement by fraud or otherwise, which
claim would, but for this provision, be submitted to arbitration shall, before submission to arbitration, first be mediated through non-binding mediation in accordance with The CPR Mediation Procedure then in effect of the International Institute
for Conflict Prevention and Resolution (CPR) available at www.cpradr.org/m_proced.htm, except where that procedure conflicts with these provisions, in which case these provisions control. The mediation shall be conducted in New Brunswick, New Jersey
and shall be attended by a senior executive with authority to resolve the dispute from each of the operating companies that are parties. 

  

	 	b.	The mediator shall be neutral, independent, disinterested and shall be selected from a professional mediation firm such as JAMS or CPR. 

 

	 	c.	The parties shall promptly confer in an effort to select a mediator by agreement. In the absence of such an agreement within 10 days of initiation of the mediation, the mediator shall be selected by CPR as
follows: CPR shall provide the parties with a list of at least 15 names from the CPR Panels of Distinguished Neutrals. Each party shall exercise challenges for cause, two peremptory challenges, and rank the remaining candidates within 5 working days
of receiving the CPR list. The parties may together interview the three top-ranked candidates for no more than one hour each and, after the interviews, may each exercise one peremptory challenge. The mediator shall be the remaining candidate with
the highest aggregate ranking. 

  

	 	d.	The mediator shall confer with the parties to design procedures to conclude the mediation within no more than 45 days after initiation. Under no circumstances may the commencement of arbitration under this Appendix B be
delayed more than 45 days by the mediation process specified herein absent contrary agreement of the parties. 

  
 - 16 - 

	 	e.	Each party agrees not to use the period or pendency of the mediation to disadvantage the other party procedurally or otherwise. No statements made by either side during the mediation may be used by the other or referred
to during any subsequent proceedings. 

  

	 	f.	Each party bas the right to pursue provisional relief from any court, such as attachment, preliminary injunction, replevin, etc., to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the
arbitration, even though mediation has not been commenced or completed. 

  
 - 17 - 

 APPENDIX C 

STIPULATIONS 

  
 - 18 - 

 RICHARD GOETZ (S.B. #115666) 

O’MELVENY & MYERS LLP 
 400 South Hope Street 

Los Angeles, CA 90071-2899 

			
	Telephone:	  	(213) 430-6000
	Facsimile:	  	(213) 430-6407
	E-Mail:	  	rgoetz@omm.com

 ROBERTA VESPREMI (S.B. #225067) 

O’MELVENY & MYERS LLP 
 2765 Sand Hill Road 

Menlo Park, CA 94025 

			
	Telephone:	  	(650) 473-2600
	Facsimile:	  	(650) 473-2601
	E-Mail:	  	rvespremi@omm.com

 Attorneys for Plaintiff 

ACCLARENT, INC. 
 UNITED STATES DISTRICT COURT

 NORTHERN DISTRICT OF CALIFORNIA 

SAN JOSE DIVISION 
  

					
			
	 ACCLARENT, INC.,
	  		  	Case No. C-10-003311 EMC
			
	 Plaintiff,
	  		  	NOTICE OF DISMISSAL
			
	 v.
	  		  	
			
	 ENTELLUS MEDICAL, INC.,
	  		  	
			
	 Defendant.
	  		  	
		  		  	

 NOTICE OF DISMISSAL 

 NOTICE IS HEREBY GIVEN that pursuant to Rule 41(a) of the Federal Rules of Civil Procedure,
Plaintiff Acclarent, Inc. hereby dismisses with prejudice its complaint against defendant Entellus Medical, Inc., Case Number C-10-003311 EMC. 
  

							
	Dated:
                                	 	 	 	O’MELVENY & MYERS LLP
		 		 	By:	 	  

		 		 		 	Roberta H. Vespremi
				
		 		 		 	2765 Sand Hill Road
		 		 		 	Menlo Park, California 94025
		 		 		 	Telephone: (650) 473-2600
		 		 		 	Facsimile: (650) 473-2601
		 		 		 	E-Mail: rvespremi@omm.com
				
		 		 		 	RICHARD B. GOETZ
		 		 		 	O’MELVENY & MYERS LLP
		 		 		 	400 South Hope Street
		 		 		 	Los Angeles, California 90071
		 		 		 	Telephone: (213) 430-6000
		 		 		 	Facsimile: (213) 430-6407
		 		 		 	E-Mail: rgoetz@omm.com
				
		 		 		 	Attorneys for Plaintiff
		 		 		 	ACCLARENT, INC.
		 		 		 	NOTICE OF DISMISSAL

  

					
		 	- 2 -	 	NOTICE OF DISMISSAL

 APPENDIX D 

PRESS RELEASE 
 Entellus Medical Settles
Patent Dispute 
 Maple Grove, MN, (insert date) — Entellus Medical today announced that it has entered into a licensing agreement with Acclarent,
Inc. in order to resolve their patent lawsuit. The license agreement is royalty bearing to Acclarent. Additional financial details were not disclosed. 
 As
part of the agreement, the companies will file a joint request for the termination of a patent infringement proceeding brought by Acclarent against Entellus on July 28, 2010 in the U.S. District Court for the Northern District of California.

 “We are pleased to have reached a mutually beneficial arrangement,” said Brian Farley, Entellus President and CEO. 

About Entellus Medical 
 Entellus Medical provides
minimally invasive therapeutic solutions to healthcare providers and their patients who suffer from sinusitis. Based in Maple Grove, Minn., Entellus Medical manufactures, markets, and distributes its products throughout the United States. For more
information about Entellus Medical, FinESS Sinus Treatment and the XprESS Multi-Sinus Dilation Tool, visit www.entellusmedical.com or call 763-463-1595. 

  
 - 19 - 

 Exhibit 1 

  
 

 
  
 

 
 Entellus Medical Functional INfundibular 

Endoscopic Sinus System. 

INSTRUCTIONS FOR USE 
 ALL
INSTRUCTIONS, PRECAUTIONS AND WARNINGS SHOULD BE CAREFULLY 
 READ AND UNDERSTOOD BEFORE USE. FAILURE TO DO SO MAY RESULT IN 

COMPLICATIONS. 
 All packaging and
referenced Entellus Medical device components 
 are LATEX FREE 

Caution – Federal (USA) law restricts this device to sale by or on the order of a physician. 

 System Description 

The Entellus Medical, Inc. Functional INfundibular Endoscopic Sinus System (FinESS®) includes the following components: 
 Micro-Trocar & Access Sheath 

The Micro-Trocar provides a small access hole into the Maxillary Sinus through the Canine Fossa. The Micro-Trocar also delivers the Access Sheath, which is
intended to maintain consistent access for procedural devices (Cannula / Endoscope & Balloon Catheter). 
  
 

 
 Figure 1 – Sinus Access Tools: Micro-Trocar Inserted Through Access Sheath 

Cannula 
 The Cannula is a dual lumen instrument that
allows both delivery of the Balloon Catheter and visualization with an Endoscope. The Cannula is sized to pass through the Access Sheath. 
  

 
 Figure 2 – Sinus Cannula 

Balloon Catheter 
 The Balloon Catheter is designed to
dilate the maxillary sinus ostium and the ethmoid infundibulum space. The balloon catheter includes a braided shaft design that allows for rotational positioning to accurately deliver the balloon into the ostium while navigating within the parasinus
space. 
  
 

 
 Figure 3 – Sinus Balloon Dilatation Catheter 

  

					
	1108-003 Rev D July 2010	 	FinESS® Sinus Treatment	 	Page 2 of 11

 Inflation Device 

The disposable Entellus Medical, Inc. Inflation Device consists of a syringe barrel, a plunger rod assembly used to generate and control balloon inflation
pressures, and a pressure limit mechanism. The pressure limit mechanism limits the amount of positive pressure the Inflation Device can generate to 12 atm +1 atm (176 psi + 14.7 psi). 

 
 

 
 Figure 4 – Inflation Device 

All components of the FinESS® Sinus Treatment are provided sterile. 

Indication for Use 
 To access and treat the maxillary sinus
ostium and the ethmoid infundibulum in adults with a trans-antral approach. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinus structures. 

Contraindication 
 Patients with thickened polypoid mucosa
excessive enough to inhibit the visualization of the maxillary ostium should not be considered candidates for the FinESS® Sinus Treatment. 

Warnings 
  

	 	•	 	Only physicians possessing sufficient skill and expertise in similar technique (accessing maxillary sinus ostium and ethmoid infundibulum through canine fossa) should perform this procedure. 

 

	 	•	 	Do not use the FinESS® Sinus Treatment if CT image indicates challenging anatomy such as a hypoplastic antrum or polypoid mucosa that may limit success of Canine
Fossa approach. 

  

	 	•	 	Do not use opened or damaged packages . 

  

	 	•	 	The FinESS® Sinus Treatment is intended for single procedure use only. Do not attempt to reuse or re-sterilize. Device integrity may be compromised.

  

	 	•	 	Do not apply excessive penetration force when drilling the canine fossa access hole. Patient injury or device damage may occur. 

  

	 	•	 	Do not exceed the maximum recommended balloon inflation pressure (12 atm). Use of the Entellus Medical Inflation Device is required to prevent over-pressurization. 

 

	 	•	 	Do not advance or withdraw the Balloon when inflated. Mucosa damage or device damage may occur. 

  

	 	•	 	As in any upper airway procedure or sinus surgery, do not use CPAP for approximately 7 days post-procedure with FinESS® Sinus Treatment. CPAP usage prior to soft
tissue healing may result in facial and/or neck swelling due to subcutaneous emphysema. 

 Precautions 

 

	 	•	 	FinESS® Sinus Treatment components should be stored in a cool and dry place. Never use a device that is beyond its expiration date. 

  

					
	1108-003 Rev D July 2010	 	FinESS® Sinus Treatment	 	Page 3 of 11

	 	•	 	FinESS® Sinus Treatment components should be handled with care. Prior to use, and during the procedure, inspect the packaging and components for bends, kinks, or
other damage. Discontinue the use of any component that may have been damaged. 

  

	 	•	 	Pay special attention when advancing or withdrawing the Cannula or Balloon Catheter. Never advance, withdraw or torque any component that meets resistance, as this could cause kinking or breaking. If resistance is
encountered, use endoscopy to help guide device manipulation. If the cause of resistance cannot be determined, withdraw all components as a system. Do not apply downward force with the Canula during removal, as this may cause damage to the cannula.

  

	 	•	 	The Balloon Catheter should only be manipulated under endoscopic observation. 

  

	 	•	 	The Balloon Catheter should be positioned with its curved tip in an inferior orientation when tracking through the maxillary sinus ostium and ethmoid infundibulum to avoid tracking into the agger nasi cell.

  

	 	•	 	Patients should be advised to sneeze with an open mouth and avoid extreme inhalation and blowing through the nose for approximately 7 days post-procedure to reduce the likelihood of inflammation and/or swelling due to
subcutaneous emphysema. 

  

	 	•	 	It is important to review the patient’s CT image prior to performing the FinESS® procedure in order to determine the most appropriate access location.

 Adverse Effects 
 Possible adverse effects
include, but are not limited to, the following: 
  

	 	•	 	Post-operative facial pain 

  

	 	•	 	Excessive bleeding in the nose and at the canine fossa 

  

	 	•	 	Complication from anesthesia 

  

	 	•	 	Fracture of the anterior wall of the maxillary sinus 

  

	 	•	 	Cerebrospinal fluid leak 

  

	 	•	 	Loss of vision or diplopia (double vision) 

  

	 	•	 	Damage to a tooth root or gingiva 

  

	 	•	 	Damage to nerves potentially causing temporary (and occasionally prolonged) numbness to the cheek, lip, or teeth; mid-facial pain; and tooth pain or hypersensitivity 

 

	 	•	 	Facial bruising and swelling 

  

	 	•	 	Swelling of the nose and cheek 

  

	 	•	 	Fever and infection 

  

	 	•	 	Tissue inflammation 

  

	 	•	 	Continued or worsening sinus symptoms 

 Supplies 

The following supplies need to be available and prepped prior to use of the FinESS® Sinus Treatment.

 Note: These supplies are not provided with the FinESS® Sinus Treatment. 

 

	 	•	 	Entellus Flexible Endoscope ES-100 or ES-100a and compatible camera system 

  

	 	•	 	Sterile Saline Solution 

  

	 	•	 	60 cc Syringe (if irrigation is to be performed) 

  

	 	•	 	Needles and Syringes as required for local anesthesia injections 

  

	 	•	 	Suction system 

  

	 	•	 	#5 and #7 Suction Tips 

  

	 	•	 	Other supplies or medication as per established laboratory protocol 

 System Preparation 

 

	1.	Prepare Imaging Sleeve and Endoscope. 

  

  

					
	1108-003 Rev D July 2010	 	FinESS® Sinus Treatment	 	Page 4 of 11

	 	a.	Verify endoscope has been disinfected per appropriate instructions. If using Entellus Flexible Endoscope ES-1 00, proceed to step 2. 

 

	 	b.	Remove the Imaging Sleeve from its sterile package. 

  

	 	c.	While holding the Imaging Sleeve relatively straight, insert the Endoscope into the Male Luer Adapter (see Figure 5) and slide Sleeve over Endoscope. 

Note: The 0.5 mm Endoscope should be handled with care. Avoid stretching or kinking the Endoscope. Device damage may occur. 

 

	2.	Prepare Cannula. 

  

	 	a.	Insert the Endoscope into the Cannula until it is flush with the Cannula tip. 

  

	 	b.	Tighten the scope retention valve (see Figure 2) to secure the scope within the Cannula. Verify the Endoscope is flush or just outside (approximately 0.5 mm) of the Cannula. 

 

	 	c.	Connect Endoscope to Camera System. 

  

	 	d.	While holding the Cannula with the Endoscope Retention Valve positioned down (see Figure 2), rotate the Camera relative to the eyepiece to align the image as desired. 

 

	3.	Prepare Micro-Trocar. 

  

	 	a.	Remove the Micro-Trocar and Access Sheath from their sterile package. 

  

	 	b.	Slide the Access Sheath onto the Micro-Trocar. Rotate Access Sheath on Micro-Trocar until Micro-Trocar Pin engages with Access Sheath allowing Access Sheath to lay flush against the Micro-Trocar (see Figure 1 ).

  

	4a.	Prepare Inflation Device (to prepare the Inflation Device with provided Infusion Line, proceed to step 4b) 

  

	 	a.	Remove the Inflation Device from its sterile package. 

  

	 	b.	Depress the plunger rod fully into the body of the Inflation Device. 

  

	 	c.	Insert the luer end of the Inflation Device into Sterile Saline Solution. Fully retract the plunger rod to the stop position (2nd Detent) as shown in Figure 6. This
will fill the barrel with saline solution. 

  

	 	d.	While holding the Inflation Device with the luer pointed up, advance the plunger rod into the syringe barrel up to the first detent position (shown in Figure 6) to purge air. The Inflation device is now ready to be
connected to the balloon. 

 Note: Inspect the syringe barrel to ensure there is minimal air in the system. If excessive air
remains in the system, repeat steps b – d. 

  

					
	1108-003 Rev D July 2010	 	FinESS® Sinus Treatment	 	Page 5 of 11

  
 

 
 Figure 6 
  

	4b	Prepare Inflation Device with Infusion Line. 

  

	 	a.	Remove the Inflation Device and the Infusion Line from the sterile package. 

  

	 	b.	Connect the Infusion Line to the Inflation Device. 

  

	 	c.	Insert the luer fitting of the Infusion Line into sterile saline solution. Keep the Inflation Device luer pointed up during the prepping steps to prevent air entrapment. 

 

	 	d.	Fully retract the plunger rod to the stop position (2nd Detent) as shown in Figure 6. This will fill the barrel with the saline solution. 

 

	 	e.	Advance the plunger rod fully into the syringe barrel to purge air from the system. 

  

	 	f.	Repeat steps d and e until no more air is present in the system. 

  

	 	g.	With the balloon device full of saline and the plunger fully retracted (to stop position}, advance the plunger to the first detent (Figure 6). The Inflation device is now ready to be connected to the balloon.

 Note: Inspect the syringe barrel to ensure there is minimal air in the system. If excessive air remains in the system,
repeat steps c – d. 
  

	5.	Prepare Balloon Catheter 

  

	 	a.	Remove the Balloon Catheter from its sterile package. 

  

	 	b.	Connect the Balloon Catheter to the Inflation Device (or Infusion Line, if applicable). 

  

	 	c.	While holding the Inflation Device with the Balloon Catheter pointed down, depress the plunger rod with 2 hands, keeping the plunger rod straight, until the distal seal on the orange piston aligns with the distal mark
on the inflation device. 

  

	 	d.	Pull back on the plunger rod to apply a vacuum to the balloon. Lock the plunger rod in position by pulling it back to the second detent. 

 

	 	e.	Remove the Protective Sleeve from the Balloon. Retain the Sleeve for balloon re-wrapping. 

  

					
	1108-003 Rev D July 2010	 	FinESS® Sinus Treatment	 	Page 6 of 11

 System Operation 
  

	1.	Patient preparation. 

  

	 	a.	Patient preparation should be consistent with standard practice. 

  

	 	b.	Anesthesia should be administered appropriately to allow patient tolerance. 

  

	2.	Access Maxillary Sinus 

  

	 	a.	Firmly lift and retract lip to visualize gingival tissue and feel for canine fossa recess. 

  

	 	b.	While retracting lip to minimize gingival tissue thickness, enter tissue with Micro-Trocar. 

  

	 	c.	After accessing gingival tissue, position Micro-Trocar tip on bony surface at the intersection location described in Figure 7. 

Note: The target access location is typically on the lateral side of the canine fossa recess. 

 

	 	Note:	Access location may be confirmed by gently angling the Micro-Trocar to be perpendicular to the facial plane while holding the Micro-Trocar tip on the bone at the target access location. 

 

	 	d.	While holding Micro-Trocar at appropriate angle (approximately 45 degrees from the facial plane with the Micro-Trocar tip pointed at the inside corner of the eye}, apply a back-and-forth rotational motion (versus a
pushing motion) to gently create an access hole. 

  

	 	Note:	Do not apply excessive penetration force when making access hole. 

  

 
 Figure 7 – Target Access Site Location 

 

	 	e.	After sinus access is achieved, continue rotating Micro-Trocar with back-and-forth motion while gently angling the Micro-Trocar tip toward the Maxillary Sinus Ostium (corner of the eye). The gentle side-cutting motion
provides a range of motion for the Cannula to visualize the Sinus Ostium. 

  

	 	Note:	The Micro-Trocar must be rotated with a back-and-forth motion prior to angling the Micro-Trocar. 

  

	 	Note:	The Micro-Trocar Pin must be engaged with the Access Sheath to allow side-cutting. If Pin pulls out of Access Sheath, re-insert and continue Micro-Trocar rotations. 

 

	 	f.	While holding Access Sheath in access site with one hand, slide the Micro-Trocar out of the Access Sheath with the other hand by using thumb to push the Access Sheath off of the Micro-Trocar. Do not apply downward force
with the Micro-Trocar during removal. 

  

					
	1108-003 Rev D July 2010	 	FinESS® Sinus Treatment	 	Page 7 of 11

	 	Note:	If Access Sheath slips out of access site (even if it Is just removed from the hole in the bone) at any time, re-load Access Sheath onto Micro-Trocar and use Micro-Trocar to locate original hole, or to
re-access in a secondary location. Do not attempt to re-access the hole with the Access Sheath only. Access Sheath damage may occur. 

  

	 	g.	Use a standard #5 suction tip to aspirate fluid from the access sheath as required. 

  

	3.	Insert Cannula into Access Sheath under endoscopic visualization. 

  

	 	Note:	The Cannula should be inserted up to the Cannula Shaft Mark (see Figure 2) to ensure the Cannula passes completely through the Access Sheath. Failure to accurately position the Cannula Shaft Mark may result In
balloon damage. 

  

	 	Note	At any time during the procedure, the Cannula may be removed from the Access Sheath to clean the Endoscope by gently pulling the Cannula tip I Endoscope tip across a surgical wipe
soaked in an appropriate cleaning medium. Do not apply downward force with the Cannula during removal. 

  

	4.	Visualize presence of air / fluid level within sinus. 

  

	 	a.	If fluid level impedes endoscopic visualization, aspiration and/or irrigation may be required. 

  

	 	b.	Remove Cannula from Access Sheath to complete aspiration and/or irrigation. 

  

	 	c.	Insert Cannula into Access Sheath. Verify acceptable fluid level. Excess residual saline in the sinus should be gently aspirated through a standard #5 suction device. 

 

	5.	Visualize the maxillary sinus ostium. 

  

	 	a.	While holding the Access Sheath in the access site, gently manipulate the Cannula to visualize the maxillary sinus ostium. 

  

	 	b.	While visualizing the ostium, topical anesthetic may be sprayed through the Cannula for additional topical anesthesia as required. 

  

	 	Note:	Use suction to remove residual anesthetic from Cannula using a standard #5 tip as required. 

  

	6.	Introduce the Balloon Catheter through the Cannula. 

  

	 	Note:	The Balloon Catheter should be tracked through the Cannula while under vacuum from the Inflation Device. 

  

	7.	Advance the Balloon across the ostium under endoscopic visualization. 

  

	 	a.	When the Balloon Catheter tip is positioned just outside of the ostium, advance the balloon into the sinus ostium with the curved catheter tip pointed posterior / inferior. 

Note: The arrow on the Balloon Catheter hub indicates the direction of the tip curve. 

 

	 	b.	Using the Shaft Marker (see Figure 3) as a visual reference for the proximal balloon end, position the Balloon within the ostium / infundibulum. 

 

	 	Note:	The Balloon Catheter may be rotationally steered to allow full insertion of the balloon into the ostium and infundibulum. 

  

	8	Inflate Balloon. 

  

	 	a.	Slowly depress the plunger rod with 2 hands, keeping the plunger rod straight, to inflate the balloon. The pressure should be increased slowly (5-7 seconds) until the distal seal on the orange piston reaches the distal
mark on the inflation device. 

  

	 	Note:	Do not use air or any gaseous medium to inflate the balloon. 

  

	 	b.	Inflate sinus balloon until desired result is achieved. Endoscopically observe balloon dilation. 

  

	 	Note:	Do not exceed the maximum pressure of 12 atm. 

  

					
	1108-003 Rev D July 2010	 	FinESS® Sinus Treatment	 	Page 8 of 11

	 	c.	After balloon dilation is complete, deflate the sinus balloon by gently pulling back on the plunger rod. Confirm the balloon deflation endoscopically. 

 

	 	d.	Lock the plunger rod in place by pulling it back to the second detent position. A stop will prevent the plunger rod form being removed from the inflation device. 

 

	 	e.	Verify the Cannula is inserted into the Access Sheath up to the Shaft Mark to ensure the Cannula tip is inserted beyond the Access Sheath. 

 

	 	f.	Withdraw balloon from Cannula under endoscopic visualization. 

  

	 	Note:	Rotating the Catheter as the Balloon begins to engage the Cannula will assist in balloon withdrawal. 

  

	9.	Endoscopically observe balloon dilation result. 

  

	 	a.	If the maxillary sinus ostium has been adequately dilated, remove Cannula and Access Sheath from access site. Do not apply downward force with the Cannula during removal, as this may cause damage to the cannula.

  

	 	Note:	Adequate dilation can be visually confirmed by observing the balloon during inflation, visually verifying balloon positioning during Inflation, and ensuring that the recommended inflation pressure Is achieved.

  

	 	b.	If additional balloon dilation is required, prepare Balloon Catheter per step 10 and repeat steps for Balloon inflation. 

  

	10.	Prepare Balloon Catheter for additional dilations (if required). 

  

	 	a.	Gently advance the plunger rod into the syringe barrel to expand the balloon using minimal pressure. 

  

	 	b.	Rinse balloon with sterile saline or water. 

  

	 	c.	Wipe balloon dry using gauze pad. 

  

	 	d.	Point the distal tip of the balloon catheter down. Gently pull back on the plunger rod to apply vacuum to the balloon. Lock the plunger rod by pulling it back to the second detent position. 

 

	 	e.	Re-wrap the tri-folded balloon by gently folding the wings around the catheter shaft in a clockwise direction. 

  

	 	f.	Slide the Protective Sleeve on the re-wrapped balloon to restore original balloon profile. 

  

	 	g.	Before additional balloon dilatation, remove the Protective Sleeve from the Balloon. Retain the Sleeve for Balloon re-wrapping. 

  

	11.	Repeat procedure for contralateral maxillary sinus if needed. 

  

	 	Note:	The scope image may need to be re-aligned prior to viewing second side. While holding the Cannula with the Endoscope Retention Valve positioned down (see Figure 2), rotate the Camera relative to the eye
piece to align the image as desired. 

  

	12.	After completing the entire procedure, withdraw all system components and discard. 

  

					
	1108-003 Rev D July 2010	 	FinESS® Sinus Treatment	 	Page 9 of 11

 Limited Warranty 

Entellus Medical, Inc. warrants that reasonable care has been used in the design and manufacture of the
FinESS® Sinus Treatment system. This limited warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether expressed or implied, written or oral, by
operation of law or otherwise including, but not limited to, any implied warranties of merchantability or fitness for a particular purpose, or warranties arising from a course of dealing or usage or trade. Handling, storage, cleaning and
sterilization of the FinESS® Sinus Treatment system, as well as other factors relating to the patient, diagnosis, treatment, medical procedures, and other matters beyond Entellus Medical,
Inc.’s control, directly affect the FinESS® Sinus Treatment system and the results obtained from its use. This limited warranty does not extend to any abuse or misuse of the FinESS® Sinus Treatment system (including, without limitation, off-label use), accident to or neglect of the FinESS® Sinus Treatment system,
failure to follow any instructions or specifications provided with the FinESS® Sinus Treatment system (including, without limitation, any re-use, re-processing or re-sterilization of the
FinESS® Sinus Treatment system not in accordance with such instructions or specifications), in each case whether caused or carried out by Customer or by any third party. 

Entellus Medical’s obligation under this limited warranty is limited, at Entellus Medical, Inc.’s option, to the repair or replacement of the FinESS® Sinus Treatment system for a period of twelve (12) months from the date of purchase (the “Warranty Period”) using commercially reasonable efforts within a reasonable period
of time. Entellus Medical, Inc. shall not be liable for any incidental or consequential loss, damage or expense directly or indirectly arising from use of the FinESS® Sinus Treatment system.
Repair or replacement of the FinESS® Sinus Treatment system shall not extend the term of any applicable warranty and the original term of such warranty shall remain in effect. Repairs,
modifications or alterations of the FinESS® Sinus Treatment system performed by any person or entity other than Entellus Medical, Inc. or approved by Entellus Medical, Inc. in writing shall
nullify and otherwise void all applicable warranties hereunder. 
 Entellus Medical, Inc. shall be obligated to honor the express limited warranties
contained herein only upon receipt of full payment for the FinESS® Sinus Treatment system or otherwise in accordance with the payment terms agreed to by Entellus Medical, Inc. and Customer.

 Entellus Medical, Inc. neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in
connection with the FinESS® Sinus Treatment system. 
 Limitation of Liability 

In no event will either Entellus Medical, Inc. or Customer be liable to the other or to any third party for loss of profit, goodwill or other indirect,
incidental, special or consequential or other similar damages arising out of these Terms and Conditions or any Related Purchase Document. The limitation of liability described in this section is in addition to any limitation provided for by the
Limited Warranty provisions. 

  

					
	1108-003 Rev D July 2010	 	FinESS® Sinus Treatment	 	Page 10 of 11

 Symbols 
  

 
 This product is protected by US Patent No. 7,520,876. Other US Patents Pending. 

©2009 Entellus Medical. All rights reserved. FinESS® is a registered trademark of Entellus Medical. 
  
 

 

  

					
	1108-003 Rev D July 2010	 	FinESS® Sinus Treatment	 	Page 11 of 11

 Exhibit 2 

  
 

 
 Entellus Medical 

Flexible Endoscope with Fixed Eye Piece 

INSTRUCTIONS FOR USE 
 ALL
INSTRUCTIONS, PRECAUTIONS AND WARNINGS SHOULD BE CAREFULLY READ AND UNDERSTOOD BEFORE USE. FAILURE TO DO SO MAY RESULT IN COMPLICATIONS AND WILL VOID ANY EFFECTIVE 

WARRANTY. 
 Caution – Federal
(USA) law restricts this device to sale by or on the order of a physician. 

  

					
	1545-001rC January 2011	 	Flexible Endoscope with Fixed Eye Piece	 	Page 1 of 8

 SYSTEM DESCRIPTION 

The Entellus Medical Flexible Endoscope with Fixed Eye Piece System Includes the following components: 

 

	 	•	 	Flexible Endoscope 

  

	 	•	 	The Flexible Endoscope has 0o direction of view and greater than a 55o field of view. The optimum working distance of the endoscope is between 0 – 20mm and has a working diameter of 0.5mm.

  

	 	•	 	The eye cup of the endoscope is compatible with “B” mount camera couplers. 

INDICATION FOR USE 

The Entellus Flexible Endoscope & Eye Piece is Intended to visualize the Internal cavities of the ear, airways, nose, and sinus
cavities during diagnostic and therapeutic endoscope procedures. The device can be used with compatible video systems. 

CONTRAINDICATIONS 
 The use of
endoscopes are not permissible in situations where endoscopic procedures are contraindicated for medical reasons. 

  

					
	1545-001rC January 2011	 	Flexible Endoscope with Fixed Eye Piece	 	Page 2 of 8

 WARNINGS 
  

	 	•	 	The Flexible Endoscope with Fixed Eye Piece are provided NON-STERILE and must be either disinfected or sterilized prior to each and every use (see Care & Handling, Cleaning, High-Level-Disinfection,
Sterilization sections included within this document). Cleaning, disinfection and/or sterilization of this product must be performed by staff that are skilled in the reprocessing of medical devices following the directions and guidelines provided In
this manual. 

  

	 	•	 	Do not sterilize the Flexible Endoscope with Fixed Eye Piece in an autoclave or other types of steam sterilization. Exposure to temperatures greater than 65oC (150oF) may damage the devices. 

 

	 	•	 	Do not clean the Flexible Endoscope with Fixed Eye Piece with ultrasonic cleaning or automated washing systems. Automated washing or ultrasonic cleaning can permanently damage the endoscope lens and fiber optic
components. 

  

	 	•	 	Do not use an endoscope that has been damaged. Use of equipment that is not in sound working condition could compromise patient safety. 

 

	 	•	 	Do not subject the exposed portion of the endoscope to a radius of curvature less than 15mm. Do not subject the remaining portion of the endoscope to a radius of curvature less than 8cm, damage to the endoscope can
occur. 

  

	 	•	 	High energy light radiated through endoscopes can result In high temperatures in front of the light outlet, at the end faces of the light guide of the endoscope. 

PRECAUTIONS 
  

	 	•	 	Check the Flexible Endoscope with Fixed Eye Piece prior to each use to ensure that it has been property cleaned, disinfected and/or sterilized. 

 

	 	•	 	Prior to use, the Flexible Endoscope with Fixed Eye Piece should be inspected for bends, kinks, or other damage. Verify that an image is being projected through the device by looking through the Eye Piece and pointing
the distal segment of the flexible endoscope towards a bright object. Discontinue the use of the flexible endoscope that may have been damaged or does not project an image. 

 

	 	•	 	If a malfunction should occur during procedural use the flexible endoscope should be carefully removed from the patient. Consult the Return for Service section of this document for customer service contact Information.

 Care & Handling 
 The Flexible
Endoscope with Fixed Eye Piece are constructed with glass fiberoptic and lens components. Special care must be taken In order to prevent damage to the optics and to maintain optimal functionality and longevity of the endoscope. 

 

	 	•	 	Handle the endoscope system first by the scope body and second midway through the flexible segment of the endoscope keeping close observation of the distal end to avoid damage. 

 

	 	•	 	Protect the endoscope system during procedural use and transportation between the procedural room and reprocessing location. Avoid harmful interaction with other surgical instruments or tools. The endoscope has an
exposed distal segment that is subject to damage if misused. 

  

					
	1545-001rC January 2011	 	Flexible Endoscope with Fixed Eye Piece	 	Page 3 of 8

 CLEANING (PRIOR TO DISINFECTION OR
STERILIZATION) 
 Prior to initial use and after every use the endoscope must be cleaned of all tissue, materials and debris
with an enzymatlc cleaner / detergent. The Flexible Endoscope with Eye Piece have been validated through 25 cleaning cycles (ENZOL® Enzymatic Detergent is recommended). This cleaning must be
performed prior to disinfection or sterilization. All instructions provided by the enzymatic detergent manufacturer must be followed when performing the cleaning process. 
  

	 	•	 	Wear all manufacturer recommended personal protective clothing I equipment prior to performing any cleaning procedure. 

  

	 	•	 	Prepare the enzymatic cleaner / detergent per the manufacturer’s instructions. 

  

	 	•	 	Perform the cleaning process paying close attention to the exposed distal segment of the endoscope. This area should be gently but thoroughly wiped to remove any contaminants remaining on the endoscope. If coiling of
the scope occurs during cleaning adhere to the recommendations regarding the minimum bend radius specified In the Warnings section of this document. 

  

	 	•	 	After completing the cleaning cycle rinse the device per the cleaning agent instructions. 

  

	 	•	 	A wipe containing IPA may be used on the lenses of the Flexible Endoscope with Fixed Eye Piece to help remove residual fluid from these surfaces. For best results, wipe across the face of the distal lens.

 HIGH LEVEL DISINFECTION 

The Flexible Endoscope with Fixed Eye Piece can be disinfected with CIDEX® OPA High
Level Disinfecting Solution. The Flexible Endoscope with Fixed Eye Piece have been validated through 25 high level disinfection cycles. All instructions provided by the manufacturer of CIDEX®
OPA should be followed when performing the disinfection process. 
  

	 	•	 	Don personal protective equipment per the CIDEX® OPA recommended instructions. 

 

	 	•	 	Assure that the endoscope has undergone a cleaning process with an enzymatic detergent. 

  

	 	•	 	When placing the endoscope into the reprocessing container adhere to the recommendations regarding the minimum bend radius specified in the Warnings section. 

 

	 	•	 	Perform the CIDEX OPA disinfection process per the manufacturer’s instructions for use. 

  

	 	•	 	Use standard clean techniques to dry the endoscope and pass Into the clean field for procedural use. 

  

	 	•	 	A sterile alcohol wipe may be used on the lenses of the Flexible Endoscope with Fixed Eye Piece to help remove residual fluid from these surfaces. For best results, wipe across the face of the distal lens.

  

					
	1545-001rC January 2011	 	Flexible Endoscope with Fixed Eye Piece	 	Page 4 of 8

 STERILIZATION 

The Flexible Endoscope with Fixed Eye Piece is compatible with STERIS SYSTEM 1E®,
STERRAD® 100S, and STERRAD® NXTM sterilization methods. The Flexible Endoscope with Fixed Eye Piece has been validated through 25
reprocessing cycles. 
 STERIS SYSTEM 1E®—All instructions provided by STERIS
Corporation should be followed when performing the sterilization process. 
  

	 	•	 	The sterilization process should be started within 30 minutes of the cleaning procedure. 

  

	 	•	 	Don personal protective equipment per the STERIS SYSTEM 1E® recommended instructions 

 

	 	•	 	Obtain a compatible reprocessing tray for the Flexible Endoscope with Fixed Eye Piece. STERIS catalog No’s C1200 General Processing Tray, C1220 Directed Flow Processing Tray and Container, and C1140 Flexible
Endoscope Processing Tray and Container are all acceptable for use. 

  

	 	•	 	Place the device into the processing tray in a large radius and adhere to the recommendations regarding the minimum bend radius of the Flexible Endoscope with Fixed Eye Piece specified In the Warnings section. Up to 3
endoscope may be processed per cycle. 

  

	 	•	 	Avoid placing the distal segment of the endoscope in a position that may cause it to be crushed during processing. 

  

	 	•	 	Perform the sterilization process per the STERIS SYSTEM 1E® instructions for use. 

 

	 	•	 	Using standard sterile techniques dry the endoscope and pass into the sterile field for procedural use. 

  

	 	•	 	A sterile alcohol wipe may be used on the lenses of the Flexible Endoscope with Fixed Eye Piece to help remove residual fluid from these surfaces. For best results, wipe across the face of the distal lens.

 STERRAD® 100S & NXTM – All instructions provided
by Advanced Sterilization Products (ASP) should be followed when performing STERRAD sterilization processes. STERRAD sterilization methods use a plasma that is known to cause discoloration to aluminum alloys Discoloration to the Flexible Endoscope
with Fixed Eye Piece may occur after repeated processing but will not affect the system from being sterilized or alter the performance of the device. 
  

	 	•	 	The sterilization process should be started within 30 minutes of the cleaning procedure. 

  

	 	•	 	Don personal protective equipment per the STERRAD recommended instructions 

  

	 	•	 	Obtain a compatible reprocessing tray for the Flexible Endoscope with Fixed Eye Piece. Refer to the Storage & Tray Loading section of this document for recommendations. 

 

	 	•	 	Place the device into the processing tray in a large radius and adhere to the recommendations regarding the minimum bend radius of the Flexible Endoscope with Fixed Eye Piece specified In the Warnings section.

  

	 	•	 	Avoid placing the distal segment of the endoscope In a position that may cause it to be crushed during processing. 

  

	 	•	 	Perform the sterilization process per the STERRAD® instructions for use. 

  

	 	•	 	Using standard sterile techniques pass the endoscope into the sterile field for procedural use. 

  

	 	•	 	A sterile alcohol wipe may be used on the lenses of the Flexible Endoscope with Fixed Eye Piece to help remove residual fluid from these surfaces. For best results, wipe across the face of the distal lens.

  

					
	1545-001rC January 2011	 	Flexible Endoscope with Fixed Eye Piece	 	Page 5 of 8

 STORAGE & TRAY LOADING 

Storage of the Flexible Endoscope with Fixed Eye Piece can be conducted In several ways. First, adherence to all standard operating procedures
and guidelines of the clinical site must be followed. The following recommendations may be followed for storage of the Flexible Endoscope with Fixed Eye Piece if it does not conflict with internal procedural site standards. 

 

	 	•	 	It is recommended that the endoscope be stored in its own separate container. Interaction with other Instruments may cause damage to the endoscope and reduce the useful lifespan. 

 

	 	•	 	Obtain a container capable of storing the scope in a configuration that does not exceed the minimum bending radius specified In the Warnings section. It is recommended to use a storage container approved by Entellus
Medical Inc. 

  

	 	•	 	Lay the endoscope Into the container first by the endoscope body and then by the flexible segment. The endoscope body should be secured within the tray either by tying it to the tray or using securing inserts that are
compatible with the endoscope. 

 ACCESSORIES 

The Flexible Endoscope with Fixed Eye Piece is packaged with 2 light post adapters. Retain the light post adapters with the endoscope for use
with various configuration light cables (i.e. ACMI, Wolf, Storz, Olympus). 
 IMAGING ENHANCEMENT 

Equipment Recommendations 

For optimum visual performance, use the endoscope with a xenon light source greater than 150W, a light cable with an illumination fiber bundle
less than 5mm in diameter, a high definition camera system, and a 319” display. High definition camera systems with image enhancement options (i.e. – gain, zoom adjustment) are preferred for
optimum viewing and can potentially compensate for lower quality Imaging. For options on enhancing the projected Image refer to the IFU’s supplied with camera, light source and display. 

WARRANTY ASSESSMENT / RETURN FOR SERVICE 

If an endoscope becomes damaged or falls to project an image take the following actions to have the scope assessed for warranty coverage or
replacement. 
 Contact Customer Service. Describe malfunction. 

Phone: (866) 620-7615 
 Fax:
(866) 620-7616 
 If returning devices for assessment all products must be disinfected or sterilized prior to shipping per one of the
approved methods described within this document. Documentation must be provided stating the devices have been reprocessed prior to shipping. 

  

					
	1545-001rC January 2011	 	Flexible Endoscope with Fixed Eye Piece	 	Page 6 of 8

 Limited Warranty 

Entellus Medical, Inc. warrants that reasonable care has been used in the design and manufacture of the Entellus Medical Flexible Endoscope with Fixed Eye
Piece. This limited warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether expressed or implied, written or oral, by operation of law or otherwise Including, but not limited to, any Implied warranties of
merchantability or fitness for a particular purpose, or warranties arising from a course of dealing or usage or trade. Handling, storage, cleaning and sterilization of the Entellus Medical Flexible Endoscope with Fixed Eye Piece, as well as other
factors relating to the patient, diagnosis, treatment, medical procedures, and other matters beyond Entellus Medical, Inc.’s control, directly affect the Entellus Medical Flexible Endoscope with Fixed Eye Piece and the results obtained from its
use. This limited warranty does not extend to any abuse or misuse of the Entellus Medical Flexible Endoscope with Fixed Eye Piece (including, without limitation, off-label use), accident to or neglect of the Entellus Medical Flexible Endoscope
with Fixed Eye Piece, failure to follow any Instructions or specifications provided with the Entellus Medical Flexible Endoscope with Fixed Eye Piece (including, without limitation, any re-use, re-processing or re-sterilization of the Entellus
Medical Flexible Endoscope with Fixed Eye Piece not in accordance with such Instructions or specifications), in each case whether caused or carried out by Customer or by any third party. 

Entellus Medical’s obligation under this limited warranty is limited, at Entellus Medical Inc.’s option, to the repair or replacement of the
Entellus Medical Flexible Endoscope with Fixed Eye Piece for a period of twelve (12) months from the date of purchase (the “Warranty Period”) using commercially reasonable efforts within a reasonable period of time.
Entellus Medical, Inc. shall not be liable for any incidental or consequential loss, damage or expense directly or Indirectly arising from use of the Entellus Medical Flexible Endoscope with Fixed Eye Piece. Repair or replacement of the Entellus
Medical Flexible Endoscope with Fixed Eye Piece shall not extend the term of any applicable warranty and the original term of such warranty shall remain in effect. Repairs, modifications or alterations of the Entellus Medical Flexible Endoscope with
Fixed Eye Piece performed by any person or entity other than Entellus Medical, Inc. or approved by Entellus Medical Inc. in writing shall nullify and otherwise void all applicable warranties hereunder. 

Entellus Medical, Inc. shall be obligated to honor the express limited warranties contained herein only upon receipt of full payment for the Entellus Medical
Flexible Endoscope with Fixed Eye Piece or otherwise in accordance with the payment terms agreed to by Entellus Medical, Inc. and Customer. 
 Entellus
Medical Inc. neither assumes, nor authorizes any other person to assume for It, any other or additional liability or responsibility in connection with the Entellus Medical Flexible Endoscope with Fixed Eye Piece. 

Limitation of Liability 
 In no event will either Entellus
Medical Inc. or Customer be liable to the other or to any third party for loss of profit, goodwill or other indirect, incidental, special or consequential or other similar damages arising out of these Terms and Conditions or any Related Purchase
Document. The limitation of liability described in this section is in addition to any limitation provided for by the Limited Warranty provisions. 

  

					
	1545-001rC January 2011	 	Flexible Endoscope with Fixed Eye Piece	 	Page 7 of 8

 Symbols 
  

 
  
 

 
 U.S. and Foreign patents pending. 

  

					
	1545-001rC January 2011	 	Flexible Endoscope with Fixed Eye Piece	 	Page 8 of 8

 Exhibit 3 

  
 

 

 Exhibit 4 

  
 

 

 Exhibit 5 

  
 

 
 Entellus Medical Functional INfundibular Endoscopic Sinus System. 

INSTRUCTIONS FOR USE 
 ALL
INSTRUCTIONS, PRECAUTIONS AND WARNINGS SHOULD BE CAREFULLY 
 READ AND UNDERSTOOD BEFORE USE. FAILURE TO DO SO MAY RESULT IN 

COMPLICATIONS. 
 All packaging and
referenced Entellus Medical device components 
 are LATEX FREE 

Caution – Federal (USA) law restricts this device to sale by or on the order of a physician. 

 System Description 

The Entellus Medical, Inc. Functional INfundibular Endoscopic Sinus System (FinESS®) includes the following components: 
 Micro-Trocar, Access Sheath & Access Sheath Spacer

 The Micro-Trocar provides a small access hole into the Maxillary Sinus through the Canine Fossa. The Micro-Trocar also delivers the Access Sheath,
which is intended to maintain consistent access for procedural devices (FinESS® Endoscope & Balloon Catheter) and to position the
FinESS® Endoscope. The Access Sheath Spacer can be removed from the Access Sheath to allow the FinESS® Endoscope to be re-positioned.

  
  
 

 
 Figure 1 – Sinus Access Tools: Micro-Trocar Inserted Through Access Sheath and Access Sheath Spacer 

Baloon Catheter 
 The Balloon Catheter is designed to
dilate the maxillary sinus ostium and the ethmoid infundibulum space. The balloon catheter includes a braided shaft design that allows for rotational positioning to accurately deliver the balloon into the ostium while navigating within the parasinus
space. 
  
  
 

 
 Figure 2 – Sinus Balloon Dilatation Catheter 

Inflation Device 
 The disposable Entellus Medical, Inc.
Inflation Device consists of a syringe barrel, a plunger rod assembly used to generate and control balloon inflation pressures, and a pressure limit mechanism. The pressure limit mechanism limits the amount of positive pressure the Inflation Device
can generate to 12 atm +1 atm (176 psi + 14.7 psi). 
  
  

 
 Figure 3 – Inflation Device 

  

					
	1108-004 Rev C May 2010	 	FinESS® Sinus Treatment	 	Page 2 of 11

 Extension Line 

The Extension Line may be connected to the Inflation Device to provide extra length to maneuver the balloon if necessary. 

 
  
 

 
 Figure 4 – Infusion Line 

All components of the FinESS® Sinus Treatment are provided sterile. 

Indication for Use 
 To access and treat the maxillary sinus
ostium and the ethmoid infundibulum in adults with a trans-antral approach. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinus structures. 

Contraindications 
 Patients with thickened polypoid mucosa
excessive enough to inhibit the visualization of the maxillary ostium should not be considered candidates for the FinESS® Sinus Treatment. 

Warnings 
  

	 	•	 	Only physicians possessing sufficient skill and expertise in similar technique (accessing maxillary sinus ostium and ethmoid infundibulum through canine fossa) should perform this procedure. 

 

	 	•	 	Do not use the FinESS® Sinus Treatment if CT image indicates challenging anatomy such as a hypoplastic antrum or polypoid mucosa that may limit success of Canine
Fossa approach. 

  

	 	•	 	Do not use opened or damaged packages . 

  

	 	•	 	The FinESS® Sinus Treatment is intended for single procedure use only. Do not attempt to reuse or re-sterilize. Device integrity may be compromised.

  

	 	•	 	Do not apply excessive penetration force when drilling the canine fossa access hole. Patient injury or device damage may occur. 

  

					
	1108-004 Rev C May 2010	 	FinESS® Sinus Treatment	 	Page 3 of 11

	 	•	 	Do not exceed the maximum recommended balloon inflation pressure (12 atm). Use of the Entellus Medical Inflation Device is required to prevent over-pressurization. 

 

	 	•	 	Do not advance or withdraw the Balloon when inflated. Mucosa damage or device damage may occur. 

  

	 	•	 	As in any upper airway procedure or sinus surgery, do not use CPAP until the physician has confirmed that the tissue is adequately healed. CPAP usage prior to soft tissue healing may result in facial and/or neck
swelling due to subcutaneous emphysema. 

 Precautions 
  

	 	•	 	FinESS® Sinus Treatment components should be stored in a cool and dry place. Never use a device that is beyond its expiration date. 

 

	 	•	 	FinESS® Sinus Treatment components should be handled with care. Prior to use, and during the procedure, inspect the packaging and components for bends, kinks, or
other damage. Discontinue the use of any component that may have been damaged. 

  

	 	•	 	Pay special attention when advancing or withdrawing the Endoscope or Balloon Catheter. Never advance, withdraw or torque any component that meets resistance, as this could cause kinking or breaking. If resistance is
encountered, use endoscopy to help guide device manipulation. If the cause of resistance cannot be determined, withdraw all components as a system. 

  

	 	•	 	The Balloon Catheter should only be manipulated under endoscopic observation. 

  

	 	•	 	Patients should be advised to sneeze with an open mouth and avoid extreme inhalation and blowing through the nose for approximately 7 days post-procedure to reduce the likelihood of inflammation and/or swelling due to
subcutaneous emphysema. 

  

	 	•	 	It is important to review the patient’s CT image prior to performing the FinESS® procedure in order to determine the most appropriate access location and to
appreciate unique anatomical characteristics, eg. agger nasi cell, that may impact placement of the balloon into the desired treatment location. 

Adverse Effects 
 Possible adverse effects include, but are not
limited to, the following: 
  

	 	•	 	Post-operative facial pain 

  

	 	•	 	Excessive bleeding in the nose and at the canine fossa 

  

	 	•	 	Complication from anesthesia 

  

	 	•	 	Fracture of the anterior wall of the maxillary sinus 

  

	 	•	 	Cerebrospinal fluid leak 

  

	 	•	 	Loss of vision or diplopia (double vision) 

  

	 	•	 	Damage to a tooth root or gingiva 

  

	 	•	 	Damage to nerves potentially causing temporary (and occasionally prolonged) numbness to the cheek, lip, or teeth; mid-facial pain; and tooth pain or hypersensitivity 

 

	 	•	 	Facial bruising and swelling 

  

	 	•	 	Swelling of the nose and cheek 

  

	 	•	 	Fever and infection 

  

	 	•	 	Tissue inflammation 

  

	 	•	 	Continued or worsening sinus symptoms 

 Supplies 

The following supplies need to be available and prepped prior to use of the FinESS® Sinus Treatment.

 Note: These supplies are not provided with the FinESS® Sinus Treatment. 

 

	 	•	 	FinESS® Endoscope and compatible camera system 

  

	 	•	 	Sterile Saline Solution 

  

					
	1108-004 Rev C May 2010	 	FinESS® Sinus Treatment	 	Page 4 of 11

	 	•	 	60 cc Syringe (if irrigation is to be performed) 

  

	 	•	 	Needles and Syringes as required for local anesthesia injections 

  

	 	•	 	Suction system 

  

	 	•	 	#5 and #7 Suction Tips 

  

	 	•	 	Other supplies or medication as per established laboratory protocol 

 System Preparation 

 

	1.	Prepare the FinESS® Endoscope. 

  

	 	a.	Verify endoscope has been disinfected per appropriate instructions. 

  

	 	b.	Connect the FinESS® Endoscope to an appropriate light source and cameras specified in the FinESS®
Endoscope instructions for use. 

  

	 	c.	While holding the FinESS® Endoscope, rotate the Camera relative to the eyepiece to align the image as desired. 

 

	2.	Prepare Micro-Trocar. 

  

	 	a.	Remove the Micro-Trocar and Access Sheath from their sterile package. 

  

	3a.	Prepare Inflation Device (to prepare the Inflation Device with provided Infusion Line, proceed to step 3b) 

  

	 	a.	Remove the Inflation Device from its sterile package. 

  

	 	b.	Depress the plunger rod fully into the body of the Inflation Device. 

  

	 	c.	Insert the luer end of the Inflation Device into Sterile Saline Solution. Fully retract the plunger rod to the stop position (2nd Detent) as shown in Figure 6. This will fill the barrel with saline solution.

  

	 	d.	While holding the Inflation Device with the luer pointed up, advance the plunger rod into the syringe barrel one click to the position shown in Figure 6 to purge air. The Inflation Device is now ready to be connected to
the balloon. 

 Note: Inspect the syringe barrel to ensure there is minimal air in the system. If excessive air remains in
the system, repeat steps b – d. 
  
  
 

 
 Figure 6 
  

	3b.	Prepare Inflation Device with Infusion Line. 

  

	 	a.	Remove the Inflation Device and the Infusion Line from the sterile package. 

  

					
	1108-004 Rev C May 2010	 	FinESS® Sinus Treatment	 	Page 5 of 11

	 	b.	Connect the Infusion Line to the Inflation Device. 

  

	 	c.	Insert the luer fitting of the Infusion Line into sterile saline solution. Keep the Inflation Device luer pointed up during the prepping steps to prevent air entrapment. 

 

	 	d.	Fully retract the plunger rod to the stop position (2nd Detent) as shown in Figure 6. This will fill the barrel with the saline solution. 

 

	 	e.	Advance the plunger rod fully into the syringe barrel to purge air from the system. 

  

	 	f.	Repeat steps d and e until no more air is present in the system. 

  

	 	g.	With the balloon device full of saline and the plunger fully retracted (to stop position}, advance the plunger to the first detent (Figure 6). The Inflation device is now ready to be connected to the balloon.

 Note: Inspect the syringe barrel to ensure there is minimal air in the system. If excessive air remains in the system,
repeat steps d – e. 
  

	4.	Prepare Balloon Catheter 

  

	 	a.	Remove the Balloon Catheter from its sterile package. 

  

	 	b.	Connect the Balloon Catheter to the Inflation Device (or Infusion Line, if applicable). 

  

	 	c.	While holding the Inflation Device with the Balloon Catheter pointed down, depress the plunger rod with 2 hands, keeping the plunger rod straight, until the distal seal on the orange piston aligns with the distal mark
on the inflation device. 

  

	 	d.	Pull back on the plunger rod to the stop (2nd detent) position to apply a vacuum to the balloon. 

 

	 	e.	Remove the balloon protector from the Balloon. Retain the balloon protector for balloon re-wrapping. 

 System
Operation 
  

	1.	Patient preparation. 

  

	 	a.	Patient preparation should be consistent with standard practice. 

  

	 	b.	Anesthesia should be administered appropriately to allow patient tolerance. 

  

	2.	Access Maxillary Sinus 

  

	 	a.	Firmly lift and retract lip to visualize gingival tissue and feel for canine fossa recess. 

  

	 	b.	While retracting lip to minimize gingival tissue thickness, enter tissue with Micro-Trocar. 

  

	 	c.	After accessing gingival tissue, position Micro-Trocar tip on bony surface at the intersection location described in Figure 7. 

  

	 	Note:	The target access location is typically on the lateral side of the canine fossa recess. 

  

	 	Note:	Access location may be confirmed by gently angling the Micro-Trocar to be perpendicular to the facial plane while holding the Micro-Trocar tip on the bone at the target access location. 

 

	 	d.	While holding Micro-Trocar at appropriate angle (approximately 45 degrees from the facial plane with the Micro-Trocar tip pointed at the inside corner of the eye}, apply a back-and-forth rotational motion (versus a
pushing motion) to gently create an access hole. 

  

	 	Note:	Do not apply excessive penetration force when making access hole. 

  

					
	1108-004 Rev C May 2010	 	FinESS® Sinus Treatment	 	Page 6 of 11

  
 

 
 Figure 7 – Target Access Site Location 

 

	 	e.	After sinus access is achieved, continue rotating Micro-Trocar with back-and-forth motion while gently angling the Micro-Trocar tip toward the Maxillary Sinus Ostium (corner of the eye). The gentle side-cutting motion
provides a range of motion for the FinESS® Endoscope to visualize the Sinus Ostium. 

  

	 	Note:	The Micro-Trocar must be rotated with a back-and-forth motion prior to angling the Micro-Trocar. 

  

	 	Note:	The Micro-Trocar Pin must be engaged with the Access Sheath to allow side-cutting. If Micro-Trocar pulls out of Access Sheath, re-insert and continue Micro-Trocar rotations.

  

	 	f.	While holding Access Sheath in access site with one hand, slide the Micro-Trocar out of the Access Sheath with the other hand by using thumb to push the Access Sheath off of the Micro-Trocar. Do not apply downward force
with the Micro-Trocar during removal. 

  

	 	Note:	If Access Sheath slips out of access site (even if it Is just removed from the hole in the bone) at any time, re-load Access Sheath onto Micro-Trocar and use Micro-Trocar to locate original hole, or to
re-access in a secondary location. Do not attempt to re-access the hole with the Access Sheath only. Access Sheath damage may occur. 

  

	 	g.	Use a standard #5 suction tip to aspirate fluid from the access sheath as required. 

  

	3.	While holding the FinESS® Endoscope in an upright position insert the FinESS® Endoscope into Access
Sheath under endoscopic visualization. 

  

	 	Note:	The FinESS® Endoscope should be inserted the Access Sheath until the Endoscope is seated against the Access Sheath Spacer (see Figure 1). Failure to accurately
position the Endoscope may result In balloon damage. 

  

	 	Note:	The Access Sheath Spacer may be removed from the Access Sheath to allow additional Endoscope insertion depth if necessary. The FinESS®
Endoscope should be inserted until the Endoscope is seated against the Access Sheath (see Figure 1). Failure to accurately position the Endoscope may result in balloon damage. 

 

	 	Note:	At any time during the procedure, the Endoscope may be removed from the Access Sheath to clean the Endoscope by gently wiping the Endoscope tip across an alcohol prep pad or anti-fog cleaning pad.

  

	4.	Visualize presence of air / fluid level within sinus. 

  

	 	a.	If fluid level impedes endoscopic visualization, aspiration and/or irrigation may be required. 

  

					
	1108-004 Rev C May 2010	 	FinESS® Sinus Treatment	 	Page 7 of 11

	 	b.	To Irrigate, fill a 60 cc syringe with Sterile Saline Solution and purge air. Connect the syringe to the FinESS® Endoscope balloon port and flush with saline.

  

	 	c.	Verify acceptable fluid level. Excess residual saline in the sinus should be gently aspirated through a standard #5 suction device. 

  

	5.	Visualize the maxillary sinus ostium. 

  

	 	a.	While holding the Access Sheath in the access site, gently manipulate the Endoscope to visualize the maxillary sinus ostium. 

  

	 	b.	While visualizing the ostium, topical anesthetic may be sprayed through the Endoscope for additional topical anesthesia as required. 

 

	 	Note:	Use suction to remove residual anesthetic from Endoscope using either a standard #5 tip or connecting the suction to directly to the balloon port of the Endoscope. 

 

	6.	Introduce the Balloon Catheter through the FinESS® Endoscope. 

  

	 	Note:	The Balloon Catheter should be tracked through the FinESS® Endoscope while under vacuum from the Inflation Device. 

 

	7.	Advance the Balloon across the ostium under endoscopic visualization. 

  

	 	a.	When the Balloon Catheter tip is positioned just outside of the ostium, advance the balloon into the sinus ostium with the curved catheter tip pointed posterior / inferior. 

Note: The arrow on the Balloon Catheter hub indicates the direction of the tip curve. 

 

	 	b.	Using the Shaft Marker (see Figure 3) as a visual reference for the proximal balloon end, position the Balloon within the ostium / infundibulum. 

Note: The Balloon Catheter may be rotationally steered to allow full insertion of the balloon into the ostium and infundibulum. 

 

	8	Inflate Balloon. 

  

	 	a.	Slowly depress the plunger rod with 2 hands, keeping the plunger rod straight, to inflate the balloon. The pressure should be increased slowly (3 – 5 seconds) until the distal seal on the orange piston reaches the
distal mark on the inflation device. 

  

	 	Note:	Do not use air or any gaseous medium to inflate the balloon. 

  

	 	b.	Inflate sinus balloon until desired result is achieved. Endoscopically observe balloon dilation. 

  

	 	Note:	Do not exceed the maximum pressure of 12 atm. 

  

	 	c.	After balloon dilation is complete, deflate the sinus balloon by gently pulling back on the plunger rod. Confirm the balloon deflation endoscopically. 

 

	 	d.	Lock the plunger rod in place by pulling it back to the stop position. The stop will prevent the plunger rod form being removed from the inflation device. 

 

	 	e.	Verify the FinESS® Endoscope Is seated against the Access Sheath Spacer or Access Sheath to ensure the Endoscope tip is inserted beyond the Access Sheath.

  

	 	f.	Withdraw balloon from Endoscope under endoscopic visualization. 

  

	 	Note:	Rotating the Catheter as the Balloon begins to engage the Endoscope will assist in balloon withdrawal. 

  

	9.	Endoscopically observe balloon dilation result. 

  

	 	a.	If the maxillary sinus ostium has been adequately dilated, remove Endoscope and Access Sheath from access site. 

  

	 	Note:	Adequate dilation can be visually confirmed by observing the balloon during Inflation, visually verifying balloon positioning during inflation, and ensuring that the recommended Inflation pressure is achieved.

  

					
	1108-004 Rev C May 2010	 	FinESS® Sinus Treatment	 	Page 8 of 11

	 	b.	If additional balloon dilation is required, prepare Balloon Catheter per step 10 and repeat steps for Balloon inflation. 

  

	10.	Prepare Balloon Catheter for additional dilations (if required). 

  

	 	a.	Gently advance the plunger rod into the syringe barrel to expand the balloon using minimal pressure. 

  

	 	b.	Rinse balloon with sterile saline or water. 

  

	 	c.	Wipe balloon dry using gauze pad. 

  

	 	d.	Point the distal tip of the balloon catheter down. Gently pull back on the plunger rod to apply vacuum to the balloon. Lock the plunger rod by pulling it back to the stop position. 

 

	 	e.	Re-wrap the tri-folded balloon by gently folding the wings around the catheter shaft in a clockwise direction. 

  

	11.	Repeat procedure for contralateral maxillary sinus if needed. 

  

	12.	After completing the entire procedure, withdraw all system components. Discard FinESS® Sinus Treatment System components and set FinESS® Endoscope aside for reprocessing. 

  

					
	1108-004 Rev C May 2010	 	FinESS® Sinus Treatment	 	Page 9 of 11

 Limited Warranty 

Entellus Medical, Inc. warrants that reasonable care has been used in the design and manufacture of the
FinESS® Sinus Treatment system. This limited warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether expressed or implied, written or oral, by
operation of law or otherwise including, but not limited to, any implied warranties of merchantability or fitness for a particular purpose, or warranties arising from a course of dealing or usage or trade. Handling, storage, cleaning and
sterilization of the FinESS® Sinus Treatment system, as well as other factors relating to the patient, diagnosis, treatment, medical procedures, and other matters beyond Entellus Medical,
Inc.’s control, directly affect the FinESS® Sinus Treatment system and the results obtained from its use. This limited warranty does not extend to any abuse or misuse of the FinESS® Sinus Treatment system (including, without limitation, off-label use), accident to or neglect of the FinESS® Sinus Treatment system,
failure to follow any instructions or specifications provided with the FinESS® Sinus Treatment system (including, without limitation, any re-use, re-processing or re-sterilization of the
FinESS® Sinus Treatment system not in accordance with such instructions or specifications), in each case whether caused or carried out by Customer or by any third party. 

Entellus Medical’s obligation under this limited warranty is limited, at Entellus Medical, Inc.’s option, to the repair or replacement of the FinESS® Sinus Treatment system for a period of twelve (12) months from the date of purchase (the “Warranty Period”) using commercially reasonable efforts within a reasonable period
of time. Entellus Medical, Inc. shall not be liable for any incidental or consequential loss, damage or expense directly or indirectly arising from use of the FinESS® Sinus Treatment system.
Repair or replacement of the FinESS® Sinus Treatment system shall not extend the term of any applicable warranty and the original term of such warranty shall remain in effect. Repairs,
modifications or alterations of the FinESS® Sinus Treatment system performed by any person or entity other than Entellus Medical, Inc. or approved by Entellus Medical, Inc. in writing shall
nullify and otherwise void all applicable warranties hereunder. 
 Entellus Medical, Inc. shall be obligated to honor the express limited warranties
contained herein only upon receipt of full payment for the FinESS® Sinus Treatment system or otherwise in accordance with the payment terms agreed to by Entellus Medical, Inc. and Customer.

 Entellus Medical, Inc. neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in
connection with the FinESS® Sinus Treatment system. 
 Limitation of Liability 

In no event will either Entellus Medical, Inc. or Customer be liable to the other or to any third party for loss of profit, goodwill or other Indirect,
incidental, special or consequential or other similar damages arising out of these Terms and Conditions or any Related Purchase Document. The limitation of liability described in this section is in addition to any limitation provided for by the
Limited Warranty provisions. 

  

					
	1108-004 Rev C May 2010	 	FinESS® Sinus Treatment	 	Page 10 of 11

 Symbols 
  

 
 

 
 This product is protected by US Patent No. 7,520,876. Other US Patents Pending. 

©2009 Entellus Medical. All rights reserved. FinESS is a registered trademark of
Entellus Medical. 
  
 

 

  

					
	1108-004 Rev C May 2010	 	FinESS® Sinus Treatment	 	Page 11 of 11

 Exhibit 6 

  
 

 
 FinESSTM Endoscope 

(3.2mm 0°) 
 INSTRUCTIONS FOR
USE 
 ALL INSTRUCTIONS, PRECAUTIONS AND WARNINGS SHOULD BE CAREFULLY READ AND UNDERSTOOD 

BEFORE USE. FAILURE TO DO SO MAY RESULT IN COMPLICATIONS AND WILL VOID ANY EFFECTIVE 

WARRANTY. 
 Caution: Federal (USA) law
restricts this device to sale by or on the order of a physician. 
 DESCRIPTION 

The Entellus Medical FinESS Endoscope has the following features: 
  

	 	•	 	The FinESS Endoscope has a 3.2mm outer diameter, a 0° direction of view, and a 1.75mm internal diameter working channel. 

  

	 	•	 	The working length of the endoscope is 60mm 

  

	 	•	 	The Eye Cup of the endoscope is compatible with standard “B” mount camera couplers. 

  

	 	•	 	The endoscope is compatible with standard light cables and adapters 

  

 
 

 
 INDICATION FOR USE 
 The
FinESS Endoscope is intended to provide a means to visualize the maxillary sinus cavity and deliver the FinESS balloon dilation catheter to treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. 

CONTRAINDICATIONS 
 The use of endoscopes is not permissible in
situations where endoscopic procedures are contraindicated for medical reasons. 
 WARNINGS 

 

	 	•	 	The FinESS Endoscope is provided NON-STERILE and must be sterilized or high level disinfected prior to its first use and every subsequent use (see Care & Handling, Cleaning, High Level Disinfection, and
Sterilization Instructions sections). Cleaning, Disinfection, and Sterilization of this product must be performed by staff skilled in the reprocessing of medical devices following the directions and guidelines provided. Refer to
http://www.cdc.gov/ncidod/dhqp/bp_sterilization_medDevices.html for the CDC document titled “Sterilization or Disinfection for Medical Devices” for general information about preventing the spread of infection for reusable devices.

  

					
	1577-001-Draft2 Jan 13 2011	 	FinESS Endoscope	 	Page 1 of 9

 WARNINGS cont. 
  

	 	•	 	Do not sterilize the FinESS Endoscope in an autoclave or other types of steam sterilization. Exposure to temperatures greater than 65°C (150°F) may damage the device. 

 

	 	•	 	Do not clean the FinESS Endoscope with ultrasonic cleaning. Ultrasonic cleaning can permanently damage the endoscope lenses and fiber optic components. 

 

	 	•	 	Do not use an endoscope disinfected with CIDEX® OPA on patients with CIDEX OPA sensitivity. 

 

	 	•	 	Do not use a FinESS Endoscope that has been damaged. Use of equipment that is not in good working condition may compromise patient safety. 

 

	 	•	 	Do not use reprocessing chemicals or channel cleaning instruments that are not specified in these instructions for use. Use of these chemicals or channel cleaning instruments may result in damage to the endoscope or may
reduce the effectiveness of the disinfection or sterilization process. 

  

	 	•	 	Do not use the FinESS Endoscope with a xenon light source > 300W or a light guide (cable) > 5mm in diameter. High energy light radiated through endoscopes can result in high temperatures in front of the light
outlet and at the connection point with the light cable, including the light guide adapters. Use of a higher wattage light source or larger diameter cable may result in bums or permanent tissue damage to the user or the patient. 

 

	 	•	 	Allow the endoscope system to cool for a few minutes before disassembling the endoscope from the light guide adapter and light guide cable. 

PRECAUTIONS 
  

	 	•	 	Clean and disinfect or clean and sterilize the FinESS Endoscope prior to its first use and every subsequent use per the included Cleaning, Disinfection and Sterilization Instructions. If high level disinfection is the
method chosen, this step must be performed immediately prior to use on a patient. 

  

	 	•	 	Observe the exposure times discussed in the Cleaning and Disinfection sections. The FinESS Endoscope may become slightly discolored by over-exposure to ENZOL®
Enzymatic Detergent (if soaked longer than 8 hours) or CIDEX OP A Solution (if soaked longer than 7 days). The potential discoloration will not alter the function of the instrument. 

 

	 	•	 	Inspect the FinESS Endoscope prior to each use for signs of wear and tear, damage, or failed or degraded image quality. Discontinue the use of an endoscope with severe bends, signs of corrosion, mechanical damage to the
optical components at the tip, degraded or cloudy image quality or a complete loss of image. These devices should not be used and should be sent to the manufacturer for replacement, disposal, or repair. Consult the Return for Service section of this
document for customer service contact information. 

  

	 	•	 	Use only non- or semi-abrasive instruments (FinESS balloon dilation catheter and cleaning brushes) that fit within the 1.75 mm working channel of the FinESS Endoscope. Sharp or abrasive metal instruments may damage the
working channel of the endoscope. 

  

	 	•	 	Only use cleaning brushes listed in the Recommended Supplies section. Use of other brushes has not been tested and may damage device. 

  

					
	1577-001-Draft2 Jan 13 2011	 	FinESS Endoscope	 	Page 2 of 9

 PRECAUTIONS cont. 
  

	 	•	 	Use solutions that are non corrosive to surgical stainless steel in the working channel. This includes 70% isopropyl alcohol, Enzol enzymatic detergent, Cidex OPA disinfectant and STERRAD processing agents.

  

	 	•	 	Connect the FinESS Endoscope to a camera prior to each use to ensure the FinESS Endoscope projects an acceptable image. A cloudy image is a sign that a leak may have occurred in the endoscope. 

 

	 	•	 	Do not use the FinESS Endoscope with an endo sheath. 

  

	 	•	 	If the FinESS endoscope is dropped, contact a representative to assess if the endoscope is acceptable for use. Alternatively, return the endoscope to Entellus Medical for assessment using the guidance provided in the
Return for Service section. 

  

	 	•	 	Do not hang the FinESS Endoscope in a storage cabinet or store in a tray other than the recommended storage tray. 

  

	 	•	 	Do not store the FinESS Endoscope or light post adapters in the foam-lined shipping box between uses because the foam liners can retain microbes. 

RECOMMENDED SUPPLIES 
  

	 	•	 	Sterile water 

  

	 	•	 	Sterile gauze pads or sterile disposable cloth 

  

	 	•	 	Sterile Anti fog pads 

  

	 	•	 	ENZOL® detergent for cleaning 

  

	 	•	 	CIDEX® OPA Solution for high level disinfection if desired 

  

	 	•	 	Sterile plastic syringes with a male luer lock or luer slip tip for cleaning and disinfecting 

  

	 	•	 	Disposable 5 mm nylon brush, 3 7 inches long Cat# TR350354, HealthMark Industries for cleaning (or equivalent) 

 

	 	•	 	Syringe with 3 20 mL volume capacity having either a male luer lock or a luer slip tip 

  

	 	•	 	Instrument tray approved for use in the STERRAD® NXTM sterilizer 

  

	 	•	 	FinESS Sinus Treatment 

 Equipment for Imaging Enhancement 

 

	 	•	 	Use a xenon light source with at least 150W but no more than 300W in power. 

  

	 	•	 	Use a light guide (cable) that is at least 3.5 mm but not more than 5mm in diameter. 

  

	 	•	 	A high definition camera system and a 319” display is recommended. High definition camera systems with image enhancement options (i.e. – gain, zoom adjustment) are
preferred for optimum viewing. 

  

	 	•	 	For options on enhancing the projected image refer to the Instructions for Use supplied with camera, light source and display. 

CARE AND HANDLING 
  

	 	•	 	The FinESS Endoscope is constructed with glass fiberoptic and lens components. Special care must be taken to prevent damage to the optics and to maintain optimal functionality and longevity of the endoscope.

  

	 	•	 	 Protect the endoscope system during procedural use and transportation between the procedural room and reprocessing location. A void harmful
interaction with other surgical 

  

					
	1577-001-Draft2 Jan 13 2011	 	FinESS Endoscope	 	Page 3 of 9

	 	 
instruments or tools. The FinESS Endoscope contains glass optics that may be damaged if misused. 

  

	 	•	 	Periodically inspect (10X magnification) the lens in the distal tip of the endoscope for signs of mechanical damage such as chipping, pitting, cracks, or nicks. Discontinue use of the endoscope or return to the
manufacturer if damage is noted. 

 COMPATIBILITY 

The FinESS Endoscope is compatible with the FinESS balloon dilation catheter and the FinESS access sheath. Please refer to the FinESS Sinus Treatment
Instructions for Use for detailed information and instructions on the use of the FinESS Sinus Treatment system. The FinESS Endoscope is not compatible with the XprESS Multi Sinus Dilation Tool. 

INSTRUCTIONS FOR USE 
  

	1.	Verify that endoscope has been cleaned and disinfected or cleaned and sterilized. 

  

	2.	Inspect the working lumen of the FinESS Endoscope to assure it is free of obstruction. 

  

	3.	Prior to each use, check the image quality. If the picture is blurry and does not clear using standard cleaning methods, do not use the endoscope and contact Entellus Medical for servicing of the endoscope.

  

	4.	Connect the endoscope to the selected light source and camera using one of the adaptors provided, if necessary. 

  

	5.	The FinESS Endoscope is introduced through the opening of the FinESS access sheath and guided under direct visualization assisted by video system. Please refer to the FinESS Sinus Treatment Instructions for Use for
detailed information and instructions on the use of the FinESS Sinus Treatment system. 

  

	6.	The FinESS balloon dilation catheter is introduced through the FinESS Endoscope working channel. Please refer to the FinESS Sinus Treatment Instructions for Use for detailed information and instructions on the use of
the FinESS Sinus Treatment system. 

  

	Note:	If suction or irrigation is desired during the procedure, remove the FinESS Endoscope from the sinus and perform standard irrigation or suction techniques. 

CLEANING, DISINFECTION, AND STERLILIZATION INSTRUCTIONS 

Pre-Cleaning (Immediately After Use) 
  

	1.	Remove heavy soil from the endoscope by wiping the exterior with a wet (using sterile water) disposable cloth. 

  

	2.	Aspirate sterile water through the working channel until the rinsed solution is visibly free of organic matter (standard suction may be used). If the working channel becomes plugged, use the recommended nylon brush to
clean debris out of the channel. 

  

	3.	Transfer to the cleaning location for further cleaning and reprocessing as soon as possible. 

 Cleaning (Prior
to Disinfection or Sterilization) 
 The FinESS Endoscope must be cleaned with an enzymatic cleaner I detergent (ENZOL® Enzymatic Detergent is recommended) to remove all tissue, materials and debris prior to initial use; immediately after every procedural use; and before disinfection or further reprocessing. 

All instructions provided by the enzymatic detergent manufacturer and provided below must be carefully followed. 

Note: The entire FinESS Endoscope is submersible. 

  

					
	1577-001-Draft2 Jan 13 2011	 	FinESS Endoscope	 	Page 4 of 9

	1.	Wear all manufacturer recommended personal protective clothing / equipment when performing any cleaning procedure. 

  

	2.	Use fresh cleaning solutions for each cleaning. 

  

	3.	Prepare the enzymatic cleaner/detergent following the manufacturer’s instructions (for ENZOL, use 1 ounce/gallon of water; if there is dried on organic soil on endoscope use 2 ounces/gallon and/or warm water.)
Ensure there is sufficient enzymatic solution to fully submerge the endoscope. 

  

	4.	Disconnect the light post adapter(s) from the endoscope (if present) by rotating it counter-clockwise in relation to the endoscope. 

  

	5.	Fully Immerse the endoscope and light post adaptors into the detergent solution. 

  

	 	•	 	While fully submerged, use the recommended syringe to flush the working channel with approximately 20cc of the enzymatic solution and let it soak. 

 

	6.	Soak the endoscope and light post adapters in the enzymatic cleaning solution for the recommended soak time provided by the enzymatic detergent manufacturer. For ENZOL, a minimum soak time of 1 minute is recommended. If
endoscope has dried-on organic matter, extend soak time while performing step 7 below. Total soak time may take approximately 5-6 minutes if endoscope has dried-on organic matter. 

 

	7.	While fully submerged, clean the endoscope and light adaptors, paying close attention to the distal segment and the working channel. 

 

	 	•	 	Wipe the entire external portion of the endoscope and adapters using a cloth or towel while the endoscope and adapters are submerged in the enzymatic detergent solution. Heavily soiled areas can be scrubbed with the
recommended nylon brush. 

  

	 	•	 	Wipe the distal end containing the lenses gently, but thoroughly, with the cloth or towel to remove any contaminants remaining on the endoscope. 

 

	 	•	 	Clean the inner diameter of the working lumen of endoscope and lumen of adapters using the recommended nylon brush. While the endoscope is submerged, insert the brush through the hub of the endoscope and advance it
until the bristles of the brush extend out past the distal end of the endoscope. Remove any visible debris from the brush and pull back through the working lumen until completely removed. Clean any residual debris from the brush between passes
through the lumen. 

  
  
 

 
 Note: The pictures are for illustration only. Brushing should be done with the endoscope fully submerged.

  

	 	•	 	Repeat the brushing of the working lumen until no visual signs of debris are present on the brush. 

  

	 	•	 	Brush the adapter lumens with a circular motion combined with a back and forth motion until no visible signs of debris are present on the brush. 

 

	8.	Thoroughly rinse the outside of the endoscope and the light adaptors with water and aspirate at least 100cc of water through the lumen. Dionized or de-mineralized water is recommended. 

 

	9.	Dry the devices using low pressure, filtered air. Purge the working lumen with air until all visible water is removed. Note: The endoscope can withstand air pressure of up to 70 psi while drying. The endoscope may also
be purged with air using the recommended syringe if house air is not available. 

  

	10.	Manually dry the external portions of the endoscope and adapters with a clean absorbent cloth or towel. 

  

					
	1577-001-Draft2 Jan 13 2011	 	FinESS Endoscope	 	Page 5 of 9

	11.	Discard the enzymatic cleaner and the disposable cleaning brush used on the FinESS Endoscope after a single use. 

  

	12.	Store cleaned endoscope in a clean container or instrument tray capable of securing and isolating the endoscope from other instruments. The container or instrument tray should be oriented with the endoscope vertical
during storage. See “Storage Between Use” section for more details. 

  

	High	Level Disinfection 

 The FinESS Endoscope can be disinfected with the manual high level disinfection process
using the CIDEX® OPA Solution (i.e., 0.55% ortho-phthaldehyde). Follow all instructions provided by the manufacturer of CIDEX OP A Solution when performing the disinfection process.
The recommended temperature for CIDEX OPA Solution is a minimum of 20° C or 68° F. Disinfect scope immediately prior to use. 
 Note: The entire
FinESS Endoscope is submersible. 
  

	1.	Wear all manufacturer recommended personal protective clothing I equipment prior to performing disinfection with CIDEX OPA Solution. 

 

	2.	Add the CIDEX OPA Solution into a compatible disinfection container. Ensure that there is sufficient CIDEX OPA solution to completely submerge the endoscope. 

 

	3.	Confirm that the concentration of the disinfectant meets the minimum effective value using the test strip specified by the manufacturer prior to each use. 

 

	4.	Ensure that the endoscope and light post adapters have undergone a cleaning process with an enzymatic detergent prior to the disinfection. 

 

	5.	Disconnect the light post adaptor(s) from the endoscope (if attached) by rotating it counter-clockwise in relation to the endoscope. 

 

	6.	Fully Immerse the endoscope and light post adaptors into the Cidex OP A Solution. 

  

	 	•	 	While fully submerged, use the recommended syringe to flush the working channel with approximately 20cc of the Cidex OPA Solution and let it soak. 

 

	7.	Soak the endoscope and light post adapters in the Cidex OPA Solution for the minimum time recommended by the manufacturer (at least 12 minutes). The disinfectant should entirely fill the channel to have full contact for
the full 12 minute minimum. 

  

	8.	Rinse the light post adapters and the FinESS Endoscope 

  

	 	•	 	Fully submerse the endoscope and light post adapters in a minimum of 2 gallons of sterile water for at least one minute. 

  

	 	•	 	Flush the working channel with at least 100cc of sterile water using the recommended syringe. 

  

	 	•	 	Remove the endoscope and light post adapters and discard the rinse water. 

  

	9.	Repeat step 8 TWO additional times for a total of 3 rinse cycles using fresh water for each cycle. 

  

	10.	Dry the outside of the device by using low pressure, filtered air or with a sterile wipe or cloth. Note: The endoscope can withstand air pressure of up to 70 psi while drying. 

 

	11.	Flush the working lumen with 70% isopropyl alcohol (IPA) until the IP A can be seen exiting the opposite end of the endoscope. 

  

	12.	Flush the working lumen with low pressure, filtered air (or syringe air) until no liquid can be seen exiting the lumen. 

  

	13.	Remove residual fluid from the lenses of the FinESS Endoscope with a sterile alcohol wipe (if needed). 

  

	14.	Dry the light post adapters and the FinESS Endoscope using a sterile towel or cloth. 

  

					
	1577-001-Draft2 Jan 13 2011	 	FinESS Endoscope	 	Page 6 of 9

 Sterilization 
 The
FinESS Endoscope may be sterilized with the STERRAD® NXTM Advanced Cycle process. Follow all instructions for use provided for the STERRAD NX Advanced Cycle settings by
Advanced Sterilization Products (ASP), Division of Ethicon Inc., a Johnson & Johnson company, to load the sterilization chamber, to sterilize the FinESS Endoscope, to maintain sterility of the FinESS Endoscope and for proper
aseptic presentation to the surgical field. 
 The FinESS Endoscope may be sterilized with the
STERRAD® NXTM Advanced Cycle process. Follow all instructions for use provided for the STERRAD NX Advanced Cycle settings by Advanced Sterilization Products (ASP), Division of Ethicon
Inc., a Johnson & Johnson company, to load the sterilization chamber, to sterilize the FinESS Endoscope, to maintain sterility of the FinESS Endoscope and for proper aseptic presentation to the surgical field. 

 

	 	•	 	Assure that the endoscope and light post adapters have undergone a cleaning process prior to conducting the sterilization process. 

  

	 	•	 	Sterility can only be assured if the instructions provided for performing the STERRAD® process (supplied by Advanced Sterilization Products (ASP®) are followed. 

  

	 	•	 	Only use containment devices approved for use in the STERRAD® NXTM sterilizer. 

 

	 	•	 	Monitor the effectiveness of the sterilization process with a biological indicator approved for use with the STERRAD® NXTM Advanced Cycle. 

The following sterilization supplies were included in the sterilization validation for the FinESS Endoscope: 

 

	 	•	 	STERRAD® Instrument Tray PC 13837 

  

	 	•	 	STERRAD® Silicone Mat PC 99211 

  

	 	•	 	STERRAD® Chemical Indicator Strip PC 14100 

  

	 	•	 	Test Organism: G. stearothermophilus BI coupons and discs 

  

	 	•	 	STERRAD® Sterilization Pouch (Tyvek Pouches) 

 The
STERRAD® NXTM Sterilizer uses a hydrogen peroxide gas plasma sterilization process which is well suited for thermo- sensitive items. In plasma sterilization, it is possible for the
surfaces of aluminum alloys to discolor. The metal, cylindrical portion of the endoscope eye piece is fabricated from anodized aluminum. The potential discoloration to this component will not alter the function of the instrument. 

 

	Note:	There are limits regarding the size, length and material of instruments with lumens which may be sterilized using STERRAD®. Verify the compliance of the endoscope
instrument with the instructions provided for the STERRAD® NXTM Sterilizer. 

HOW SUPPLIED 
 The FinESS Endoscope is supplied non-sterile and
must be sterilized before its first and every subsequent use. The items packaged with the FinESS Endoscope include the Instructions for Use and 2light post adapters. Retain the light post adapters with the endoscope for use with various
configuration light cables (i.e. ACMI, Wolf, Storz, Olympus). 
 STORAGE BETWEEN USE 

Do not hang the FinESS Endoscope in a storage cabinet or store in a tray other than the recommended storage tray. 

Adhere to the following for the storage of the FinESS Endoscope after cleaning: 
  

	 	•	 	Store individual endoscopes in separate clean containers. Interaction with other instruments may cause damage to the endoscope and reduce the useful lifespan. Any general instrument tray capable of securing and
isolating the FinESS Endoscope from other instruments may be used to store the scope. The container or instrument tray should be oriented with the endoscope vertical during storage. 

  

					
	1577-001-Draft2 Jan 13 2011	 	FinESS Endoscope	 	Page 7 of 9

	 	•	 	If a dirty endoscope (un-cleaned) was accidently stored in the instrument tray, or the tray is visibly dirty, clean and disinfect or clean and steam sterilize the tray before further use. 

If high level disinfection is the method chosen, the step should be performed immediately prior to use on the patient. Storage in a tray does not
maintain the level of disinfection. Thus, a high level disinfected endoscope placed into a clean tray, must be reprocessed again before use on a patient. 

If sterilization by the STERRAD NX process is chosen, follow the Sterrad instructions to maintain sterility of the endoscope between uses. Use a reprocessing
tray for storing and sterilizing the FinESS Endoscope that complies with the STERRAD process and instructions. 
 WARRANTY ASSESSMENT / RETURN FOR SERVICE

 If an endoscope becomes damaged or fails to project an image take the following actions to have the scope assessed for warranty coverage or replacement.

 Contact Customer Service. Describe malfunction. 

Phone: (866) 620-7615 
 Fax:
(866) 620-7616 
 If returning devices for assessment all products must be cleaned and either disinfected or sterilized prior to shipping per one of
the approved methods described within this document. Documentation must be provided stating the device has been reprocessed prior to shipping. 
 Limited
Warranty 
 Entellus Medical, Inc. warrants that reasonable care has been used in the design and manufacture of the Entellus Medical FinESS Endoscope. This
limited warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether expressed or implied, written or oral, by operation of law or otherwise including, but not limited to, any implied warranties of merchantability
or fitness for a particular purpose, or warranties arising from a course of dealing or usage or trade. Handling, storage, cleaning and disinfection of the Entellus Medical FinESS Endoscope, as well as other factors relating to the patient,
diagnosis, treatment, medical procedures, and other matters beyond Entellus Medical, Inc.’s control, directly affect the Entellus Medical FinESS Endoscope and the results obtained from its use. This limited warranty does not extend to any abuse
or misuse of the Entellus Medical FinESS Endoscope (including, without limitation, off-label use), accident to or neglect of the Entellus Medical FinESS Endoscope, failure to follow any instructions or specifications provided with the Entellus
Medical FinESS Endoscope (including, without limitation, any re-use, re-processing or disinfecting of the Entellus Medical FinESS Endoscope not in accordance with such instructions or specifications), in each case whether caused or carried out by
Customer or by any third party. 
 Entellus Medical’s obligation under this limited warranty is limited, at Entellus Medical Inc.’s option, to the
repair or replacement of the Entellus Medical FinESS Endoscope for a period of twelve (12) months from the date of purchase (the “Warrantv Period”) using commercially reasonable efforts within a reasonable period of time.
Entellus Medical, Inc. shall not be liable for any incidental or consequential loss, damage or expense directly or indirectly arising from use of the Entellus Medical FinESS Endoscope. Repair or replacement of the Entellus Medical FinESS Endoscope
shall not extend the term of any applicable warranty and the original term of such warranty shall remain in effect. Repairs, modifications or alterations of the Entellus Medical FinESS Endoscope performed by any person or entity other than Entellus
Medical, Inc. or approved by Entellus Medical Inc. in writing shall nullify and otherwise void all applicable warranties hereunder. 
 Entellus Medical,
Inc. shall be obligated to honor the express limited warranties contained herein only upon receipt of full payment for the Entellus Medical FinESS Endoscope or otherwise in accordance with the payment terms agreed to by Entellus Medical, Inc. and
Customer. 
 Entellus Medical Inc. neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in
connection with the Entellus Medical FinESS Endoscope. 

  

					
	1577-001-Draft2 Jan 13 2011	 	FinESS Endoscope	 	Page 8 of 9

 Limitation of Liability 

In no event will either Entellus Medical Inc. or Customer be liable to the other or to any third party for loss of profit, goodwill or other indirect,
incidental, special or consequential or other similar damages arising out of these Terms and Conditions or any Related Purchase Document. The limitation of liability described in this section is in addition to any limitation provided for by the
Limited Warranty provisions. 
 Graphic Symbols Contained on Device labeling 
  

 
 

 
     Manufactured for: 

    Entellus Medical Inc. 

    6705 Wedgwood Court North 

    Maple Grove, MN 55311 

    (763) 463-1595 

    www.entellusmedical.com 

    U.S. and Foreign patents pending. 

  

					
	1577-001-Draft2 Jan 13 2011	 	FinESS Endoscope	 	Page 9 of 9

 Exhibit 7 

  
 

 
  
 

 
 Multi-Sinus Dilation Tool 

INSTRUCTIONS FOR USE 
 ALL
INSTRUCTIONS, PRECAUTIONS AND WARNINGS SHOULD BE CAREFULLY 
 READ AND UNDERSTOOD BEFORE USE. FAILURE TO DO SO MAY RESULT IN 

COMPLICATIONS. 
 Please check
annually for updates to these Instructions 
 All packaging and referenced Entellus Medical device components are 

LATEX FREE 
 Caution - Federal
(USA) law restricts this device to sale by or on the order of a physician. 
 IF YOU DESIRE A COMPLIMENTARY HARD COPY OF THESE INSTRUCTIONS,

 PLEASE CALL OUR CUSTOMER SERVICE DEPARTMENT AT 866-620-7615 

OR FAX YOUR REQUEST TO 866-620-7616. 

  

					
	1662-001-rG Oct 2010	 	XprESS Multi-Sinus Dilation Tool	 	Page 1 of 9

 Description 
 The
XprESS Multi-Sinus Dilation Tool is intended to remodel or recreate the sinus outflow tract via trans-nasal balloon dilation. The XprESS device combines features of a curved suction tip and a frontal ostium seeker with the tissue expansion effect of
balloon dilation. The familiar features of this device enable a physician to track the device to the sinus ostium. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses within the same patient.

 The XprESS Multi-Sinus Dilation Tool has been tested to withstand multiple inflations and device tip manipulations (up to 25) in a surgical case wherein
all 6 sinus ostia are being dilated. 
 The XprESS device curved suction tip has a 2 mm atraumatic ball tip with a 1 mm inside diameter. A suction tube may
be connected to the proximal barbed fitting to provide active suction. 
  
 

 
 Figure 1 – XprESS Multi-Sinus Dilation Tool 

The XprESS Multi-Sinus Dilation Tool is provided sterile and for single use only. 

The items packaged with the Xpress Multi-Sinus Dilation Tool include the Inflation Device and the Infusion Line. 

Indication for Use 
 To access and treat the frontal recesses,
sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures. 

Contraindications 
  

	 	•	 	Do not use this XprESS device in patients who are allergic to nickel or barium sulfate. 

  

	 	•	 	Do not attach the XprESS device directly to the CT Image Guidance systems. This may result in inaccurate device positioning. 

Warnings 
  

	 	•	 	Never advance or withdraw the XprESS device against any resistance. Do not use excessive force or torque to advance the XprESS device or balloon / slide assembly when positioned in any paranasal space. Such actions
could lead to tissue trauma, bleeding, or device damage. 

  

	 	•	 	Do not use breached or damaged packages, since the sterility and functionality of the device may be compromised. 

  

	 	•	 	This XprESS device is provided sterile. Do not re-sterilize because device integrity may be compromised. 

  

	 	•	 	The XprESS device, inflation device and other accessories are intended for single procedure use only. Do not attempt to reuse or re-sterilize because the integrity of the XprESS devices may be compromised.

  

					
	1662-001-rG Oct 2010	 	XprESS Multi-Sinus Dilation Tool	 	Page 2 of 9

	 	•	 	Due to the variability of sinus anatomy, review appropriate radiographic imaging (CT scan) prior to treatment. Do not use the XprESS device to treat a hypoplastic/atelectatic maxillary sinus or atelectatic ethmoid
infundibulum. 

  

	 	•	 	Do not exceed the maximum recommended balloon inflation pressure of 12 atm. Over-inflation of sinus balloons can result in serious adverse events. 

 

	 	•	 	Do not use ionic or non-ionic fluoroscopic contrast solution to inflate the balloon in patients with known allergies to contrast media. 

 

	 	•	 	If suction through the XprESS device lumen is used during the procedure, temporarily discontinue suction (disconnect suction hose from device, or clamp suction hose) at the time of balloon inflation. Suction can resume
subsequent to balloon deflation. Using the XprESS device in suction mode while balloon is inflated may result in barometric trauma to sinus tissue which may lead to increased bleeding. 

 

	 	•	 	As in any upper airway procedure or sinus surgery, do not use CPAP until the physician has confirmed that the tissue is adequately healed. CPAP usage prior to soft tissue healing may result in facial and/or neck
swelling due to subcutaneous emphysema. 

  

	 	•	 	Do not clean the XprESS device with anti-microbial agents as the compatibility of the XprESS device with these agents has not been tested. 

 

	 	•	 	The XprESS device has been tested only with the Entellus Inflation Device. Do not use other inflation devices. Use of other inflation devices may result in serious patient injury. 

Precautions 
  

	 	•	 	Store the XprESS device components in a cool and dry place. Never use a device that is beyond its expiration date. 

  

	 	•	 	Handle the XprESS device with care. Prior to use, and during the procedure, inspect the packaging and components for bends, kinks, or other damage. Discontinue the use of the XprESS device if it may have been damaged.

  

	 	•	 	Pay special attention when advancing or withdrawing the balloon and slide assembly. If resistance is encountered, use endoscopy or direct visualization to help guide device out of the paranasal space and then attempt to
alleviate the resistance. If the cause of resistance cannot be determined, do not use the XprESS device. 

  

	 	•	 	Use direct endoscope visualization with or without fluoroscopy to ensure accurate placement of the balloon prior to dilation. If balloon location cannot be verified, the balloon should not be inflated.

  

	 	•	 	Consider using self-limiting radiation exposure equipment when employing fluoroscopy to confirm device placement. Ensure the equipment is calibrated and maintained per the equipment manufacturer’s user manual.

  

	 	•	 	Use techniques for reducing fluoroscopic exposure when using fluoroscopy. Examples are applying pulsed beam settings, increasing target-to-panel distance, utilizing posterior-anterior projection, or using appropriate
lead shield protection. Total fluoroscopy time should be limited to 30 minutes. 

  

	 	•	 	When fluoroscopy is used, minimize radiation dose to the lens of the eye and other proliferating tissues due to the potential of cataract formation or injury to the surrounding tissue. 

 

	 	•	 	Do not advance or withdraw the guidewire through the suction lumen against resistance. This could lead to device damage. 

  

	 	•	 	Use standard larger suction tubes for removal of thick secretions or other materials. 

  

	 	•	 	Fully deflate the balloon and retract the balloon slide assembly before withdrawing the XprESS device from the paranasal sinus space. 

 

	 	•	 	Use liquid contrast or sterile saline solution to inflate the balloon. Use of air will make it difficult to achieve the target inflation pressure. 

  

					
	1662-001-rG Oct 2010	 	XprESS Multi-Sinus Dilation Tool	 	Page 3 of 9

	 	•	 	Consider using a new balloon if cross-contamination between sinuses is a concern. 

 Adverse Effects 

Possible adverse effects include, but are not limited to, the following: 
  

	 	•	 	Complication from anesthesia 

  

	 	•	 	Damage to the lamina papyracea 

  

	 	•	 	Damage of the orbital wall or other structures of the eye 

  

	 	•	 	Cerebrospinal fluid leak 

  

	 	•	 	Loss of vision or diplopia (double vision) 

  

	 	•	 	Temporary or permanent facial / nasal pain 

  

	 	•	 	Epistaxis 

  

	 	•	 	Cavernous sinus syndrome 

  

	 	•	 	Damage to the lacrimal sac affecting tearing 

  

	 	•	 	Pneumocephalus 

  

	 	•	 	Facial bruising and swelling 

  

	 	•	 	Tissue inflammation 

  

	 	•	 	Fever and infection 

  

	 	•	 	Continued or worsening sinus symptoms 

  

	 	•	 	Revision surgery 

 Supplies 

The following supplies need to be available and prepped prior to use of the XprESS Multi-Sinus Dilation Tool. 

Note: These supplies are not provided with the XprESS Multi-Sinus Dilation Tool. 
  

	 	•	 	Appropriate endoscopes and compatible camera system 

  

	 	•	 	>50 cc of sterile saline solution or sterile fluoroscopic contrast solution 

  

	 	•	 	Needles and syringes as required for injections 

  

	 	•	 	Suction system 

  

	 	•	 	Other supplies or medication as per established laboratory protocol 

  

	 	•	 	If the use of a sterile guidewire is desired, the recommended guide wire should be made of metal, sterile, straight or curved, and 0.035 inches in diameter with a minimum length of 50 cm. Examples of guidewires that
meet these requirements include the VigorTM Sinus Guidewire and the Relieva LumaTM Sinus Illumination System guidewire, both available from Acclarent, Inc. 

 

	 	•	 	Bowl containing > 50 cc of sterile saline for prepping the inflation device, infusion line, and inflating the balloon. 

Optional Equipment 
  

	 	•	 	Standard CT image guidance system and tools (Do not attach directly to XprESS device) 

  

	 	•	 	Fluoroscopy may be used in conjunction with the endoscope if desired. 

  

	 	•	 	Refer to appropriate Instructions for Use and safety procedures when preparing and using equipment. 

 System
Preparation 
  

	1.	Prepare Entellus Medical Inflation Device and Infusion Line. 

  

	 	a.	Remove the Inflation Device and the Infusion Line from the sterile package. 

  

	 	b.	Connect the Infusion Line to the Inflation Device. 

  

	 	c.	Insert the luer fitting of the Infusion Line into sterile saline solution. Keep the Inflation Device luer pointed up during the prepping steps to prevent air entrapment. 

 

	 	d.	Fully retract the plunger rod to the stop position (2nd Detent) as shown in Figure 2. This will fill the barrel with the saline solution. 

  

					
	1662-001-rG Oct 2010	 	XprESS Multi-Sinus Dilation Tool	 	Page 4 of 9

	 	e.	Advance the plunger rod fully into the syringe barrel to purge air from the system. 

  

	 	f.	Repeat steps d and e until no more air is present in the system. 

  

	 	g.	With the XprESS device full of saline and the plunger fully retracted (to stop position), advance the plunger to the first detent (Figure 3). The Inflation device is now ready to be connected to the balloon.

  

	Note:	Inspect the syringe barrel to ensure there is minimal air in the system. If excessive air remains in the system, repeat prepping process. 

 
 

 
  

	2.	Prepare XprESS Multi-Sinus Dilation Tool. 

  

	 	a.	Remove the XprESS device from its sterile package. 

  

	 	b.	Connect the prepped Inflation Device Infusion Line to the balloon inflation luer. 

  

	 	c.	Remove and discard the balloon protector prior to introducing the balloon into the sinus. 

  

	3.	Perform a test inflation of the system depressing the plunger rod with 2 hands, keeping the plunger rod straight. Ensure that the distal orange piston black O-ring seal is aligned with the distal black mark of the
Inflation Device during the test inflation (See Figure 5). Also ensure there is no air introduced into the system during the deflation of the balloon. If a leak is detected and the source cannot be identified and corrected, discard the XprESS
device, infusion line, and inflation device. Use new devices to complete the procedure. 

  

	4.	Pull back on the plunger rod to the stop (2nd Detent) position to apply a vacuum to the balloon. 

Patient Preparation. 
  

	1.	Patient preparation should be consistent with standard practice. 

  

	2.	Anesthesia should be administered appropriately to allow patient tolerance. 

 Locate the Sinus Structure 

 

	1.	Direct Visualization: Locate the treatment area or sinus structure using the standard sinus ostium seeker, suction tube (standard or XprESS) and/or guidewire with the aid of an endoscope. Observe the location of the
treatment area relative to the anatomical landmarks through the endoscope. Remove the sinus ostium seeker, suction tube or guidewire after locating treatment area. When treating the maxillary sinus ostia, removal of a portion of the uncinate process
may be required to achieve direct visualization. 

  

					
	1662-001-rG Oct 2010	 	XprESS Multi-Sinus Dilation Tool	 	Page 5 of 9

	2.	CT Image Guidance: If further confirmation of the treatment area location is desired, CT Image guidance using standard image guidance tools may be used. If CT image guidance is used, the CT scan data should be uploaded
into the image guidance system prior to the start of the procedure. Use only the tools recommended by the CT image system manufacturer. Do not attach the CT Image Guidance system to the XprESS device. 

XprESS Multi-Sinus Dilation Tool Operation 
  

	1.	Position device suction tip within the sinus structure. 

  

	 	a.	Under endoscopic visualization, track the XprESS device to the same treatment area identified in the section “Locate the Sinus Structure”. 

Note: Reference marks are located 1 and 2 cm from the tip of the device. 
  

	 	b.	Fluoroscopy: If further verification of the device placement prior to dilation is desired, fluoroscopy may be used. Take two orthogonal views (AP and lateral) of the sinus. The XprESS device suction tip is made up of
stainless steel and is visible under fluoroscopy. The balloon will be proximal to the tip of the device. 

  

	 	c.	To further enhance visualization under fluoroscopy, insert the flexible end of the selected 0.035” guidewire through the suction lumen (see Supplies Section for compatible guidewire). Feed the guidewire through the
lumen (device is approximately 27 cm in length) until the flexible tip exits the XprESS device. If resistance in the guidewire is met, reposition the XprESS device so that the guidewire can pass freely out the distal end of the lumen. If suction was
used through the suction lumen prior to guidewire advancement, clean the suction lumen by irrigating with sterile saline. 

 Note: The
XprESS device suction tip may be re-shaped to aid in device positioning. 
 Note: Use device as a suction tool to maintain a clear visual field during
device positioning. 
  

	2.	Advancing the balloon to the treatment site. 

 Under endoscopic visualization, fully advance the balloon slide
mechanism forward to position the balloon within the sinus opening. 
  

	3.	Prior to inflating balloon, discontinue the use of suction to decrease the risk of sinus barotrauma. 

  

	4.	Inflate balloon. 

  

	 	a	Slowly depress the plunger rod with 2 hands, keeping the plunger rod straight, to inflate the balloon. The pressure should be increased slowly (5–7 seconds) until the orange piston bottoms out (distal black seal
(o-ring) of the piston reaches the distal black mark on the inflation device – see Fig. 5). If these do not align, deflate the balloon and remove the XprESS device and perform a test inflation as described in step 3 of the System Preparation
section. Alignment of the mark with the 0-ring will ensure that 12 atm of pressure is reached. 

  
 

 
 Note: Do not use air or any gaseous medium to inflate the balloon. 

  

					
	1662-001-rG Oct 2010	 	XprESS Multi-Sinus Dilation Tool	 	Page 6 of 9

	 	b.	Inflate the balloon until the desired result is achieved or until it reaches 12 atm. Inflate the balloon for up to 20 seconds (less than or equal to 20 second), observe that the balloon is inflated endoscopically.

 Note: Do not exceed 12 atm. 
  

	 	c.	Deflate the balloon and observe the results endoscopically. Perform additional inflationsfor similar duration if needed until desired result is achieved. Typically 1-2 inflations are performed per sinus.

  

	 	Note:	To avoid barometric trauma to sinus tissue, do not use device in suction mode while balloon is inflated. 

  

	 	d.	After balloon dilation is complete, deflate the balloon by gently pulling back on the plunger rod to the stop (2nd detent) position. If air is introduced into the
system during deflation, remove the XprESS device and perform a test inflation as described in step 3 of the System Preparation section. 

  

	 	e.	Under endoscopic visualization, retract the balloon slide mechanism to withdraw the deflated balloon from the sinus opening. Endoscopically observe balloon dilation result. 

 

	 	f.	When the sinus outflow tract has been adequately dilated, remove the XprESS device from the treated sinus. 

  

	 	Note:	Adequate dilation can be visually confirmed by observing the balloon during inflation. For a full 12 atm inflation, advance the plunger until the orange piston bottoms out (distal black seal (o-ring) of the piston
reaches the distal black mark on the inflation device – see Fig. 5 for Illustration). 

  

	5.	Clean up the ostium site by cutting or removing flaps of tissue, fragments of exposed bone, or any other bone and mucosa that may obstruct or otherwise prevent re-establishment of ventilation and drainage of the sinus.

  

	6.	Prepare balloon for dilation of additional sinuses (if desired). 

  

	 	a.	Gently advance the plunger rod into the syringe barrel to slightly expand the balloon to remove any wrinkles using minimal pressure. 

 

	 	b.	Clean the balloon prior to introduction into another sinus. This may be done by wiping the balloon with sterile wet gauze or dipping the balloon in sterile saline or sterile water. 

 

	 	c.	Perform a test inflation of the balloon to ensure system integrity if system or device failure is suspected. Ensure that the distal orange piston black O-ring seal is aligned with the distal black mark of the Inflation
Device during the test inflation (See Figure 5 above). Also ensure there is no air introduced into the system during the deflation of the balloon. If a leak is detected and the source cannot be identified and corrected, discard the XprESS device,
infusion line, and inflation device. Use new devices to complete the procedure. 

  

	 	d.	With the distal tip of the XprESS device down, gently pull back on the plunger rod to the stop (2nd detent) position to apply vacuum to the balloon.

  

	7.	Repeat the same procedure to treat additional sinuses if desired. 

 Note: The XprESS device suction tip may
be re-shaped as required to treat additional sinuses. 
  

	8.	After completing the entire procedure, dispose of XprESS device, infusion line, guidewire if used, Inflation Device, and all waste product according to appropriate environmental health safety guidelines.

 How Supplied 
 The contents of the XprESS
Multi-Sinus Dilation Tool are provided sterile and are intended for single-use only. 
 Do not re-sterilize and/or re-use, as it may result in compromised
device performance and risk improper sterilization and cross contamination. 

  

					
	1662-001-rG Oct 2010	 	XprESS Multi-Sinus Dilation Tool	 	Page 7 of 9

 Do not use breached or damaged packages, since the sterility and functionality of the device may be compromised.

 The items packaged with the Xpress Multi-Sinus Dilation Tool include the Inflation Device and the Infusion Line. 

Limited Warranty 
 Entellus Medical, Inc. warrants that
reasonable care has been used in the design and manufacture of the XprESS Multi-Sinus Dilation Tool. This limited warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether expressed or implied, written or oral,
by operation of law or otherwise including, but not limited to, any implied warranties of merchantability or fitness for a particular purpose, or warranties arising from a course of dealing or usage or trade. Handling, storage, cleaning and
sterilization of the XprESS Multi-Sinus Dilation Tool, as well as other factors relating to the patient, diagnosis, treatment, medical procedures, and other matters beyond Entellus Medical, Inc.’s control, directly affect the XprESS Multi-Sinus
Dilation Tool and the results obtained from its use. This limited warranty does not extend to any abuse or misuse of the XprESS Multi-Sinus Dilation Tool (including, without limitation, off-label use), accident to or neglect of the XprESS
Multi-Sinus Dilation Tool, failure to follow any instructions or specifications provided with the XprESS Multi-Sinus Dilation Tool (including, without limitation, any re-use, re-processing or re-sterilization of the XprESS Multi-Sinus Dilation Tool
not in accordance with such instructions or specifications), in each case whether caused or carried out by Customer or by any third party. 
 Entellus
Medical’s obligation under this limited warranty is limited, at Entellus Medical, Inc.’s option, to the repair or replacement of the XprESS Multi-Sinus Dilation Tool for a period of twelve (12) months from the date of purchase (the
“Warranty Period”) using commercially reasonable efforts within a reasonable period of time. Entellus Medical, Inc. shall not be liable for any incidental or consequential loss, damage or expense directly or indirectly arising from
use of the XprESS Multi-Sinus Dilation Tool. Repair or replacement of the XprESS Multi-Sinus Dilation Tool shall not extend the term of any applicable warranty and the original term of such warranty shall remain in effect. Repairs, modifications or
alterations of the XprESS Multi-Sinus Dilation Tool performed by any person or entity other than Entellus Medical, Inc. or approved by Entellus Medical, Inc. in writing shall nullify and otherwise void all applicable warranties hereunder. 

Entellus Medical, Inc. shall be obligated to honor the express limited warranties contained herein only upon receipt of full payment for the XprESS
Multi-Sinus Dilation Tool or otherwise in accordance with the payment terms agreed to by Entellus Medical, Inc. and Customer. 
 Entellus Medical, Inc.
neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with the XprESS Multi-Sinus Dilation Tool. 

Limitation of Liability 
 In no event will either Entellus
Medical, Inc. or Customer be liable to the other or to any third party for loss of profit, goodwill or other indirect, incidental, special or consequential or other similar damages arising out of these Terms and Conditions or any Related Purchase
Document. The limitation of liability described in this section is in addition to any limitation provided for by the Limited Warranty provisions. 

  

					
	1662-001-rG Oct 2010	 	XprESS Multi-Sinus Dilation Tool	 	Page 8 of 9

 Symbols 
  

 
 ACCLARENT, RELIEVA, RELIEVA VIGOR, and RELIEVA LUMA are trademarks of Acclarent, Inc. 

US Patent Pending. 
 ©2010 Entellus Medical. All rights reserved. 
  
 

 

  

					
	1662-001-rG Oct 2010	 	XprESS Multi-Sinus Dilation Tool	 	Page 9 of 9

 Exhibit 8 

  
 

 
  
 

 
 Entellus Medical Functional INfundibular 

Endoscopic Sinus System. 

INSTRUCTIONS FOR USE 
 ALL
INSTRUCTIONS, PRECAUTIONS AND WARNINGS SHOULD BE CAREFULLY 
 READ AND UNDERSTOOD BEFORE USE. FAILURE TO DO SO MAY RESULT IN 

COMPLICATIONS. 
 Caution – Federal (USA) law
restricts this device to sale by or on the order of a physician. 

 System Description 

The Entellus Medical, Inc. Functional INfundibular Endoscopic Sinus System (FinESSTM) includes the following components:

 Micro-Trocar & Access Sheath 
 The
Micro-Trocar provides a small access hole into the Maxillary Sinus through the Canine Fossa. The Micro-Trocar also delivers the Access Sheath, which is intended to maintain consistent access for procedural devices (Cannula / Endoscope &
Balloon Catheter). 
  
 

 
 Figure 1 – Sinus Access Tools: Micro-Trocar Inserted Through Access Sheath 

Cannula 
 The Cannula is a dual lumen instrument that
allows both delivery of the Balloon Catheter and visualization with an Endoscope. The Cannula is sized to pass through the Access Sheath. 
  

 
 Figure 2 – Sinus Cannula 

Balloon Catheter 
 The Balloon Catheter is designed to
dilate the maxillary sinus ostium and the ethmoid infundibulum space. The balloon catheter includes a braided shaft design that allows for rotational positioning to accurately deliver the balloon into the ostium while navigating within the parasinus
space. 
  
 

 
 Figure 4 – Imaging Sleeve 

Inflation Device 
 The disposable Entellus Medical, Inc.
Inflation Device consists of a 25 cc syringe barrel with a pressure gauge, a threaded plunger assembly with a Winged Lock Mechanism used to generate and control balloon inflation pressures, and a flexible high pressure extension tube. The gauge is
calibrated from 0 to 30 atm (0 to 441 psi) of positive pressure. The accuracy of the gauge is within 1 atm over the range. Accuracy of syringe graduations: +5%. 

  

					
	1108-001-rG Oct 2010	 	FINESS Sinus Treatment	 	Page 2 of 10

 All components of the FinESSTM Sinus Treatment are provided sterile. 

Indication for Use 
 To access and treat the maxillary sinus
ostium and the ethmoid infundibulum in adults with a trans-antral approach. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinus structures. 

Contraindications 
 Patients with thickened polypoid mucosa
excessive enough to inhibit the visualization of the maxillary ostium should not be considered candidates for the FinESS Sinus Treatment. 
 Warnings 

 

	 	•	 	Only physicians possessing sufficient skill and expertise in similar technique (accessing maxillary sinus ostium and ethmoid infundibulum through canine fossa) should perform this procedure. 

 

	 	•	 	Do not use the FinESSTM Sinus Treatment if CT image indicates challenging anatomy such as a hypoplastic antrum or polypoid mucosa that may limit success of Canine Fossa approach. 

 

	 	•	 	Do not use opened or damaged packages. 

  

	 	•	 	The FinESS Sinus Treatment is intended for single procedure use only. Do not attempt to reuse or re-sterilize. Device integrity may be compromised. 

 

	 	•	 	Do not apply excessive penetration force when drilling the canine fossa access hole. Patient injury or device damage may occur. 

  

	 	•	 	Do not exceed the maximum recommended balloon inflation pressure (12 atm). Use of a pressure monitoring Inflation Device is required to prevent over-pressurization. 

 

	 	•	 	Do not advance or withdraw the Balloon when inflated. Mucosa damage or device damage may occur. 

  

	 	•	 	Inflation pressures should be closely monitored when inflating the balloon. The inflation device is a high volume, low compliance system capable of generating high pressure with relative ease. 

 

	 	•	 	As in any upper airway procedure or sinus surgery, do not use CPAP for approximately 7 days post-procedure with FinESSTM Sinus Treatment. CPAP usage prior to soft tissue healing may result in facial and/or neck
swelling due to subcutaneous emphysema. 

 Precautions 
  

	 	•	 	FinESS Sinus Treatment components should be stored in a cool and dry place. Never use a device that is beyond its expiration date. 

  

	 	•	 	FinESS Sinus Treatment components should be handled with care. Prior to use, and during the procedure, inspect the packaging and components for bends, kinks, or other damage. Discontinue the use of any component that
may have been damaged. 

  

	 	•	 	Pay special attention when advancing or withdrawing the Cannula or Balloon Catheter. Never advance, withdraw or torque any component that meets resistance, as this could cause kinking or breaking. If resistance is
encountered, use endoscopy to help guide device manipulation. If the cause of resistance cannot be determined, withdraw all components as a system. 

  

	 	•	 	The Balloon Catheter should only be manipulated under endoscopic observation. 

  

	 	•	 	The Balloon Catheter should be positioned with its curved tip in an inferior orientation when tracking through the maxillary sinus ostium and ethmoid infundibulum to avoid tracking into the agger nasi cell.

  

	 	•	 	Patients should be advised to sneeze with an open mouth and avoid extreme inhalation and blowing through the nose for approximately 7 days post-procedure to reduce the likelihood of inflammation and/or swelling due to
subcutaneous emphysema. 

  

					
	1108-001-rG Oct 2010	 	FINESS Sinus Treatment	 	Page 3 of 10

	 	•	 	It is important to review the patient’s CT image prior to performing the FinESS procedure in order to determine the most appropriate access location. 

Adverse Effects 
 Possible adverse effects include, but are not
limited to, the following: 
  

	 	•	 	Post-operative facial pain 

  

	 	•	 	Excessive bleeding in the nose and at the canine fossa 

  

	 	•	 	Complication from anesthesia 

  

	 	•	 	Fracture of the anterior wall of the maxillary sinus 

  

	 	•	 	Cerebrospinal fluid leak 

  

	 	•	 	Loss of vision or diplopia (double vision) 

  

	 	•	 	Damage to a tooth root or gingiva 

  

	 	•	 	Damage to nerves potentially causing temporary (and occasionally prolonged) numbness to the cheek, lip, or teeth; mid-facial pain; and tooth pain or hypersensitivity 

 

	 	•	 	Facial bruising and swelling 

  

	 	•	 	Swelling of the nose and cheek 

  

	 	•	 	Fever and infection 

  

	 	•	 	Tissue inflammation 

  

	 	•	 	Continued or worsening sinus symptoms 

 Supplies 

The following supplies need to be available and prepped prior to use of the FinESSTM Sinus Treatment. 

Note: These supplies are not provided with the FinESS Sinus Treatment. 
  

	 	•	 	Entellus Flexible Endoscope ES-100 (or Storz 0.5 mm Endoscope) and compatible camera system 

  

	 	•	 	Sterile Saline Solution 

  

	 	•	 	60 cc Syringe (if irrigation is to be performed) 

  

	 	•	 	Needles and Syringes as required for local anesthesia injections 

  

	 	•	 	Suction system 

  

	 	•	 	#5 and #7 Suction Tips 

  

	 	•	 	Other supplies or medication as per established laboratory protocol 

  

					
	1108-001-rG Oct 2010	 	FINESS Sinus Treatment	 	Page 4 of 10

 System Preparation 
  

	1.	Prepare Endoscope. 

  

	 	a.	Verify endoscope has been disinfected per appropriate instructions. 

 Note: The 0.5 mm
Endoscope should be handled with care. Avoid stretching or kinking the Endoscope. Device damage may occur. 
  

	2.	Prepare Cannula. 

  

	 	a.	Insert the Endoscope into the Cannula until it is flush with the Cannula tip. 

  

	 	b.	Tighten the scope retention valve (see Figure 2) to secure the scope within the Cannula. Verify the Endoscope is flush or just outside (approximately 0.5 mm) of the Cannula. 

 

	 	c.	Connect Endoscope to Camera System. 

  

	 	d.	While holding the Cannula with the Endoscope Retention Valve positioned down (see Figure 2), rotate the Camera relative to the eyepiece to align the image as desired. 

 

	3.	Prepare Micro-Trocar. 

  

	 	a.	Remove the Micro-Trocar and Access Sheath from their sterile package. 

  

	 	b.	Slide the Access Sheath onto the Micro-Trocar. Rotate Access Sheath on Micro-Trocar until Micro-Trocar Pin engages with Access Sheath allowing Access Sheath to lay flush against the Micro-Trocar (see Figure 1 ).

  

	4.	Prepare Inflation Device. 

  

	 	a.	Remove the Inflation Device from its sterile package. 

  

	 	b.	Turn the green lock mechanism counter clockwise to the unlocked position. 

  

	 	c.	Insert the extension tube into Sterile Saline Solution and pull back on the plunger handle to aspirate 15 – 20 cc. 

  

	 	d.	While holding the Inflation Device with the plunger handle down (so air accumulates by extension tube), advance the syringe plunger into the syringe barrel to purge air. Retain 8 – 10 cc of fluid in syringe barrel.

 Caution: Inspect the syringe tubing to ensure there is minimal air in the system. 

 

	5.	Prepare Balloon Catheter. 

  

	 	a.	Remove the Balloon Catheter from its sterile package. 

  

	 	b.	Connect the Inflation Device to the Balloon Catheter. 

  

	 	c.	While holding the Inflation Device with the plunger handle up, pull back on the plunger handle to apply a vacuum to the balloon. After air has been withdrawn from balloon into the syringe barrel, gently release the
plunger handle to release vacuum. 

  

	 	d.	Lock Inflation Device by turning green lock mechanism clockwise to locked position. 

  

	 	e.	Remove the Protective Sleeve from the Balloon. Retain the Sleeve for balloon re-wrapping. 

  

					
	1108-001-rG Oct 2010	 	FINESS Sinus Treatment	 	Page 5 of 10

 System Operation 
  

	1.	Patient preparation. 

  

	 	a.	Patient preparation should be consistent with standard practice. 

  

	 	b.	Anesthesia should be administered appropriately to allow patient tolerance. 

  

	2.	Access Maxillary Sinus 

  

	 	a.	Firmly lift and retract lip to visualize gingival tissue and feel for canine fossa recess. 

  

	 	b.	While retracting lip to minimize gingival tissue thickness, enter tissue with Micro-Trocar. 

  

	 	c.	After accessing gingival tissue, position Micro-Trocar tip on bony surface at the intersection location described in Figure 6. 

  

	 	Note:	The target access location is typically on the lateral side of the canine fossa recess. 

  

	 	Note:	Access location may be confirmed by gently angling the Micro-Trocar to be perpendicular to the facial plane while holding the Micro-Trocar tip on the bone at the target access location. 

 

	 	d.	While holding Micro-Trocar at appropriate angle (approximately 45 degrees from the facial plane with the Micro-Trocar tip pointed at the inside corner of the eye}, apply a back-and-forth rotational motion (versus a
pushing motion) to gently create an access hole. 

  

	 	Note:	Do not apply excessive penetration force when making access hole. 

  

 
 Figure 5 –Target Access Site Location 

 

	 	e.	After sinus access is achieved, continue rotating Micro-Trocar with back-and-forth motion while gently angling the Micro-Trocar tip toward the Maxillary Sinus Ostium (corner of the eye). The gentle side-cutting motion
provides a range of motion for the Cannula to visualize the Sinus Ostium. 

  

	 	Note:	The Micro-Trocar must be rotated with a back-and-forth motion prior to angling the Micro-Trocar. 

  

	 	Note:	The Micro-Trocar Pin must be engaged with the Access Sheath to allow side-cutting. If Pin pulls out of Access Sheath, re-insert and continue Micro-Trocar rotations. 

  

					
	1108-001-rG Oct 2010	 	FINESS Sinus Treatment	 	Page 6 of 10

	 	f.	While holding Access Sheath in access site, slide the Micro-Trocar out of the Access Sheath. 

  

	 	Note:	If Access Sheath slips out of access site (even if it Is just removed from the hole in the bone) at any time, re-load Access Sheath onto Micro-Trocar and use Micro-Trocar to locate original hole, or to
re-access in a secondary location. Do not attempt to re-access the hole with the Access Sheath only. Access Sheath damage may occur. 

  

	 	g.	Use a standard #5 suction tip to aspirate fluid from the access sheath as required. 

  

	3.	Insert Cannula into Access Sheath under endoscopic visualization. 

  

	 	Note:	The Cannula should be inserted up to the Cannula Shaft Mark (see Figure 2) to ensure the Cannula passes completely through the Access Sheath. Failure to accurately position the Cannula Shaft Mark may result in
balloon damage. 

  

	 	Note	At any time during the procedure, the Cannula may be removed from the Access Sheath to clean the Endoscope by gently pulling the Cannula tip I Endoscope tip across a surgical wipe
soaked in an appropriate cleaning medium. 

  

	4.	Visualize presence of air / fluid level within sinus. 

  

	 	a.	If fluid level impedes endoscopic visualization, aspiration and/or irrigation may be required. 

  

	 	b.	Remove Cannula from Access Sheath to complete aspiration and/or irrigation. 

  

	 	c.	Insert Cannula into Access Sheath. Verify acceptable fluid level. Excess residual saline in the sinus should be gently aspirated through a standard #5 suction device. 

 

	5.	Visualize the maxillary sinus ostium. 

  

	 	a.	While holding the Access Sheath in the access site, gently manipulate the Cannula to visualize the maxillary sinus ostium. 

  

	 	b.	While visualizing the ostium, topical anesthetic may be sprayed through the Cannula for additional topical anesthesia as required. 

  

	 	Note:	Use suction to remove residual anesthetic from Cannula using a standard #5 tip as required. 

  

	6.	Introduce the Balloon Catheter through the Cannula. 

  

	7.	Advance the Balloon across the ostium under endoscopic visualization. 

  

	 	a.	When the Balloon Catheter tip is positioned just outside of the ostium, advance the balloon into the sinus ostium with the curved catheter tip pointed posterior / inferior. 

 

	 	Note:	The arrow on the Balloon Catheter hub indicates the direction of the tip curve. 

  

	 	b.	Using the Shaft Marker (see Figure 3) as a visual reference for the proximal balloon end, position the Balloon within the ostium / infundibulum. 

Note: The Balloon Catheter may be rotationally steered to allow full insertion of the balloon into the ostium and infundibulum. 

 

	8.	Inflate Balloon. 

  

	 	a.	Slowly turn the plunger handle clockwise to increase the pressure. Inflate balloon in 2 atm increments under endoscopic visualization. 

 

	 	Note:	Do not use air or any gaseous medium to inflate the balloon. 

  

	 	b.	Inflate sinus balloon until desired result is achieved. 

  

	 	Note:	Do not exceed the maximum pressure of 12 atm. 

  

	 	c.	After balloon dilation is complete, deflate the sinus balloon by turning the Inflation Device green lock mechanism to unlocked position and pulling back on the plunger handle to apply vacuum to the balloon

  

					
	1108-001-rG Oct 2010	 	FINESS Sinus Treatment	 	Page 7 of 10

	 	d.	Lock Inflation Device by turning the green lock mechanism to locked position to maintain balloon vacuum. 

  

	 	e.	Verify the Cannula is inserted into the Access Sheath up to the Shaft Mark to ensure the Cannula tip is inserted beyond the Access Sheath. 

 

	 	f.	Withdraw balloon from Cannula under endoscopic visualization. 

  

	 	Note:	Rotating the Catheter as the Balloon begins to engage the Cannula will assist in balloon withdrawal. 

  

	9.	Endoscopically observe balloon dilation result. 

  

	 	a.	If the maxillary sinus ostium has been adequately dilated, remove Cannula and Access Sheath from access site. 

  

	 	Note:	Adequate dilation can be visually confirmed by observing the balloon during inflation, visually verifying balloon positioning during inflation, and ensuring that the recommended inflation pressure is achieved.

  

	 	b.	If additional balloon dilation is required, prepare Balloon Catheter per step 10 and repeat steps for Balloon inflation. 

  

	10.	Prepare Balloon Catheter for additional dilations (if required). 

  

	 	a.	Turn the Inflation Device green lock mechanism to unlocked position to release balloon vacuum. 

  

	 	b.	Gently advance the plunger handle into the syringe barrel to expand the balloon using minimal pressure. 

  

	 	c.	Rinse balloon with sterile saline or water. 

  

	 	d.	Wipe balloon dry using gauze pad. 

  

	 	e.	Position three fingers equally spaced on the balloon to serve as tri-fold guides. Ensure Inflation Device is unlocked then gently squeeze the balloon to force fluid into syringe barrel and tri-fold balloon.

  

	 	f.	Gently pull back on the plunger handle about 2 – 4 cc to apply vacuum to the balloon. After fluid has been withdrawn from balloon, turn the Inflation Device green lock mechanism to locked position.

  

	 	g.	Re-wrap the tri-folded balloon by gently folding the wings around the catheter shaft in a clockwise direction. 

  

	 	h.	Slide the Protective Sleeve on the re-wrapped balloon to restore original balloon profile. 

  

	 	i.	Before additional balloon dilatation, remove the Protective Sleeve from the Balloon. Retain the Sleeve for Balloon re-wrapping. 

  

	11.	Repeat procedure for contralateral maxillary sinus if needed. 

  

	 	Note:	The scope image may need to be re-aligned prior to viewing second side. While holding the Cannula with the Endoscope Retention Valve positioned down (see Figure 2), rotate the Camera relative to
the eye piece to align the image as desired. 

  

	12.	After completing the entire procedure, withdraw all system components and discard. 

  

					
	1108-001-rG Oct 2010	 	FINESS Sinus Treatment	 	Page 8 of 10

 Limited Warranty 

Entellus Medical, Inc. warrants that reasonable care has been used in the design and manufacture of the FinESS Sinus Treatment system. This limited warranty is
in lieu of and excludes all other warranties not expressly set forth herein, whether expressed or implied, written or oral, by operation of law or otherwise including, but not limited to, any implied warranties of merchantability or fitness for a
particular purpose, or warranties arising from a course of dealing or usage or trade. Handling, storage, cleaning and sterilization of the FinESS Sinus Treatment system, as well as other factors relating to the patient, diagnosis, treatment, medical
procedures, and other matters beyond Entellus Medical, Inc.’s control, directly affect the FinESS Sinus Treatment system and the results obtained from its use. This limited warranty does not extend to any abuse or misuse of the FinESS Sinus
Treatment system (including, without limitation, off-label use), accident to or neglect of the FinESS Sinus Treatment system, failure to follow any instructions or specifications provided with the FinESS Sinus Treatment system (including, without
limitation, any re-use, re-processing or re-sterilization of the FinESS Sinus Treatment system not in accordance with such instructions or specifications), in each case whether caused or carried out by Customer or by any third party. 

Entellus Medical’s obligation under this limited warranty is limited, at Entellus Medical, Inc.’s option, to the repair or replacement of the FinESS
Sinus Treatment system for a period of twelve (12) months from the date of purchase (the “Warranty Period”) using commercially reasonable efforts within a reasonable period of time. Entellus Medical, Inc. shall not be liable
for any incidental or consequential loss, damage or expense directly or indirectly arising from use of the FinESS Sinus Treatment system. Repair or replacement of the FinESS Sinus Treatment system shall not extend the term of any applicable warranty
and the original term of such warranty shall remain in effect. Repairs, modifications or alterations of the FinESS Sinus Treatment system performed by any person or entity other than Entellus Medical, Inc. or approved by Entellus Medical, Inc. in
writing shall nullify and otherwise void all applicable warranties hereunder. 
 Entellus Medical, Inc. shall be obligated to honor the express limited
warranties contained herein only upon receipt of full payment for the FinESS Sinus Treatment system or otherwise in accordance with the payment terms agreed to by Entellus Medical, Inc. and Customer. 

Entellus Medical, Inc. neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection
with the FinESS Sinus Treatment system. 
 Limitation of Liability 

In no event will either Entellus Medical, Inc. or Customer be liable to the other or to any third party for loss of profit, goodwill or other indirect,
incidental, special or consequential or other similar damages arising out of these Terms and Conditions or any Related Purchase Document. The limitation of liability described in this section is in addition to any limitation provided for by the
Limited Warranty provisions. 

  

					
	1108-001-rG Oct 2010	 	FINESS Sinus Treatment	 	Page 9 of 10

 Symbols 
  

 
 This product is protected by US Patent No. 7,520,876. Other US Patents Pending. 

©2009 Entellus Medical. All rights reserved. FinESS is a trademark of Entellus
Medical. 
  
 

 

  

					
	1108-001-rG Oct 2010	 	FINESS Sinus Treatment	 	Page 10 of 10

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