##### 



MICRUS ENDOVASCULAR CORPORATION
 and
 BIOTRONIK AG
 
 LICENSE, DEVELOPMENT
 and
 DISTRIBUTION AGREEMENT
 As of January 6, 2006
 
 Certain confidential information contained in this document, marked by brackets, has been omitted
and filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934, as amended.




---



##### 



TABLE OF CONTENTS
 Page1.
    
    DEFINITIONS
    
    12.
    
    DEVELOPMENT; STEERING COMMITTEE
    
    63.
    
    LICENSE GRANTS
    
    94.
    
    RESEARCH PAYMENTS AND COSTS
    
    105.
    
    LICENSE FEES; ROYALTY PAYMENTS
    
    116.
    
    ROYALTY REPORTS, PAYMENTS AND ACCOUNTING
    
    127.
    
    MANUFACTURING; SUPPLY AND DISTRIBUTION
    
    138.
    
    FORECASTS, PURCHASE ORDERS, ORDER ACCEPTANCE
    
    159.
    
    DELIVERY, LATE DELIVERY, SHIPMENT DESTINATION, ACCEPTANCE
    
    1610.
    
    PRICES, PAYMENT TERMS
    
    1711.
    
    PRODUCT CHANGES
    
    1712.
    
    WARRANTIES, REPRESENTATIONS AND COVENANTS
    
    1813.
    
    INDEMNIFICATION
    
    1914.
    
    TERM AND TERMINATION
    
    2115.
    
    ASSURANCE OF SUPPLY
    
    2116.
    
    REGULATORY AFFAIRS
    
    2217.
    
    QUALITY MANAGEMENT
    
    2318.
    
    LIMITED WARRANTY
    
    2319.
    
    REPORTING, PRODUCT ANALYSIS, VIGILANCE, REMEDIAL ACTION
    
    2520.
    
    LICENSED PATENTS
    
    2621.
    
    CONFIDENTIALITY; PUBLICATIONS
    
    2722.
    
    MISCELLANEOUS
    
    27




---



##### 



LICENSE, DEVELOPMENT
AND
DISTRIBUTION AGREEMENT
 Agreement Effective
Date Biotronik
 RECITALS
       DEFINITIONS.
 Agreement
 Affiliate
 1




---



##### 



AMS
 Calendar Quarter
 Claim
 Confidential Information
      Contract Year
 2




---



##### 



Deliverables
 Developed Product
 Development Steering Committee
 FTE
 Fully Burdened Manufacturing Cost
 GAAP U.S. generally accepted accounting principles
 Know-How
 3




---



##### 



Licensed Patents
 Licensed Technology
 Minimum Purchase Orders
 Net Sales
 Party
 Product
  Certain confidential information contained in this document, marked by brackets, has been omitted
and filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934, as amended.
 4




---



##### 



Proprietary Rights
    Product Specifications
 Statement of Work
 Technical Information
 Term
 Third Party
 Valid Claim
 Warranty Period
 5




---



##### 



Interpretive Rules. Articles Sections Schedules Exhibits including including but not limited to herein hereof hereunder
 DEVELOPMENT; STEERING COMMITTEE.
 Collaboration.
 Scope of Project. Exhibit C
 Development Schedule.
 Development Responsibilities.
 Diligence in Development.
  Certain confidential information contained in this document, marked by brackets, has been omitted
and filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934, as amended.
 6




---



##### 



Establishment and General Responsibilities of the Development Steering Committee.
 Meetings.
 Professional Standards.
 7




---



##### 



Change Process.
   Expenses.
 Monthly Reports.
 Site Visits.
 Delivery and Acceptance.
 8




---



##### 



LICENSE GRANTS.
 Grant of License.
  Exclusivity.
 Clawback.
 9




---



##### 



Biotronik Exclusive Rights.
 RESEARCH PAYMENTS AND COSTS.
 Development Research Funding. 
 Reports.
 Procedures.
 Cost of Audits.
  Certain confidential information contained in this document, marked by brackets, has been omitted
and filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934, as amended.
 10




---



##### 



Period to be Kept.
 LICENSE FEES; ROYALTY PAYMENTS.
 License Fees.
 
 
 
 
 
 5.2 Royalties.
  Certain confidential information contained in this document, marked by brackets, has been omitted
and filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934, as amended.
 11




---



##### 



5.3 Terms of Payment.
 5.4 Taxation of Royalties.
 5.5 Royalty Reduction for Third Party Patents.
 5.6 Royalty Term; Single Royalty.
 5.7 Currency Transfer Restrictions.
 ROYALTY REPORTS, PAYMENTS AND ACCOUNTING.
 Reports.
 Procedures.
 12




---



##### 



Cost of Audits.
 Period to be Kept.
 Marketing.
 MANUFACTURING; SUPPLY AND DISTRIBUTION.
 Exclusive Distribution Rights.
 Packaging and Labeling.
 Alteration of Products, Expired Products.
  13




---



##### 



Marketing Efforts.
    Trademarks.
 Customer Service.
 Sales and Technical Literature.
   14




---



##### 



FORECASTS, PURCHASE ORDERS, ORDER ACCEPTANCE.
 Forecasts.
   Purchase Order.
   Order Acceptance.
 Lead Time.
 15




---



##### 



Purchase before Approval.
 Minimum Purchase Orders.
 DELIVERY, LATE DELIVERY, SHIPMENT DESTINATION, ACCEPTANCE
 Delivery.
 Late Delivery.
 Acceptance of the Products.
 16




---



##### 



Packaging and Labelling.
 PRICES, PAYMENT TERMS.
 Prices.
 Payment Terms.
 Late Payment Interest.
 PRODUCT CHANGES.
 Change of Products.
 Notification of Change.
   Certain confidential information contained in this document, marked by brackets, has been omitted and filed
with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 17




---



##### 



Required Changes caused by Remedial, Preventive or Corrective Measure.
 WARRANTIES, REPRESENTATIONS AND COVENANTS.
         18




---



##### 



Disclaimer.
 INDEMNIFICATION.
 Indemnification by Micrus.
 Indemnification by Biotronik.
 19




---



##### 



LIMITED LIABILITY.
 Insurance.
 20




---



##### 



TERM AND TERMINATION.
 Term.
 Termination for Cause.
 Termination Without Cause.
 Accrued Rights and Obligations.
 ASSURANCE OF SUPPLY.
  21




---



##### 



REGULATORY AFFAIRS.
 Regulatory Approval.
 Additional Approvals.
 Regulatory Support.
 Sale or Import without Regulatory Approval.
 22




---



##### 



Cooperation.
 QUALITY MANAGEMENT.
 Quality Management System.
   Compliance Inspection.
 Traceability by Biotronik.
 Traceability by Micrus.
 LIMITED WARRANTY.
 Warranty Period.
 23




---



##### 



Warranty Conditions.
     Notification, Replacement or Credit.
     24




---



##### 



REPORTING, PRODUCT ANALYSIS, VIGILANCE, REMEDIAL ACTION.
 Complaints.
 Safety Notification.
 Micrus Endovascular Corporation
    
    Biotronik AGAttn. Medical Device Safety Officer
    
    Attn. Medical Device Safety OfficerStreet 821 Fox Lane
    
    Ackerstrasse 6San Jose, California 95131
    
    CH-8180 Bülach, SwitzerlandTel.: +1 408 433 1400
    
    Tel.: + 41 44 864 1069Fax: +1 408 433 1401
    
    Fax: + 41 1 864 50 05
 Product Analysis.
 No Statement.
 Sales Records.
 25




---



##### 



Product Recall.
 Remedial Actions.
 LICENSED PATENTS.
 Prosecution.
 Enforcement.
 26




---



##### 



CONFIDENTIALITY; PUBLICATIONS.
 Confidentiality.
 Public Announcements.
 Safety.
 MISCELLANEOUS.
 Employee Solicitation.
   Compliance with Laws.
 27




---



##### 



Entire Agreement.
 Amendment or Modification.
 28




---



##### 



Severability.
 Assignment.
 Notices
  If to Biotronik:
    
    Biotronik AG
Ackerstrasse 6
CH-8180 Bülach
Attn: CEOIf to Micrus:
    
    Micrus Endovascular Corporation
610 Palomar Avenue
Sunnyvale, CA 94085
Attention: CFO
  Force Majeure.
 29




---



##### 



Governing Law.
 Dispute Resolution.
 Binding Effect.
 Waiver.
 Schedules.
 Headings.
 Counterparts.
 30




---



##### 



MICRUS ENDOVASCULAR CORPORATION
    
    
    
    BIOTRONIK AGBy:
    
    /s/ Robert A. Stern
    
    
    
    By:
    
    /s/ MartiniName:
    
    Robert A. Stern
    
    
    
    Name:
    
    MartiniTitle:
    
    Executive Vice President
    
    
    
    Title:
    
    CEO
 31




---



##### 



EXHIBIT A
 Biotronik Product List as per November 2nd 2005
 a) Agreed upon Products:[***]
   Certain confidential information contained in this document, marked by brackets, has been omitted and filed
with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




---



##### 



EXHIBIT B
 Biotronik Patent Group
 Category
    
    
    Description
    
    
    Application/Publication No
    
    
    Patent No[***]
    
    
    
    [***]
    
    
    
    
    [***]
    
    
    
    
    [***]
   Certain confidential information contained in this document, marked by brackets, has been omitted and filed
with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




---



##### 



EXHIBIT C
 INITIAL
STATEMENT OF WORK




---



##### 



Statement of Work Micrus  Biotronik Neurovascular
 
 Project name:
    
    Lekton Motion Neuro (Pharos)Project No.:
    
    P0249
    
    Status /Rev: 06-Jan-06/1Type of ProjectXNew product
    
    o Marketing studyo Research
    
    XRegistrationo Prototype
    
    o Other:
 1 Project Scope:
   2. Excluded project scope:
  3. Comments:
    4. Time schedule
 Milestones
    
    Date
    

RemarksApplication for Specification
    
    
    24.01.05
    
    
    Biotronik Vision TeamApplication for Planning/Execution
    
    
    20.09.05Review Design Input
    
    
    11.11.05Review Design Output
    
    
    13.12.05
    
    
    Together with review validationReview Validation
    
    
    13.12.05
    
    
    Mechanical Validation only / clinical
assessment to be completed after physicians
inputEstimated Regulatory Approval (LM
amber)
    
    
    28.02.06
    
    
    Best case, depending on LGA review and availability of clinical dataProduct Release (LM amber)
    
    
    15.03.06Estimated Regulatory Approval (LM blue)
    
    
    30.03.06
    
    
    Assessment depending on LGAProduct Release (LM blue)
    
    
    30.04.06
    
    
    With minimum 2 y shelf life (accelerated ageing)
  SOW FINAL
    
    1/3




---



##### 



5. Budget
 Budget (EUR):
    
    Specification
    
    
    Planning
    
    
    Execution
    
    
    Total per typeInternal labor costsContractor labor costsExternal RD costsNon labor costsCollaboration ManagementTotal per phase
 For the Lekton Motion (amber and blue) the total project costs are 120000 EURO.
  
 
 
  6. Transfer price
  Direct cost per product
    
     na for this projectIndirect cost (plus 40%)
    
     na for this projectTotal Transfer Price excluding VAT
    
    200
  7. Forecast
  th
 8. Deliverables
     SOW FINAL
    
    1/2




---



##### 



Issued by : Name
    
    Approved by Biotronik
    
    Approved by MicrusDate/Sign: 06.Jan.2006
    
    Date/Sign:
/s/ Claus Martini
    
    Date/Sign: /s/ Robert Stern
 Attachments
   SOW FINAL
    
    3/3




---



##### 



Project Name:
    
    LM NeuroProject No:
    
    P0249
    
    SAP Project No:
    
    PR140000080PFH No/Rev:
    
    PFH 112091 Rev.1
    
    Ref. LTH No/Rev:
    
    N.A.Effective Date:
    
    11.11.05File Name
    
    PFH_112091_Rev1_LM_Neuro.doc
 Contents:
 1
    
    Project scope
    
    
    21.1
    
    Project goals
    
    
    21.2
    
    Geographical markets
    
    
    21.3
    
    Launch date
    
    
    22
    
    Clinical indications/ Intended use
    
    
    23
    
    Product name
    
    
    24
    
    Competitor products
    
    
    24.1
    
    Reference products for benchmarking
    
    
    24.2
    
    Parent (Biotronik) products
    
    
    25
    
    Applicable standards and documents
    
    
    26
    
    Risk management
    
    
    36.1
    
    Related risk analysis
    
    
    36.2
    
    Related human factor analysis
    
    
    37
    
    Technical product requirements / characteristics
    
    
    37.1
    
    Technical requirements for the T4XS / T4S / T4L / T4XL stent
    
    
    37.2
    
    Technical specifications for the entire LM Neuro System
    
    
    57.3
    
    Sizes
    
    
    88
    
    Product range
    
    
    99
    
    Target manufacturing costs
    
    
    910
    
    Packaging / Labelling
    
    
    911
    
    Sterilisation
    
    
    912
    
    Shelf life
    
    
    913
    
    Product compatibility
    
    
    913.1
    
    Compatibility with accessories / auxiliary devices
    
    
    913.2
    
    Compatibility with contrast media
    
    
    914
    
    Approval
    
    
    1014.1
    
    Issued by:
    
    
    1014.2
    
    Approval Micrus
    Fehler! Textmarke nicht definiert.




---



##### 



1 Project scope
 1.1 Project goals
  
    
    Modify stent implantation procedure for neurovascular vessels: slow inflations, no overdilatation
 1.2 Geographical markets
 
    
    EU (CE-Mark)
    
    USA (HDE)
 1.3 Launch date
 
    
    EU March 06
    
    USA tbd
 2 Clinical indications / Intended use
   3 Product name
  4 Competitor products
 4.1 Reference products for benchmarking
  
    
    Neuroform (pattern product for aneurysm)
    
    Cerebrence, Medtronic (subject to product availability)
    
    Neurolink, Guidant (subject to product availability)
 4.2 Parent (Biotronik) products
 
    
    N.A., Lekton Motion
 5 Applicable standards and documents
  
    
    SOP 100741
    Design Control
    
    AGP 102610
    RD guideline to AC/DC list for development projects
    
    ISO EN 10993
    Biocompatibility




---



##### 



6 Risk management
 6.1 Related risk analysis
  
    
    PRA112030
 6.2 Related human factor analysis
  
    
    HUF112094
 7 Technical product requirements / characteristics
 7.1 Technical requirements for the T4XS / T4S / T4L / T4XL stent
 Criteria
    
    Specification1. Material:
    
    Stainless steel for surgical implants AISI 316L, as
defined by ISO 5832-1, ASTM F138-92.2. Design
    
    Sinusoidal design of the bearing meanders with
transverse joints, straight end of stent due to special
V-form. Wall thickness: 130 ±10mm for T4XLWall thickness: 90+10mm for T4S and LWall thickness: 80 ±10mm for T4XS3. Surface
    
    The stents metal body shall be electro-polished.4. Variants (stent diameter):
    
    The stent shall be available in four size variants:- A small T4 variant (designation XS) for dilatation
diameters of 2,0; 2,25 and 2,5 mm; and- A small T4 variant (designation S) for dilatation
diameters of 2,75 and 3,0 mm; and- A larger T4 variant (designation L) for dilatation
diameters of 3,5 and 4,0 mm; and- A larger T4 variant (designation XL) for dilatation
diameters of 4,5 and 5,0 mm.5. Variants (stent lengths):
    
    The stent shall be available in the following lengths:T4XS:8, 10, 13, 15, 18, 20 mmT4S: 8, 10, 13, 15, 18, 20, 22, 25, 30 mmT4L: 8, 10, 13, 15, 18, 20, 22, 25, 30 mmT4XL: 13, 20, 30, 40 mm6. Oversizing
    
    All diameter variants must withstand the following
diameter without strut fracture (T4XS up to 3,0mm max.,
T4S up to 3,5mm max., T4L up to 4,5mm max. and T4XL up
to 5,5mm max.)




---



##### 



Criteria
    
    Specification7. Pressure required for stent
dilatation:
    
    Up to a balloon pressure of
£ 1 bar no diameter change of 3 20%
of the crimped profile shall occur. At a balloon pressure of 3
4 bar the stent shall have an evenly expanded geometry.8. Elastic recoil:
    
    Recoil £ 5 % for reference sizes: T4XS: 2.5/15; T4S: 3.0/15; T4L
4.0/15; T4XL: 5.0/20.9. Flexural rigidity when expanded
    
    El of dilated stent £ 50 Nmm2 for reference T4XL 5,0/20El of dilated stent
£ 20 Nmm2 for reference sizes: T4S: 3.0/15; T4L: 4.0/15El of dilated stent £ 10 Nmm2 for reference T4XS 2,5/1510. Maximum radial force (collapse
pressure)
    
    Pcoll
3 0.9 bar for reference sizes: T4XS:
2.5/15;
Pcoll 3 0.9 bar
for reference sizes: T4S: 3.0/15; T4L: 4.0/15;
Pcoll 3 1.1 bar for reference sizes: T4XL: 5.0/20.11. Foreshortening of stent during
    
    DL < 5 % for reference sizes: T4XS: 2.5/15; T4S: 3.0/15; T4L:expansion:
    
    4.0/15; T4XL 5.0/20.12. Crack formation:
    
    Stent body surface testing: no cracks or ruptures in the metal stent
body up to and including maximum diameter.13. Opening behavior
    
    Stent diameter shall not display any difference > 10% over the
entire length at nominal balloon pressure. After complete expansion
the stent must still be positioned between the SDS markers.14. FEM analysis
    
    An FEM analysis shall be performed in order to determine the level
of stress at maximum physiological load. Crimping behavior and
subsequent dilatation to the maximum designated diameter shall be
simulated. As a result the equivalent stress levels and maximum
expansion shall be documented.15. Fatigue testing
    
    A dynamic fatigue resistance simulation is required to determine
long-term behavior under implantation conditions. The implantation
duration shall be at least 10 years with at least 420 Mio. stress
cycles at a temperature of 37°C.16. Surface coverage
    
    The percentage of the vessel wall covered by the dilated stent in
dependency on the stents expanded diameter shall be calculated.17. Radiopacity
    
    All stent variants with markers must be visible under X-rays in an
undilated and dilated condition. This shall be achieved by applying
a gold marker to each end by galvanization.18. Coating
    
    The stent s metal body and the gold markers shall be coated with
amorphous silicon carbide (a-SiC:H); requirements see DSP-621-014.19. MR safety
    
    Tests for MR safety (magnetic field interactions, heating and
artifacts) will be conducted using 3.0 Tesla MR system.20. Corrosion resistance
    
    The stent shall be resistant to corrosion when subjected to
physiological conditions at the implantation site.




---



##### 



7.2 Technical specifications for the entire LM Neuro System
  Criteria
 1
    
    Design (same as the Lekton Motion coronary stent)
 Specification
    2
    
    Catheter Characteristic (same as the Lekton Motion coronary stent)
 
    a.)
    
    Effective lengthb.)
    
    Crossing Profile = crimp diameter stentc.)
    
    Deflation time from NP (water / contrast medium mixture 50/50% or glycerin/water mixture
30/70%)
 Æ £
 Æ £
    d.)
    
    Inflation time to NP (water / contrast medium mixture 50/50% or glycerin/water mixture
30/70%)
 
    e.)
    
    TrackabilityReference sizes 3.0/15
 
    3
    
    Balloon Characteristic (same as the Lekton Motion coronary stent)
 
    a.)
    
    Materialb.)
    
    Balloon diameter [mm] at nominal pressure (NP)
 
    c.)
    
    Balloon length [mm]
 £
    d.)
    
    Nominal pressure (NP) Stent inner diameter
 £
    e.)
    
    Rated Burst Pressure (RBP) measured with the stent mounted on the balloon
 Æ 3
 Æ 3
    f.)
    
    Radial Compliance (NP to RBP) of the stent inner diameter
 
    g.)
    
    Axial Compliance (NP to RBP) measured with the stent mounted on the balloon
 
    4
    
    Stent
 
    a.)
    
    General technical requirementsb.)
    
    Crimp diameter [mm]
 £




---



##### 



£
 £
 £
 £
    
 3
 3
  3
 3
  3
 3
  3
 3
    
 
    
 
    5 Hub, kink protector, clip (same as the
Lekton Motion coronary stent)
 
    
 
    
 
    6 Proximal Shaft (same as the Lekton Motion coronary stent)
     
 
    
 
    7 Distal Shaft (same as the Lekton Motion coronary stent)




---



##### 



Dimension:
    
    Balloon 2.0  3.5: 2.6FBalloon 4.0: 2.7FBalloon 4.5  5.0: 2.9Fb.) Proximal Outer Tubing (POT)Material:
    
    PA 12, color: yellowDimension:
    
    3.1Fc.) Inner tubing (guide wire lumen)Material:
    
    Two layer tubing:- inner layer: PTFE (good gliding properties)- outer layer: PEBAX 72DDimension:
    
    Inner diameter > 0.43mm (-» compatibility with 0.014 GW)8 Tip (same as the Lekton Motion coronary stent)a.) Material:
    
    Soft and flexibleColor:
    
    Blueb.) Length
    
    12 mm9 Balloon marker (same as the LektonMotion coronary stent)a.) Material / Dimension
    
    Platinum/Iridium (90/10) / Length: 0.5mmb.) Marker concept
    
    Distal and proximal from the stent endsc.) Distance between markers
    
    £ stent length + 1.0mm10 Coating (same as the Lekton Motioncoronary stent)a.) Shaft proximal
    
    Hydrophobic Coatingb.) Shaft distal
    
    Hydrophilic Coating11 Printing (same as the Lekton Motioncoronary stent)a.) On hub
    
    Product name, nominal stent diameter /stent
length / Lot number  unit number




---



##### 



7.3 Sizes
 Pos.
    
    
    Bezeichnung
    
    Durchm.
    
    

Länge
    
    
    Pos.
    
    
    Bezeichnung
    
    
    Durchm.
    
    

LängeT4 XS-XR
    
    
    
    
    
    T4 S-XR1
    
    
    LM Neuro 2.0/8
    
    
    2.0
    
    
    
    8
    
    
    
    19
    
    
    LM Neuro 2.75/8
    
    
    2.75
    
    
    
    82
    
    
    LM Neuro 2.25/8
    
    
    2.25
    
    
    
    8
    
    
    
    20
    
    
    LM Neuro 3.0/8
    
    
    3.0
    
    
    
    83
    
    
    LM Neuro 2.5/8
    
    
    2.5
    
    
    
    8
    
    
    
    21
    
    
    LM Neuro 2.75/10
    
    
    2.75
    
    
    
    104
    
    
    LM Neuro 2.0/10
    
    
    2.0
    
    
    
    10
    
    
    
    22
    
    
    LM Neuro 3.0/10
    
    
    3.0
    
    
    
    105
    
    
    LM Neuro 2.25/10
    
    
    2.25
    
    
    
    10
    
    
    
    23
    
    
    LM Neuro 2.75/13
    
    
    2.75
    
    
    
    136
    
    
    LM Neuro 2.5/10
    
    
    2.5
    
    
    
    10
    
    
    
    24
    
    
    LM Neuro 3.0/13
    
    
    3.0
    
    
    
    137
    
    
    LM Neuro 2.0/13
    
    
    2.0
    
    
    
    13
    
    
    
    25
    
    
    LM Neuro 2.75/15
    
    
    2.75
    
    
    
    158
    
    
    LM Neuro 2.25/13
    
    
    2.25
    
    
    
    13
    
    
    
    26
    
    
    LM Neuro 3.0/15
    
    
    3.0
    
    
    
    159
    
    
    LM Neuro 2.5/13
    
    
    2.5
    
    
    
    13
    
    
    
    27
    
    
    LM Neuro 2.75/18
    
    
    2.75
    
    
    
    1810
    
    
    LM Neuro 2.0/15
    
    
    2.0
    
    
    
    15
    
    
    
    28
    
    
    LM Neuro 3.0/18
    
    
    3.0
    
    
    
    1811
    
    
    LM Neuro 2.25/15
    
    
    2.25
    
    
    
    15
    
    
    
    29
    
    
    LM Neuro 2.75/20
    
    
    2.75
    
    
    
    2012
    
    
    LM Neuro 2.5/15
    
    
    2.5
    
    
    
    15
    
    
    
    30
    
    
    LM Neuro 3.0/20
    
    
    3.0
    
    
    
    2013
    
    
    LM Neuro 2.0/18
    
    
    2.0
    
    
    
    18
    
    
    
    31
    
    
    LM Neuro 2.75/22
    
    
    2.75
    
    
    
    2214
    
    
    LM Neuro 2.25/18
    
    
    2.25
    
    
    
    18
    
    
    
    32
    
    
    LM Neuro 3.0/22
    
    
    3.0
    
    
    
    2215
    
    
    LM Neuro 2.5/18
    
    
    2.5
    
    
    
    18
    
    
    
    33
    
    
    LM Neuro 2.75/25
    
    
    2.75
    
    
    
    2516
    
    
    LM Neuro 2.0/20
    
    
    2.0
    
    
    
    20
    
    
    
    34
    
    
    LM Neuro 3.0/25
    
    
    3.0
    
    
    
    2517
    
    
    LM Neuro 2.25/20
    
    
    2.25
    
    
    
    20
    
    
    
    35
    
    
    LM Neuro 2.75/30
    
    
    2.75
    
    
    
    3018
    
    
    LM Neuro 2.5/20
    
    
    2.5
    
    
    
    20
    
    
    
    36
    
    
    LM Neuro 3.0/30
    
    
    3.0
    
    
    
    30T4 L-XR
    
    
    
    
    
    T4 XL-XR37
    
    
    LM Neuro 3.5/8
    
    
    3.5
    
    
    
    8
    
    
    
    55
    
    
    LM Neuro 4.5/13
    
    
    4.5
    
    
    
    1338
    
    
    LM Neuro 4.0/8
    
    
    4.0
    
    
    
    8
    
    
    
    56
    
    
    LM Neuro 5.0/13
    
    
    5.0
    
    
    
    1339
    
    
    LM Neuro 3.5/10
    
    
    3.5
    
    
    
    10
    
    
    
    57
    
    
    LM Neuro 4.5/20
    
    
    4.5
    
    
    
    2040
    
    
    LM Neuro 4.0/10
    
    
    4.0
    
    
    
    10
    
    
    
    58
    
    
    LM Neuro 5.0/20
    
    
    5.0
    
    
    
    2041
    
    
    LM Neuro 3.5/13
    
    
    3.5
    
    
    
    13
    
    
    
    59
    
    
    LM Neuro 4.5/30
    
    
    4.5
    
    
    
    3042
    
    
    LM Neuro 4.0/13
    
    
    4.0
    
    
    
    13
    
    
    
    60
    
    
    LM Neuro 5.0/30
    
    
    5.0
    
    
    
    3043
    
    
    LM Neuro 3.5/15
    
    
    3.5
    
    
    
    15
    
    
    
    61
    
    
    LM Neuro 4.5/40
    
    
    4.5
    
    
    
    4044
    
    
    LM Neuro 4.0/15
    
    
    4.0
    
    
    
    15
    
    
    
    62
    
    
    LM Neuro 5.0/40
    
    
    5.0
    
    
    
    4045
    
    
    LM Neuro 3.5/18
    
    
    3.5
    
    
    
    1846
    
    
    LM Neuro 4.0/18
    
    
    4.0
    
    
    
    1847
    
    
    LM Neuro 3.5/20
    
    
    3.5
    
    
    
    2048
    
    
    LM Neuro 4.0/20
    
    
    4.0
    
    
    
    2049
    
    
    LM Neuro 3.5/22
    
    
    3.5
    
    
    
    2250
    
    
    LM Neuro 4.0/22
    
    
    4.0
    
    
    
    2251
    
    
    LM Neuro 3.5/25
    
    
    3.5
    
    
    
    2552
    
    
    LM Neuro 4.0/25
    
    
    4.0
    
    
    
    2553
    
    
    LM Neuro 3.5/30
    
    
    3.5
    
    
    
    3054
    
    
    LM Neuro 4.0/30
    
    
    4.0
    
    
    
    30




---



##### 



8   Product range
  9   Target manufacturing costs
  10  Packaging / Labelling
  11  Sterilisation
 
    
    The sterilization process shall be EO.
    
    The maximum amount of sterilisation cycles shall be two.
    
    The products shall be sterilised twice for biocompatibility and aging tests.
 12  Shelf life
 
    
    The product shelf life shall be three years.
 13  Product compatibility
 13.1  Compatibility with accessories / auxiliary devices
  
    
    SDS compatible with 0.014 (0.36mm) guide wire
    
    Guiding Catheter 5F, min I.D. 0.056 (1.42mm)
 13.2  Compatibility with contrast media




---



##### 



14 Approval
 14.1 Issued by:
 Department / Function
    
    Name
    
    SignatureRD Project Manager
    
    Bernd Ewald
  Department / Function
    
    Name
    
    SignatureQRV Team Member
    
    Karin OrtliebCA Team Member
    
    Marcel SchäferRA Team Member
    
    Marcel SchäferGeneral Manager
    
    Claus Martini




---



##### 



Data Sheet
 Performance Data PHAROS
 Scope
  Mat. No.
    
    Description
    
    Mat. No.
    
    Description
    
    Mat. No.
    
    Description356663
    
    PHAROS 2.0/8
    
    
    356686
    
    
    PHAROS 2.0/15
    
    
    356709
    
    
    PHAROS 2.75/22356664
    
    PHAROS 2.25/8
    
    
    356687
    
    
    PHAROS 2.25/15
    
    
    356710
    
    
    PHAROS 3.0/22356665
    
    PHAROS 2.5/8
    
    
    356688
    
    
    PHAROS 2.5/15
    
    
    356711
    
    
    PHAROS 3.5/22356666
    
    PHAROS 2.75/8
    
    
    356689
    
    
    PHAROS 2.75/15
    
    
    356712
    
    
    PHAROS 4.0/22356667
    
    PHAROS 3.0/8
    
    
    356690
    
    
    PHAROS 3.0/15
    
    
    356713
    
    
    PHAROS 2.75/25356668
    
    PHAROS 3.5/8
    
    
    356691
    
    
    PHAROS 3.5/15
    
    
    356714
    
    
    PHAROS 3.0/25356669
    
    PHAROS 4.0/8
    
    
    356692
    
    
    PHAROS 4.0/15
    
    
    356715
    
    
    PHAROS 3.5/25356670
    
    PHAROS 2.0/10
    
    
    356693
    
    
    PHAROS 2.0/18
    
    
    356716
    
    
    PHAROS 4.0/25356671
    
    PHAROS 2.25/10
    
    
    356694
    
    
    PHAROS 2.25/18
    
    
    356717
    
    
    PHAROS 2.75/30356672
    
    PHAROS 2.5/10
    
    
    356695
    
    
    PHAROS 2.5/18
    
    
    356718
    
    
    PHAROS 3.0/30356673
    
    PHAROS 2.75/10
    
    
    356696
    
    
    PHAROS 2.75/18
    
    
    356719
    
    
    PHAROS 3.5/30356674
    
    PHAROS 3.0/10
    
    
    356697
    
    
    PHAROS 3.0/18
    
    
    356720
    
    
    PHAROS 4.0/30356675
    
    PHAROS 3.5/10
    
    
    356698
    
    
    PHAROS 3.5/18
    
    
    356721
    
    
    PHAROS 4.5/30356676
    
    PHAROS 4.0/10
    
    
    356699
    
    
    PHAROS 4.0/18
    
    
    356722
    
    
    PHAROS 5.0/30356677
    
    PHAROS 2.0/13
    
    
    356700
    
    
    PHAROS 2.0/20
    
    
    356723
    
    
    PHAROS 4.5/40356678
    
    PHAROS 2.25/13
    
    
    356701
    
    
    PHAROS 2.25/20
    
    
    356724
    
    
    PHAROS 5.0/40356679
    
    PHAROS 2.5/13
    
    
    356702
    
    
    PHAROS 2.5/20356680
    
    PHAROS 2.75/13
    
    
    356703
    
    
    PHAROS 2.75/20356681
    
    PHAROS 3.0/13
    
    
    356704
    
    
    PHAROS 3.0/20356682
    
    PHAROS 3.5/13
    
    
    356705
    
    
    PHAROS 3.5/20356683
    
    PHAROS 4.0/13
    
    
    356706
    
    
    PHAROS 4.0/20356684
    
    PHAROS 4.5/13
    
    
    356707
    
    
    PHAROS 4.5/20356685
    
    PHAROS 5.0/13
    
    
    356708
    
    
    PHAROS 5.0/20




---



##### 



Requirements
 Description
    
    ValueGuide wire compatibility
    
    0.014 [inch] (= 0.36 mm)Guiding catheter compatibility
    
    5F, min. ID 0.056 [inch] (= 1.42 mm)Usable length
    
    1400 ±10 [mm]Position of shaft marking
    
    920 ±10 [mm]1020 ±10 [mm]Length of wire lumen
    
    280 ±10 [mm]SDS diameter:Hypotube
    
    2.1 [F]Shaft distal for Ø: 2.0 / 2.25 / 2.5 / 2.75 / 3.0 / 3.5 [mm]
    
    2.6 [F]Shaft distal for Ø: 4.0 [mm]
    
    2.7 [F]Shaft distal for Ø: 4.5/ 5.0 [mm]
    
    2.9 [F]Sterilization Type
    
    EOShelf Life
    
    36 months




---



##### 



Diameter behavior and burst pressure
 Stent
outer diameter [mm]2.0
    
    

2.25
    
    

2.5
    
    

2.75
    
    

3.0Pressure [bar]
    
    Min. 0
    
    
    Nom.-0
    
    
    Max. 0
    
    
    Min. 0
    
    
    Nom.-0
    
    
    Max. 0
    
    
    Min. 0
    
    
    Nom.-0
    
    
    Max. 0
    
    
    Min. 0
    
    
    Nom.-0
    
    
    Max. 0
    
    
    Min. 0
    
    
    Nom.-0
    
    
    Max. 0(-5
%)
    
    
    
    
    

(+5
%)
    
    

(-5
%)
    
    
    
    
    

(+5
%)
    
    

(-5
%)
    
    
    
    
    

(+5
%)
    
    

(-5
%)
    
    
    
    
    

(+5
%)
    
    

(-5
%)
    
    
    
    
    

(+5
%)6
    
    
    1.91
    
    
    
    2.01
    
    
    
    2.11
    
    
    
    2.08
    
    
    
    2.19
    
    
    
    2.30
    
    
    
    2.26
    
    
    
    2.38
    
    
    
    2.50
    
    
    
    2.60
    
    
    
    2.74
    
    
    
    2.88
    
    
    
    2.80
    
    
    
    2.95
    
    
    
    3.107
    
    
    1.94
    
    
    
    2.05
    
    
    
    2.15
    
    
    
    2.13
    
    
    
    2.24
    
    
    
    2.35
    
    
    
    2.32
    
    
    
    2.44
    
    
    
    2.57
    
    
    
    2.66
    
    
    
    2.80
    
    
    
    2.94
    
    
    
    2.86
    
    
    
    3.01
    
    
    
    3.168
    
    
    1.97
    
    
    
    2.08
    
    
    
    2.18
    
    
    
    2.16
    
    
    
    2.28
    
    
    
    2.39
    
    
    
    2.38
    
    
    
    2.50
    
    
    
    2.63
    
    
    
    2.72
    
    
    
    2.86
    
    
    
    3.00
    
    
    
    2.92
    
    
    
    3.07
    
    
    
    3.229
    
    
    2.00
    
    
    
    2.10
    
    
    
    2.21
    
    
    
    2.20
    
    
    
    2.32
    
    
    
    2.43
    
    
    
    2.43
    
    
    
    2.56
    
    
    
    2.68
    
    
    
    2.76
    
    
    
    2.91
    
    
    
    3.05
    
    
    
    2.96
    
    
    
    3.12
    
    
    
    3.2810
    
    
    2.02
    
    
    
    2.12
    
    
    
    2.23
    
    
    
    2.23
    
    
    
    2.35
    
    
    
    2.47
    
    
    
    2.47
    
    
    
    2.60
    
    
    
    2.73
    
    
    
    2.80
    
    
    
    2.95
    
    
    
    3.09
    
    
    
    3.00
    
    
    
    3.16
    
    
    
    3.3211
    
    
    2.04
    
    
    
    2.15
    
    
    
    2.25
    
    
    
    2.26
    
    
    
    2.38
    
    
    
    2.50
    
    
    
    2.51
    
    
    
    2.64
    
    
    
    2.78
    
    
    
    2.84
    
    
    
    2.98
    
    
    
    3.13
    
    
    
    3.04
    
    
    
    3.20
    
    
    
    3.3612
    
    
    2.05
    
    
    
    2.16
    
    
    
    2.27
    
    
    
    2.29
    
    
    
    2.41
    
    
    
    2.53
    
    
    
    2.55
    
    
    
    2.68
    
    
    
    2.81
    
    
    
    2.87
    
    
    
    3.02
    
    
    
    3.17
    
    
    
    3.07
    
    
    
    3.23
    
    
    
    3.4013
    
    
    2.07
    
    
    
    2.18
    
    
    
    2.29
    
    
    
    2.31
    
    
    
    2.43
    
    
    
    2.55
    
    
    
    2.58
    
    
    
    2.71
    
    
    
    2.85
    
    
    
    2.90
    
    
    
    3.05
    
    
    
    3.21
    
    
    
    3.10
    
    
    
    3.27
    
    
    
    3.4314
    
    
    2.09
    
    
    
    2.20
    
    
    
    2.31
    
    
    
    2.33
    
    
    
    2.45
    
    
    
    2.58
    
    
    
    2.60
    
    
    
    2.74
    
    
    
    2.88
    
    
    
    2.93
    
    
    
    3.08
    
    
    
    3.24
    
    
    
    3.14
    
    
    
    3.30
    
    
    
    3.4715
    
    
    2.10
    
    
    
    2.21
    
    
    
    2.32
    
    
    
    2.35
    
    
    
    2.47
    
    
    
    2.60
    
    
    
    2.63
    
    
    
    2.77
    
    
    
    2.91
    
    
    
    2.96
    
    
    
    3.11
    
    
    
    3.37
    
    
    
    3.17
    
    
    
    3.33
    
    
    
    3.5016
    
    
    2.11
    
    
    
    2.22
    
    
    
    2.34
    
    
    
    2.37
    
    
    
    2.50
    
    
    
    2.62
    
    
    
    2.66
    
    
    
    2.80
    
    
    
    2.94
    
    
    
    2.99
    
    
    
    3.15
    
    
    
    3.30
    
    
    
    3.20
    
    
    
    3.37
    
    
    
    3.5417
    
    
    2.12
    
    
    
    2.24
    
    
    
    2.35
    
    
    
    2.39
    
    
    
    2.51
    
    
    
    2.64
    
    
    
    2.69
    
    
    
    2.83
    
    
    
    2.97
    
    
    
    3.02
    
    
    
    3.17
    
    
    
    3.33
    
    
    
    3.23
    
    
    
    3.40
    
    
    
    3.5718
    
    
    2.14
    
    
    
    2.25
    
    
    
    2.36
    
    
    
    2.40
    
    
    
    2.53
    
    
    
    2.66
    
    
    
    2.72
    
    
    
    2.86
    
    
    
    3.00
    
    
    
    3.05
    
    
    
    3.21
    
    
    
    3.37
    
    
    
    3.26
    
    
    
    3.43
    
    
    
    3.61NP =
Nominal Pressure [bar]
    
    
    
    
    
    
    10
    
    
    
    
    
    
    
    
    
    
    
    10
    
    
    
    
    
    
    
    
    
    
    
    10
    
    
    
    
    
    
    
    
    
    
    
    10
    
    
    
    
    
    
    
    
    
    
    
    10RBP =
Rated Burst Pressure [bar]
    
    
    
    
    
    
    16
    
    
    
    
    
    
    
    
    
    
    
    16
    
    
    
    
    
    
    
    
    
    
    
    16
    
    
    
    
    
    
    
    
    
    
    
    16
    
    
    
    
    
    
    
    
    
    
    
    16MAB = Minimum Allowed Burst
[bar] (Warning Limit)
    
    
    
    
    
    
    19
    
    
    
    
    
    
    
    
    
    
    
    19
    
    
    
    
    
    
    
    
    
    
    
    19
    
    
    
    
    
    
    
    
    
    
    
    19
    
    
    
    
    
    
    
    
    
    
    
    19




---



##### 



Diameter behavior and burst pressure
 Stent outer diameter [mm]3.5
    
    
    4.0
    
    
    4.5
    
    
    5.0Pressure [bar]
    
    Min. Ø
    
    
    Nom.-Ø
    
    
    Max. Ø
    
    
    Min. Ø
    
    
    Nom.-Ø
    
    
    Max. Ø
    
    
    Min. Ø
    
    
    Nom.-Ø
    
    
    Max. Ø
    
    
    Min. Ø
    
    
    Nom.-Ø
    
    
    Max. Ø(-5 %)
    
    
    
    
    
    (+5%)
    
    
    (-5 %)
    
    
    
    
    
    (+5 %)
    
    
    (-5 %)
    
    
    
    
    
    (+5 %)
    
    
    (-5%)
    
    
    
    
    
    (+5 %)6
    
    
    3.33
    
    
    
    3.50
    
    
    
    3.68
    
    
    
    3.74
    
    
    
    3.93
    
    
    
    4.13
    
    
    
    4.18
    
    
    
    4.40
    
    
    
    4.62
    
    
    
    4.52
    
    
    
    4.75
    
    
    
    4.997
    
    
    3.39
    
    
    
    3.57
    
    
    
    3.75
    
    
    
    3.82
    
    
    
    4.02
    
    
    
    4.22
    
    
    
    4.27
    
    
    
    4.50
    
    
    
    4.72
    
    
    
    4.63
    
    
    
    4.87
    
    
    
    5.128
    
    
    3.44
    
    
    
    3.63
    
    
    
    3.81
    
    
    
    3.89
    
    
    
    4.10
    
    
    
    4.30
    
    
    
    4.36
    
    
    
    4.58
    
    
    
    4.81
    
    
    
    4.73
    
    
    
    4.98
    
    
    
    5.239
    
    
    3.49
    
    
    
    3.67
    
    
    
    3.86
    
    
    
    3.95
    
    
    
    4.16
    
    
    
    4.36
    
    
    
    4.41
    
    
    
    4.64
    
    
    
    4.88
    
    
    
    4.83
    
    
    
    5.09
    
    
    
    5.3410
    
    
    3.53
    
    
    
    3.72
    
    
    
    3.90
    
    
    
    4.00
    
    
    
    4.21
    
    
    
    4.42
    
    
    
    4.47
    
    
    
    4.71
    
    
    
    4.95
    
    
    
    4.90
    
    
    
    5.16
    
    
    
    5.4211
    
    
    3.57
    
    
    
    3.76
    
    
    
    3.95
    
    
    
    4.05
    
    
    
    4.26
    
    
    
    4.47
    
    
    
    4.51
    
    
    
    4.75
    
    
    
    4.99
    
    
    
    4.95
    
    
    
    5.21
    
    
    
    5.4812
    
    
    3.61
    
    
    
    3.80
    
    
    
    3.98
    
    
    
    4.09
    
    
    
    4.31
    
    
    
    4.52
    
    
    
    4.55
    
    
    
    4.79
    
    
    
    5.03
    
    
    
    5.01
    
    
    
    5.27
    
    
    
    5.5413
    
    
    3.64
    
    
    
    3.83
    
    
    
    4.02
    
    
    
    4.13
    
    
    
    4.35
    
    
    
    4.56
    
    
    
    4.59
    
    
    
    4.84
    
    
    
    5.08
    
    
    
    5.06
    
    
    
    5.32
    
    
    
    5.5914
    
    
    3.67
    
    
    
    3.87
    
    
    
    4.06
    
    
    
    4.17
    
    
    
    4.39
    
    
    
    4.61
    
    
    
    4.64
    
    
    
    4.88
    
    
    
    5.12
    
    
    
    5.11
    
    
    
    5.38
    
    
    
    5.6415
    
    
    3.71
    
    
    
    3.90
    
    
    
    4.10
    
    
    
    4.21
    
    
    
    4.43
    
    
    
    4.65
    
    
    
    4.67
    
    
    
    4.92
    
    
    
    5.17
    
    
    
    5.16
    
    
    
    5.43
    
    
    
    5.7016
    
    
    3.74
    
    
    
    3.94
    
    
    
    4.14
    
    
    
    4.25
    
    
    
    4.47
    
    
    
    4.69
    
    
    
    4.71
    
    
    
    4.96
    
    
    
    5.21
    
    
    
    5.21
    
    
    
    5.48
    
    
    
    5.7617
    
    
    3.78
    
    
    
    3.98
    
    
    
    4.18
    
    
    
    4.29
    
    
    
    4.51
    
    
    
    4.74
    
    
    
    4.75
    
    
    
    5.00
    
    
    
    5.25
    
    
    
    5.25
    
    
    
    5.53
    
    
    
    5.8118
    
    
    3.82
    
    
    
    4.02
    
    
    
    4.23
    
    
    
    4.33
    
    
    
    4.56
    
    
    
    4.79
    
    
    
    4.80
    
    
    
    5.05
    
    
    
    5.30
    
    
    
    5.30
    
    
    
    5.58
    
    
    
    5.86NP = Nominal Pressure [bar]
    
    
    
    
    
    
    10
    
    
    
    
    
    
    
    
    
    
    
    10
    
    
    
    
    
    
    
    
    
    
    
    10
    
    
    
    
    
    
    
    
    
    
    
    10RBP = Rated Burst Pressure [bar]
    
    
    
    
    
    
    16
    
    
    
    
    
    
    
    
    
    
    
    16
    
    
    
    
    
    
    
    
    
    
    
    16
    
    
    
    
    
    
    
    
    
    
    
    16MAB = Minimum Allowed Burst [bar] (Warning Limit)
    
    
    
    
    
    
    19
    
    
    
    
    
    
    
    
    
    
    
    19
    
    
    
    
    
    
    
    
    
    
    
    19
    
    
    
    
    
    
    
    
    
    
    
    19




---



##### 



Performance data
 Material / Description
    
    
    Balloon
    
    
    Stent Retention Force
    
    
    Stent Geometry
    
    
    Tensile Strength /Deflation Time
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    Warning LimitMaterial-No.
    
    Balloon
    
    
    Stent length
    
    
    Glycerine mix
    
    
    Warning
    
    
    Rated Stent
    
    
    Diameter when
    
    
    Length whendiameter
    
    
    
    
    
    
    30/70 %
    
    
    Limit
    
    
    Retention Force
    
    
    crimped
    
    
    crimped(γ = 0.95/p = 0.95)[mm]
    
    
    [mm]
    
    t max[s]
    
    F min. [N]
    
    
    
    [mm]
    
    [mm]
    
    

    F min. [N]356663
    
    
    2.0
    
    
    
    8
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.88 +0.05 / 0.08
    
    
    
    8.3 ±0.20356664
    
    
    2.25
    
    
    
    8
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.89 +0.05 / 0.08
    
    
    
    8.3 ±0.20356665
    
    
    2.5
    
    
    
    8
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.90 +0.05 / 0.08
    
    
    
    8.3 ±0.20356666
    
    
    2.75
    
    
    
    8
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.98 +0.05 / 0.08
    
    
    
    8.3 ±0.20356667
    
    
    3.0
    
    
    
    8
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.99 +0.05 / 0.08
    
    
    
    8.3 ±0.20356668
    
    
    3.5
    
    
    
    8
    
    
    
    20
    
    
    
    2.0
    
    
    
    1.0
    
    
    
    1.06 +0.05 / 0.08
    
    
    
    8.1 ±0.20356669
    
    
    4.0
    
    
    
    8
    
    
    
    20
    
    
    
    2.0
    
    
    
    1.0
    
    
    
    1.08 +0.05 / 0.08
    
    
    
    8.1 ±0.20356670
    
    
    2.0
    
    
    
    10
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.88 +0.05 / 0.08
    
    
    
    10.3 ±0.20356671
    
    
    2.25
    
    
    
    10
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.89 +0.05 / 0.08
    
    
    
    10.3 ±0.20356672
    
    
    2.5
    
    
    
    10
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.90 +0.05 / 0.08
    
    
    
    10.3 ±0.20356673
    
    
    2.75
    
    
    
    10
    
    
    
    20
    
    
    
    2.0
    
    
    
    1.5
    
    
    
    0.98 +0.05 / 0.08
    
    
    
    10.3 ±0.20356674
    
    
    3.0
    
    
    
    10
    
    
    
    20
    
    
    
    2.0
    
    
    
    1.5
    
    
    
    0.99 +0.05 / 0.08
    
    
    
    10.3 ±0.20
    
    
    
    5.0 / 7.0356675
    
    
    3.5
    
    
    
    10
    
    
    
    20
    
    
    
    2.5
    
    
    
    1.5
    
    
    
    1.06 +0.05 / 0.08
    
    
    
    9.8 ±0.20356676
    
    
    4.0
    
    
    
    10
    
    
    
    20
    
    
    
    2.5
    
    
    
    1.5
    
    
    
    1.08 +0.05 / 0.08
    
    
    
    9.8 ±0.20356677
    
    
    2.0
    
    
    
    13
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.88 +0.05 / 0.08
    
    
    
    13.0 ±0.20356678
    
    
    2.25
    
    
    
    13
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.89 +0.05 / 0.08
    
    
    
    13.0 ±0.20356679
    
    
    2.5
    
    
    
    13
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.90 +0.05 / 0.08
    
    
    
    13.0 ±0.20356680
    
    
    2.75
    
    
    
    13
    
    
    
    20
    
    
    
    2.0
    
    
    
    1.5
    
    
    
    0.98 +0.05 / 0.08
    
    
    
    12.8 ±0.20356681
    
    
    3.0
    
    
    
    13
    
    
    
    20
    
    
    
    2.0
    
    
    
    1.5
    
    
    
    0.99 +0.05 / 0.08
    
    
    
    12.8 ±0.20356682
    
    
    3.5
    
    
    
    13
    
    
    
    20
    
    
    
    2.5
    
    
    
    1.5
    
    
    
    1.06 +0.05 / 0.08
    
    
    
    12.8 ±0.20356683
    
    
    4.0
    
    
    
    13
    
    
    
    20
    
    
    
    2.5
    
    
    
    1.5
    
    
    
    1.08 +0.05 / 0.08
    
    
    
    12.8 ±0.20356684
    
    
    4.5
    
    
    
    13
    
    
    
    20
    
    
    
    3.5
    
    
    
    2.5
    
    
    
    1.22 ±0.08
    
    
    
    13.0 ±0.20356685
    
    
    5.0
    
    
    
    13
    
    
    
    30
    
    
    
    3.5
    
    
    
    2.5
    
    
    
    1.26 ±0.08
    
    
    
    13.0 ±0.20




---



##### 



Performance data
 Material / Description
    
    
    Balloon
    
    
    Stent Retention Force
    
    
    Stent Geometry
    
    
    Tensile Strength /Deflation Time
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    Warning LimitMaterial-No.
    
    Balloon
    
    
    Stent length
    
    
    Glycerine mix
    
    
    Warning
    
    
    Rated Stent
    
    
    Diameter when
    
    
    Length whendiameter
    
    
    
    
    
    
    30/70 %
    
    
    Limit
    
    
    Retention Force
    
    
    crimped
    
    
    crimped(γ = 0.95/p = 0.95)[mm]
    
    
    [mm]
    
    t max[s]
    
    F min. [N]
    
    
    
    [mm]
    
    [mm]
    
    

    F min. [N]356686
    
    
    2.0
    
    
    
    15
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.88 +0.05 / 0.08
    
    
    
    15.0 ±0.20356687
    
    
    2.25
    
    
    
    15
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.89 +0.05 / 0.08
    
    
    
    15.0 ±0.20356688
    
    
    2.5
    
    
    
    15
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.90 +0.05 / 0.08
    
    
    
    15.0 ±0.20356689
    
    
    2.75
    
    
    
    15
    
    
    
    20
    
    
    
    2.0
    
    
    
    1.5
    
    
    
    0.98 +0.05 / 0.08
    
    
    
    14.8 ±0.20356690
    
    
    3.0
    
    
    
    15
    
    
    
    20
    
    
    
    2.0
    
    
    
    1.5
    
    
    
    0.99 +0.05 / 0.08
    
    
    
    14.8 ±0.20356691
    
    
    3.5
    
    
    
    15
    
    
    
    20
    
    
    
    2.5
    
    
    
    1.5
    
    
    
    1.06 +0.05 / 0.08
    
    
    
    14.5 ±0.20356692
    
    
    4.0
    
    
    
    15
    
    
    
    20
    
    
    
    2.5
    
    
    
    1.5
    
    
    
    1.08 +0.05 / 0.08
    
    
    
    14.5 ±0.20356693
    
    
    2.0
    
    
    
    18
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.88 +0.05 / 0.08
    
    
    
    18.1 ±0.20356694
    
    
    2.25
    
    
    
    18
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.89 +0.05 / 0.08
    
    
    
    18.1 ±0.20356695
    
    
    2.5
    
    
    
    18
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.90 +0.05 / 0.08
    
    
    
    18.1 ±0.20356696
    
    
    2.75
    
    
    
    18
    
    
    
    20
    
    
    
    2.0
    
    
    
    1.5
    
    
    
    0.98 +0.05 / 0.08
    
    
    
    18.1 ±0.20356697
    
    
    3.0
    
    
    
    18
    
    
    
    20
    
    
    
    2.0
    
    
    
    1.5
    
    
    
    0.99 +0.05 / 0.08
    
    
    
    18.1 ±0.20
    
    
    
    5.0 / 7.0356698
    
    
    3.5
    
    
    
    18
    
    
    
    20
    
    
    
    2.5
    
    
    
    1.5
    
    
    
    1.06 +0.05 / 0.08
    
    
    
    18.1 ±0.20356699
    
    
    4.0
    
    
    
    18
    
    
    
    20
    
    
    
    2.5
    
    
    
    1.5
    
    
    
    1.08 +0.05 / 0.08
    
    
    
    18.1 ±0.20356700
    
    
    2.0
    
    
    
    20
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.88 +0.05 / 0.08
    
    
    
    20.0 ±0.30356701
    
    
    2.25
    
    
    
    20
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.89 +0.05 / 0.08
    
    
    
    20.0 ±0.30356702
    
    
    2.5
    
    
    
    20
    
    
    
    20
    
    
    
    1.5
    
    
    
    1.0
    
    
    
    0.90 +0.05 / 0.08
    
    
    
    20.0 ±0.30356703
    
    
    2.75
    
    
    
    20
    
    
    
    20
    
    
    
    2.0
    
    
    
    1.5
    
    
    
    0.98 +0.05 / 0.08
    
    
    
    20.0 ±0.30356704
    
    
    3.0
    
    
    
    20
    
    
    
    20
    
    
    
    2.0
    
    
    
    1.5
    
    
    
    0.99 +0.05 / 0.08
    
    
    
    20.0 ±0.30356705
    
    
    3.5
    
    
    
    20
    
    
    
    20
    
    
    
    2.5
    
    
    
    1.5
    
    
    
    1.06 +0.05 / 0.08
    
    
    
    19.8 ±0.30356706
    
    
    4.0
    
    
    
    20
    
    
    
    20
    
    
    
    2.5
    
    
    
    1.5
    
    
    
    1.08 +0.05 / 0.08
    
    
    
    19.8 ±0.30356707
    
    
    4.5
    
    
    
    20
    
    
    
    20
    
    
    
    3.5
    
    
    
    3.0
    
    
    
    1.22 ±0.08
    
    
    
    19.1 ±0.30356708
    
    
    5.0
    
    
    
    20
    
    
    
    30
    
    
    
    3.5
    
    
    
    3.0
    
    
    
    1.26 ±0.08
    
    
    
    19.1 ±0.30




---



##### 



Performance data
 Material / Description
    
    
    Balloon
    
    
    Stent Retention Force
    
    
    Stent Geometry
    
    
    Tensile Strength /Deflation Time
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    Warning LimitMaterial-No.
    
    Balloon
    
    
    Stent length
    
    
    Glycerine mix
    
    
    Warning
    
    
    Rated Stent
    
    
    Diameter when
    
    
    Length whendiameter
    
    
    
    
    
    
    30/70 %
    
    
    Limit
    
    
    Retention Force
    
    
    crimped
    
    
    crimped(γ = 0.95/p = 0.95)[mm]
    
    
    [mm]
    
    t max[s]
    
    F min. [N]
    
    
    
    [mm]
    
    [mm]
    
    

    F min. [N]356709
    
    
    2.75
    
    
    
    22
    
    
    
    20
    
    
    
    2.0
    
    
    
    1.5
    
    
    
    0.98 +0.05 / 0.08
    
    
    
    22.3 ±0.30356710
    
    
    3.0
    
    
    
    22
    
    
    
    20
    
    
    
    2.0
    
    
    
    1.5
    
    
    
    0.99 +0.05 / 0.08
    
    
    
    22.3 ±0.30356711
    
    
    3.5
    
    
    
    22
    
    
    
    20
    
    
    
    2.5
    
    
    
    1.5
    
    
    
    1.06 +0.05 / 0.08
    
    
    
    22.3 ±0.30356712
    
    
    4.0
    
    
    
    22
    
    
    
    20
    
    
    
    2.5
    
    
    
    1.5
    
    
    
    1.08 +0.05 / 0.08
    
    
    
    22.3 ±0.30356713
    
    
    2.75
    
    
    
    25
    
    
    
    20
    
    
    
    2.0
    
    
    
    1.5
    
    
    
    0.98 +0.05 / 0.08
    
    
    
    24.5 ±0.30356714
    
    
    3.0
    
    
    
    25
    
    
    
    20
    
    
    
    2.0
    
    
    
    1.5
    
    
    
    0.99 +0.05 / 0.08
    
    
    
    24.5 ±0.30356715
    
    
    3.5
    
    
    
    25
    
    
    
    20
    
    
    
    2.5
    
    
    
    1.5
    
    
    
    1.06 +0.05 / 0.08
    
    
    
    24.5 ±0.30356716
    
    
    4.0
    
    
    
    25
    
    
    
    20
    
    
    
    2.5
    
    
    
    1.5
    
    
    
    1.08 +0.05 / 0.08
    
    
    
    24.5 ±0.30
    
    
    
    5.0 / 7.0356717
    
    
    2.75
    
    
    
    30
    
    
    
    20
    
    
    
    2.0
    
    
    
    1.5
    
    
    
    0.98 +0.05 / 0.08
    
    
    
    29.6 ±0.30356718
    
    
    3.0
    
    
    
    30
    
    
    
    20
    
    
    
    2.0
    
    
    
    1.5
    
    
    
    0.99 +0.05 / 0.08
    
    
    
    29.6 ±0.30356719
    
    
    3.5
    
    
    
    30
    
    
    
    20
    
    
    
    2.5
    
    
    
    1.5
    
    
    
    1.06 +0.05 / 0.08
    
    
    
    29.2 ±0.30356720
    
    
    4.0
    
    
    
    30
    
    
    
    20
    
    
    
    2.5
    
    
    
    1.5
    
    
    
    1.08 +0.05 / 0.08
    
    
    
    29.2 ±0.30356721
    
    
    4.5
    
    
    
    30
    
    
    
    20
    
    
    
    3.5
    
    
    
    3.0
    
    
    
    1.22 ±0.08
    
    
    
    29.8 ±0.30356722
    
    
    5.0
    
    
    
    30
    
    
    
    30
    
    
    
    3.5
    
    
    
    3.0
    
    
    
    1.26 ±0.08
    
    
    
    29.8 ±0.30356723
    
    
    4.5
    
    
    
    40
    
    
    
    20
    
    
    
    3.5
    
    
    
    3.0
    
    
    
    1.22 ±0.08
    
    
    
    39.0 ±0.30356724
    
    
    5.0
    
    
    
    40
    
    
    
    30
    
    
    
    3.5
    
    
    
    3.0
    
    
    
    1.26 ±0.08
    
    
    
    39.0 ±0.30




---



##### 



Feb-06
    
    

Mar-06
    
    
    1Q2006
    
    
    Apr-06
    
    
    May-06
    
    
    Jun-06Manufacturing Forecast by Sizes (Includes non-sterile demo units + units needed so that appropriate si2.25 x 8mm
    
    
    
    
    
    
    
    
    
    
    0
    
    
    
    
    
    
    
    
    
    
    
    02.5 x 8mm
    
    
    2
    
    
    
    1
    
    
    
    3
    
    
    
    10
    
    
    
    1
    
    
    
    12.75 x 8mm
    
    
    2
    
    
    
    2
    
    
    
    4
    
    
    
    10
    
    
    
    4
    
    
    
    13.0 x 8mm
    
    
    2
    
    
    
    2
    
    
    
    4
    
    
    
    10
    
    
    
    4
    
    
    
    13.5 x 8mm
    
    
    2
    
    
    
    2
    
    
    
    4
    
    
    
    10
    
    
    
    4
    
    
    
    14.0 x 8mm
    
    
    
    
    
    
    
    
    
    
    02.25 x 10mm
    
    
    
    
    
    
    
    
    
    
    02.5 x 10mm
    
    
    2
    
    
    
    1
    
    
    
    3
    
    
    
    7
    
    
    
    1
    
    
    
    12.75 x 10mm
    
    
    2
    
    
    
    1
    
    
    
    3
    
    
    
    7
    
    
    
    4
    
    
    
    13.0 x 10mm
    
    
    2
    
    
    
    1
    
    
    
    3
    
    
    
    7
    
    
    
    4
    
    
    
    13.5 x 10mm
    
    
    2
    
    
    
    1
    
    
    
    3
    
    
    
    7
    
    
    
    1
    
    
    
    14.0 x 10mm
    
    
    
    
    
    
    
    
    
    
    0
    
    
    
    7
    
    
    
    1
    
    
    
    12.25 x 13mm
    
    
    
    
    
    
    
    
    
    
    02.5 x 13mm
    
    
    1
    
    
    
    1
    
    
    
    2
    
    
    
    7
    
    
    
    1
    
    
    
    12.75 x 13mm
    
    
    2
    
    
    
    1
    
    
    
    3
    
    
    
    7
    
    
    
    3
    
    
    
    13.0 x 13mm
    
    
    2
    
    
    
    1
    
    
    
    3
    
    
    
    7
    
    
    
    3
    
    
    
    13.5 x 13mm
    
    
    1
    
    
    
    1
    
    
    
    2
    
    
    
    7
    
    
    
    3
    
    
    
    14.0 x 13mm
    
    
    
    
    
    
    
    
    
    
    02.5 x 15mm
    
    
    1
    
    
    
    1
    
    
    
    2
    
    
    
    7
    
    
    
    1
    
    
    
    13.0 x 15mm
    
    
    2
    
    
    
    1
    
    
    
    3
    
    
    
    7
    
    
    
    1
    
    
    
    13.5 x 15mm
    
    
    2
    
    
    
    1
    
    
    
    3
    
    
    
    7
    
    
    
    1
    
    
    
    13.5 x 18mm
    
    
    2
    
    
    
    1
    
    
    
    3
    
    
    
    7
    
    
    
    1
    
    
    
    14.0 x 18mm
    
    
    1
    
    
    
    1
    
    
    
    2
    
    
    
    
    
    
    
    1
    
    
    
    1LM Neuro  Total (all non-rev)
    
    
    30
    
    
    
    20
    
    
    
    50
    
    
    
    0
    
    
    
    0
    
    
    
    0LM Blue  Total
    
    
    0
    
    
    
    0
    
    
    
    0
    
    
    
    131
    
    
    
    39
    
    
    
    18




---



##### 



2Q2006
    
    Jul-06
    
    

Aug-06
    
    
    Sep-06
    
    
    3Q2006
    
    
    Oct-06
    
    

Nov-06
    
    
    Dec-06
    
    
    4Q2006zing is possible)0
    
    
    1
    
    
    
    1
    
    
    
    2
    
    
    
    4
    
    
    
    2
    
    
    
    2
    
    
    
    2
    
    
    
    612
    
    
    5
    
    
    
    2
    
    
    
    2
    
    
    
    9
    
    
    
    6
    
    
    
    5
    
    
    
    5
    
    
    
    1615
    
    
    6
    
    
    
    3
    
    
    
    2
    
    
    
    11
    
    
    
    6
    
    
    
    5
    
    
    
    5
    
    
    
    1615
    
    
    6
    
    
    
    3
    
    
    
    2
    
    
    
    11
    
    
    
    6
    
    
    
    5
    
    
    
    5
    
    
    
    1615
    
    
    5
    
    
    
    3
    
    
    
    2
    
    
    
    10
    
    
    
    6
    
    
    
    4
    
    
    
    4
    
    
    
    140
    
    
    1
    
    
    
    1
    
    
    
    1
    
    
    
    3
    
    
    
    1
    
    
    
    1
    
    
    
    1
    
    
    
    30
    
    
    1
    
    
    
    1
    
    
    
    1
    
    
    
    3
    
    
    
    1
    
    
    
    1
    
    
    
    1
    
    
    
    39
    
    
    5
    
    
    
    2
    
    
    
    2
    
    
    
    9
    
    
    
    6
    
    
    
    5
    
    
    
    5
    
    
    
    1612
    
    
    6
    
    
    
    3
    
    
    
    2
    
    
    
    11
    
    
    
    6
    
    
    
    5
    
    
    
    5
    
    
    
    1612
    
    
    6
    
    
    
    3
    
    
    
    2
    
    
    
    11
    
    
    
    6
    
    
    
    5
    
    
    
    5
    
    
    
    169
    
    
    5
    
    
    
    3
    
    
    
    2
    
    
    
    10
    
    
    
    6
    
    
    
    5
    
    
    
    5
    
    
    
    169
    
    
    1
    
    
    
    1
    
    
    
    1
    
    
    
    3
    
    
    
    1
    
    
    
    1
    
    
    
    1
    
    
    
    30
    
    
    1
    
    
    
    1
    
    
    
    1
    
    
    
    3
    
    
    
    1
    
    
    
    1
    
    
    
    1
    
    
    
    39
    
    
    4
    
    
    
    1
    
    
    
    1
    
    
    
    6
    
    
    
    6
    
    
    
    5
    
    
    
    5
    
    
    
    1611
    
    
    5
    
    
    
    1
    
    
    
    1
    
    
    
    7
    
    
    
    6
    
    
    
    5
    
    
    
    5
    
    
    
    1611
    
    
    5
    
    
    
    1
    
    
    
    1
    
    
    
    7
    
    
    
    6
    
    
    
    5
    
    
    
    5
    
    
    
    1611
    
    
    4
    
    
    
    1
    
    
    
    1
    
    
    
    6
    
    
    
    6
    
    
    
    5
    
    
    
    5
    
    
    
    160
    
    
    1
    
    
    
    1
    
    
    
    1
    
    
    
    3
    
    
    
    1
    
    
    
    1
    
    
    
    1
    
    
    
    39
    
    
    2
    
    
    
    1
    
    
    
    1
    
    
    
    4
    
    
    
    2
    
    
    
    2
    
    
    
    2
    
    
    
    69
    
    
    2
    
    
    
    1
    
    
    
    1
    
    
    
    4
    
    
    
    2
    
    
    
    2
    
    
    
    2
    
    
    
    69
    
    
    2
    
    
    
    1
    
    
    
    1
    
    
    
    4
    
    
    
    2
    
    
    
    2
    
    
    
    2
    
    
    
    69
    
    
    2
    
    
    
    1
    
    
    
    1
    
    
    
    4
    
    
    
    2
    
    
    
    2
    
    
    
    2
    
    
    
    62
    
    
    1
    
    
    
    1
    
    
    
    1
    
    
    
    3
    
    
    
    1
    
    
    
    1
    
    
    
    1
    
    
    
    30
    
    
    0
    
    
    
    0
    
    
    
    0
    
    
    
    0
    
    
    
    0
    
    
    
    0
    
    
    
    0
    
    
    
    0188
    
    
    77
    
    
    
    37
    
    
    
    32
    
    
    
    146
    
    
    
    88
    
    
    
    75
    
    
    
    75
    
    
    
    238




---



##### 



1Q2007
    
    2Q2007
    
    
    3Q2007
    
    
    4Q2007
    
    
    1Q2008
    
    
    2Q2008
    
    
    3Q2008
    
    
    4Q2008