P-000078 REV 1 08/22

Glaukos® Corporation iStent infinite®
Trabecular Micro-Bypass System
Instructions for Use
DIRECTIONS FOR USE TABLE OF CONTENTS
1.

DEVICE DESCRIPTION

2.

INDICATIONS FOR USE

3.

CONTRAINDICATIONS4.

WARNINGS

5.

PRECAUTIONS

6.

ADVERSE REACTIONS

7.

INSTRUCTIONS FOR USE

8.

ADVERSE EVENT REPORTING9.

HOW SUPPLIED

10. STORAGE REQUIREMENTS
11. EXPIRATION DATE
12. RETURN GOODS POLICY
13. iSTENT INFINITE SYSTEM -PIVOTAL CLINICAL TRIAL RESULTS
14. LABELING
15. MRI SAFETY INFORMATION
16. CAUTION
1. DEVICE DESCRIPTION
The iStent infinite® Trabecular Micro-Bypass System, Model iS3 contains three
preloaded intraocular stents (Model G2-W) that are manufactured from implant
grade titanium (Ti6Al4V ELI) and are coated with stearalkonium heparin (note: theheparin is from a porcine source). The stent has a single piece design, is 360 µm in
diameter, 360 µm in height, and the central inlet and outlet lumen has a diameterof 80 µm (Figure 1). The head of the stent has four side outlets that each have adiameter of 50 µm.

Figure 1. iStent infinite Stent Dimensions
The iStent infinite stent has a rear flange which resides in the anterior chamber,and head that resides in Schlemm’s canal. The thorax of the stent is retainedby the trabecular meshwork. The stent is symmetrical and is designed to be
implanted in either the left or right eye (Figure 2). Three preloaded intraocular
stents are provided in the injector (Figures 3a & 3b).

Figure 2. iStent infinite Stent (Model G2-W Stent)

Figure 3a. iStent infinite Injector Design

Important Notes:• If a stent is under implanted and remains on the trocar, do not actuate thesingulator; re-attempt stent implantation in the nearest available trabecularmeshwork tissue (within 1/2 clock hour away); see Figure 9• If a stent is under implanted and remains on the trocar and the singulator wasthen actuated (i.e., two stents visible on the trocar), use an alternative “flush
technique”procedure to re-attempt stent implantation in the nearest available
trabecular meshwork tissue (within 1/2 clock hour away); see Figure 9.
• If a stent is under implanted and does not remain on trocar, the stent can be“rethreaded” by placing the trocar through the central inlet (Figure 9). Use theappropriate tissue pressure technique, “dimple technique” if one stent is on
the trocar or the “flush technique” if two stents are visible on the trocar.

pre-loaded configuration allowing for precise implantation into Schlemm’s canal.
The injector has been designed by Glaukos® Corporation to hold three stents tobe implanted one at a time into Schlemm’s canal.
2. INDICATIONS FOR USE
The iStent infinite Trabecular Micro-Bypass System Model iS3 is an implantabledevice intended to reduce the intraocular pressure (IOP) of the eye. It is indicatedfor use in adult patients with primary open-angle glaucoma in whom previous
medical and surgical treatment has failed.
3. CONTRAINDICATIONS
The iStent infinite Trabecular Micro-Bypass System is contraindicated under thefollowing circumstances or conditions:• In eyes with angle closure glaucoma where angle has not been surgically
opened• In eyes with acute traumatic, malignant, active uveitic, or active neovascularglaucoma or discernible congenital anomalies of the anterior chamber (AC)angle
• In patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber
Syndrome or any other type of condition that may cause elevated episcleralvenous pressure

flush technique

6. ADVERSE REACTIONS
Refer to the Pivotal Clinical Trial Results section for the adverse events that
occurred in the pivotal clinical trial. Additional adverse events that may possibly
be associated with the use of the device include but are not limited to thefollowing: allergic reaction, aqueous misdirection, atrophy/phthisis, choroidal
effusion, choroidal hemorrhage, chronic pain, corneal decompensation, corneal
injury, corneal opacification, cyclodialysis cleft, damage to crystalline lens,damage to iris, damage to trabecular meshwork, device malfunction identified
after entry of the injector system into the eye but prior to contact with the target
tissue, failure to implant 3 stents, flat or shallow anterior chamber, hypopyon,
hypotony maculopathy, inadvertent perforation of the sclera, infection, IOL
damage/dislocation, iridodialysis, loss of eye, loss of stent in eye, loss of vitreous,perforation of sclera, posterior capsular bag rupture or tear, proliferative
vitreoretinopathy, ptosis, pupillary block, pupillary membrane formation, retinal
detachment, retinal dialysis, retinal flap tears, secondary surgical intervention,
including but not limited to glaucoma surgery, premature stent release, stentdislocation, stent explant, stent migration, stent-cornea touch, stent not
retrievable, stent not visible, over implanted stents that are not visible withgonioscopy, Toxic Anterior Segment Syndrome (TASS), and vitreous hemorrhage.
7. INSTRUCTIONS FOR USE
The iStent infinite injector is intended for placement through a clear corneal
incision after the implantation site has been confirmed through adequate
visualization of the anterior chamber angle. The stent implantations are designed
for nasal placement; therefore, it is suggested that surgery is performed from thetemporal side of the head. An intracameral miotic can be injected to deepen theangle prior to placement of the iStent infinite stent. To mitigate difficulty withpatient movement or non-compliance, consider using a peri-bulbar or retrobulbar block.
1) Prepare the eye and implant site for proper visualization of the trabecularmeshwork (TM) using the operating microscope and gonioprism as follows:a. Instill a miotic, as needed in order to achieve good visualization, up to twohours prior to the procedure.
b. Tilt the patient’s head away from the surgeon (about 15-25°).
c. Tilt the surgical microscope back toward the surgeon (about 35°). Total
angle should be approximately 50-60° for both the patient and microscopetilts to achieve the ideal view.
d. Place a small amount of viscoelastic on the cornea. Position the gonioprismon the cornea using light touch gonioscopy.
e. Adjust the microscope to locate and focus on the TM.
f. Inspect AC angle structures with a gonioprism to ensure that a good view isavailable at the nasal implant location. Identify the 3 targets approximately
2 clock hours apart for best implantation of the stents, See Figure 4.

••

Postoperative Instructions
1. Patients should be managed postoperatively for IOP increases that may
occur in the early postoperative period as a possible sequela in patients withglaucoma. Additionally, monitor the patient postoperatively and consider anappropriate treatment regimen to reduce intraocular pressure if need be.
2. Gonioscopy should be performed to assess the iStent infinite stent position
postoperatively.
3. Ultrasound biomicroscopy (UBM) is a useful adjunctive diagnostic aid in caseof poor visualization of stents via gonioscopy.
4. Variations in gonioscopic visualization and limitations of UBM may prevent
localization of a stent. However, in the absence of clinical sequelae, device
adjustment or removal is not recommended.
5. It is highly recommended that Glaukos be contacted prior to postoperative
device removal.

Figure 5b. Hand position on injector when pressing Singulator
2) Prepare for and perform surgery
a. Standard ophthalmic surgery techniques should be used to prepare thepatient and the eye.
b. Make a clear corneal incision of adequate length to allow entry of theintroducer tip of the injector into the anterior chamber. Recommended
incision location is the temporal peripheral cornea for either eye.
c. Ophthalmic viscoelastic (cohesive) should be used to form the anteriorchamber, as necessary. Deepen the anterior chamber by injecting withviscoelastic as needed, being careful not to overinflate.
3) The iStent infinite injector insertion steps are as follows:a. With the gonioprism removed from the cornea, insert the injector
introducer tip through the clear corneal incision into the anterior chamber,and advance it to the pupillary margin toward the targeted trabecularmeshwork tissue (i.e., the ab interno approach). Take care to avoid contact
with the lens, iris, or cornea.
b. Place the gonioprism on the cornea and position the patient and surgicalmicroscope as needed to visualize the trabecular meshwork through thegonioprism on the nasal side of the eye. Focus on the landmarks in theangle of the eye (Figures 6a & 6b). Look up from the iris root to find thescleral spur (white line). Then look for Schwalbe’s line (white line) downfrom the cornea. The trabecular meshwork (typically a red/brown line) is
between the scleral spur and Schwalbe’s line. Schlemm’s canal is behind
the trabecular meshwork.

Figure 6a. iStent infinite Implant Site

Figure 6b. iStent infinite Implant Site

Figure 7. iStent infinite Implant Procedure(left: approach the TM; center: trocar pierces TM;
right: dimple tissue and deploy stent)
e. Looking through the window in the insertion tube, ensure the trocar
remains centered in the insertion tube.
f. Slowly squeeze and hold down the implantation button to automaticallyinject the stent head through the TM and into Schlemm’s canal.
g. Look through the window in the insertion tube to verify the stent has been
implanted properly. When the stent is implanted properly, the head of
the conical portion of the stent should reside fully within Schlemm’s canal
while the stent’s wide flange remains visible on the surface of the TM in theanterior chamber.
h. Withdraw the injector straight back from the stent.
i. Verify that the stent is well-positioned and secured in the TM.
j. Actuate the Singulator to prepare the next stent for implantation. Listen for
the two audible clicks, and verify that the next stent is visible in the windowof the insertion tube.
k. Carefully relocate the tip of the injector approximately 2 clock hours awayfrom the first stent for implantation of the second stent. Implant the next
stent using the same procedure as the previous stent.
l. Repeat the previous step for the third stent, placing the third stent
approximately 2 clock hours away from either of the first two stents. Note:it may be desirable to exit the eye after the first or second stent implant.
Ensure comfortable surgeon positioning and angle of approach to target
stent implant site prior to subsequent stent implantations.
4) Intraoperative confirmation of proper stent positioning is as follows:a. After completion of stent implantations and withdrawing the injector fromthe anterior chamber, irrigate the anterior chamber of any refluxed bloodto visualize the implanted stents.
b. Confirm proper placement of the three implanted stents, ensuring thateach stent flange is visible in the anterior chamber (shown below in Figure8). The stent’s wide flange should be visible and flush with the surfaceof the TM, and the stent’s inlet should be unobstructed. Note: minimal
blood reflux is a normal physiological response to placement of the stents,
although this does not occur in all cases.

c. Advance the injector tip towards the TM; the introducer will auto-retractand expose the insertion tube and trocar tip. Prior to targeting theimplantation site, confirm through the window that the stent is in position.
Advance the insertion tube containing the trocar towards the TM (justabove the scleral spur) and penetrate the trocar tip through the center of
the TM. The trocar is used to not only penetrate the TM, but will remain in
the tissue to act as an axial guide for the stent as the stent traverses over thetrocar through to Schlemm’s canal.
d. Gently hold the insertion tube against the TM and apply appropriatepressure to slightly indent or “dimple” the tissue (tissue should stretch justenough to form a “V” when pressing on the TM); see Figure 7.

Figure 3b. iStent infinite Injector Distal End
When properly implanted, the iStent infinite stent is intended to create a bypass
through the trabecular meshwork into Schlemm’s canal to improve aqueous
outflow through the natural physiologic pathway. The implant is provided in a

Figure 4. iStent infinite Implant Location
g. After visualization of the trabecular meshwork, the Tyvek® tray lid
containing the iStent infinite system should be opened and presented tothe user. The device should be handled in the sterile field. Caution: Do not
use the device if the Tyvek lid has been opened or if the packaging appears
damaged. In such cases, the sterility of the device may be compromised.
h. Remove the Stent Delivery Button Lock from the injector. Hold the injector
as shown in Figure 5a with your index finger comfortably on the Stent
Delivery Button and within reach of the Singulator. Hold the injector as
shown in Figure 5b with your index finger comfortably on the Stent
Delivery Button and within reach of the Singulator

Figure 9. iStent infinite rethreading of stent (left)
and flush technique (right)
Rethreading can be considered if the surgeon prematurely releases a stentprior to engaging the trocar with the trabecular meshwork.
In the event that the first injector does not deliver three stents successfully,
confirm that the number of stents implanted is less than three (3) before
utilizing a second injector. Perform the following steps:o Inspect the micro-insertion tube under the surgical microscope and verify
that at least one stent remains within the injector, or verify that at least one
stent has been retrieved from the eye.
o After successful delivery of 3 stents, do not attempt delivery of any
additional stents remaining in the second injector.

Figure 8. iStent infinite Implant Sites
5) At the end of the procedure, the following should be performed:a. Irrigate the anterior chamber with balanced salt solution (BSS) throughthe corneal wound manually, or with automated irrigation/aspiration
to remove viscoelastic and refluxed blood. Repeat as needed until all
viscoelastic has been removed.
b. Inflate the anterior chamber with saline solution as needed to achieve
physiologic pressure.
c. Hydrate the wound and ensure that the corneal incision is sealed, and place
10-0 nylon suture if needed.
d. Dispose of the injector in a sharps container.

Postoperative Retrieval of a Stent
If the surgeon determines that an instrument is required to recapture a stent after
the procedure, micro forceps of the surgeon’s choice can be used by the surgeon
as follows:
1. Prep the patient as one would for stent implantation surgery.
2. Re-open the eye at the preferred location to reach the stent. A clear corneal
incision measuring approximately 1.5 mm in length is recommended.
3. Use cohesive viscoelastic to inflate the anterior chamber to create access tothe stent’s location, move the stent away from a delicate structure if loose,
and/or protect intraocular tissues.
4. Use a gonioscope if needed to visualize the location of the stent in the anteriorchamber.
5. Insert a micro forceps device through the corneal incision and grasp thestent in a convenient and secure manner before removing the stent from theanterior chamber.
6. Irrigate the anterior chamber with balanced salt solution (BSS) through thecorneal wound to remove all viscoelastic. Press down on the posterior edge ofthe incision as needed to facilitate complete removal of viscoelastic. Repeat asneeded until all viscoelastic has been removed.
7. Inflate the anterior chamber with saline solution as needed to achieve normal
physiologic pressure.
8. Ensure that the corneal incision is sealed.
8. ADVERSE EVENT REPORTING
Adverse events and/or potentially sight-threatening complications that
may reasonably be regarded as device related must be reported to Glaukos
Corporation at:
U.S. Toll Free Phone Number: 1-800-GLAUKOS (452-8567)
Alternate Phone Number: 949-367-9600
Fax Number: 949-297-4540
9. HOW SUPPLIED
The iStent infinite System is for single use only and is supplied as follows: Threestents are preloaded within the single-use injector system, and the system
is provided sterile and non-pyrogenic in a Tyvek tray. Each stent system isindividually serialized, and the serial number is provided on the tray lid and unit
carton. The system has been sterilized by gamma radiation.
10. STORAGE REQUIREMENTS
The device should be stored at room temperature in the range of 15-30˚ C.
11. EXPIRATION DATEThe expiration date on the device package (Tyvek tray lid) is the sterility expiration
date. In addition, there is a sterility expiration date that is clearly indicated on theoutside of the unit carton. Sterility is assured if the tray seal is not punctured ordamaged before the expiration date. This device should not be used past theindicated sterility expiration date. Do not resterilize.
12. RETURN GOODS POLICY
Please contact Glaukos Corporation.
13. iSTENT INFINITE SYSTEM – PIVOTAL CLINICAL TRIAL RESULTS
A prospective, multi-center, single arm, open-label, clinical trial was conducted
at 15 sites in the U.S. (14) and the Philippines (1) to evaluate the safety andeffectiveness of the iStent infinite in glaucoma subjects where previous filteringor cilioablative procedures failed. Sixty-one subjects were implanted with theiStent infinite and 12-month data were collected. In this clinical investigation a
medication washout was not performed.
Subject Accountability
Sixty subjects (60/61 or 98.4%) completed the 12-month visit. One subject died
due to respiratory failure unrelated to treatment prior to the Month 12 visit.
Demographics and Preoperative Characteristics
The mean age of subjects was 71.7 years and there were 28 males (28/61 or
45.9%) and 33 females (33/61 or 54.1%). Thirty-seven (37/61 or 60.7%) subjects
were White, 15 (15/61 or 24.6%) were Black, 6 (6/61 or 9.8%) were Asian; race
was not reported for 3 (3/61 or 4.9%) subjects. Eleven subjects (11/61 or 18.0%)
had ethnicity reported as Hispanic or Latino. Fifty-five subjects were diagnosed
with primary open angle glaucoma (POAG), 3 subjects had pseudoexfoliative
glaucoma, and 3 subjects had pigmentary glaucoma. All 61 subjects had
undergone prior filtering or cilioablative glaucoma procedures. Preoperatively,
the mean visual field mean deviation (MD) score was -15.1 (SD 8.56) dB. Twentytwo subjects at screening had severe mean VF scores of worse than -20 dB. The
other subjects’ visual fields ranged from -20 dB to > -12 dB (n = 15) and -12 dB to
0 dB (n=24).
The mean medicated IOP at baseline was 23.5 (SD 2.8) mmHg. At baseline,
subjects were using a mean of 3.0 (± 0.9) ocular hypotensive medications, with19 (19/61 or 31.1%) on 2 or fewer medications and 42 (42/61 or 68.9%) on 3 ormore medications.
Operative Parameters and Intraoperative Ocular Adverse Events
Operative parameters are summarized in Table 1. All 61 eyes (61/61 or 100%)
were implanted with 3 stents. Overall, in the vast majority (56/61 or 91.8%) ofsurgeries, only one injector was used to implant iStent infinite. The vast majorityof subjects (91.8%; n = 56/61) reported no issues with implantation. In the 5 eyeswith implantation issues, a second injector was required (for four participants,
the second stent did not advance in the first injector, and in another participant,the third stent did not advance in the first injector, and there was also head
movement noted). There were no untoward safety findings attributed to the useof second injectors.

Postoperative Adverse Event

NumberofReports

Significant hyphema (i.e, >= 10% of anterior chamber)
Significant iris damage
Stent dislocation
Stent explant
Stent migration3
Stent obstruction4
Stent-cornea touch
Stye
Subconjunctival hemorrhage
Toxic Anterior Segment Syndrome (TASS)
Transient hypotony
Visual field loss < 2.5 dB
Visual field loss >= 2.5 dB

2
0
0
0
2
2
0
1
1
0
1
1
5

N = 61 Subjects
Number

Percent

0
0
61

0.0%
0.0%
100.0%

56
5

91.8%
8.2%

5
56

8.2%
91.8%

# of Stents Implanted
1 Stent
2 Stents
3 Stents# of Injectors Used1
2
Implantation Issues
YesNo% = 100 × (n ÷ N)

Figure 5a. Hand position on injector when pressing Stent Delivery Button

4. WARNINGS
1. The following conditions may prohibit sufficient visualization of the angle
required for safe and successful stent implantation: corneal haze, corneal
opacity, or any other conditions that may inhibit the gonioscopic view in theintended implant location.
2. The surgeon should perform a slit lamp gonioscopy examination prior to taking
a patient to surgery to exclude congenital anomalies of the angle, peripheral
anterior synechiae (PAS), rubeosis, and any other angle abnormalities that
could lead to improper placement of the stent and pose a hazard.
3. Non-clinical testing has demonstrated that the iStent infinite stents are MR
Conditional. Please see the “MRI SAFETY INFORMATION” section at the end of
this document on conditions for safe scanning.
5. PRECAUTIONS
1. The surgeon should inform the patient that the stents are MR Conditional (asnoted on their Patient ID card), and if the patient needs to undergo an MRI,
they should let their doctor know they have iStent infinite stents implanted intheir eye.
2. After the surgery, the surgeon should give the patient the Patient ID card
(enclosed in the iStent infinite packaging) with the appropriate information
filled in, and should advise the patient to keep the card in a safe place, e.g.,his or her wallet, for future reference. The surgeon should advise the patientthat this Patient ID card contains important information related to the iStent
infinite and that the card should be shown to their current and future healthcare providers.
3. The surgeon should monitor the patient postoperatively for proper
maintenance of intraocular pressure. If intraocular pressure is not adequately
maintained after surgery, the surgeon should consider an appropriate
additional therapy to reduce intraocular pressure.
4. The stent is comprised of implant grade titanium (Ti6-Al-4V ELI) with astearalkonium heparin coating. The total amount of heparin is estimated tobe less than 0.9 microgram per stent, or approximately 0.01 to 0.02 units.
5. The surgeon should be careful to avoid contact with the cornea and iris during
stent implantation in order to minimize sequelae associated with devicecornea touch, stent obstruction and/or iritis.
6. Please note that three out of 61 participants (4.9%) in the pivotal clinical trial
were phakic. Therefore, there is insufficient evidence to determine whether
the clinical performance of the device may be different in those who arephakic versus in those who are pseudophakic.

Table 1
Operative Parameters
ITT Population

No intraoperative adverse events were reported as shown in Table 2. There wereno cases in which stent implantation was attempted and 0 stents were implanted(i.e., failure to implant 3 stents).
Table 2Intraoperative Ocular Adverse Events in the Study Eye
Safety Population

Intraoperative Adverse Event
Choroidal effusion
Choroidal hemorrhage
Cyclodialysis cleft
Device malfunction identified after entry of
the injector system into the eye but prior tocontact with the target tissue
Failure to implant three stents
Flat anterior chamber requiring anteriorchamber reformation
Inadvertent perforation of the sclera
Lens trauma/IOL scratched
Lens/IOL dislocation
Loss of stent in eye
Significant capsular bag tear/rupture resulting
in vitreous loss or prolapse
Significant corneal injury
Significant hyphema (i.e., >= 10% of anteriorchamber)
Significant iris damage
Total

Number ofReports000

N = 61
Number (Percent) of
Subjects with Event
0 (0.0%)0 (0.0%)0 (0.0%)00 (0.0%)00 (0.0%)00 (0.0%)000
00 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)00 (0.0%)00 (0.0%)00 (0.0%)000 (0.0%)0 (0.0%)

Postoperative Ocular Adverse Events
There were no unanticipated adverse device effects. There were no serious ocularadverse events. There were no reports of corneal decompensation, choroidal
effusion, choroidal hemorrhage, hypotony maculopathy, deep stents (“buried”
in the trabecular meshwork) that were not visible at the last three scheduledvisits of the study, stent explantation, stent dislocation, or stent repositioning.
Approximately half of the study eyes (30/61 or 49.2%) had no reports of AEs.
A list of AEs reported and the associated rates are provided in Table 3
Table 3
Postoperative Ocular Adverse Events in the Study Eye(Sorted Alphabetically) Safety Population

Postoperative Adverse Event

A significant increase in crystalline lens opacity frombaseline defined as a change of ARLNS grade of threehalf-step increments of 0.5 per increment or greater for
nuclear opalescence, cortical or posterior subcapsular
opacities (as applicable to phakic eyes)
Age-related macular degeneration
Allergic reaction
An increase of three half-step increments of 0.5
per increment or greater in anterior subcapsular
opacities or a clinically significant cataract eligible forphacoemulsification with BCVA loss (ETDRS) of greaterthan 10 letters from baseline (as applicable to phakic
eyes)
Aqueous misdirection
Atrophy/phthisis
Blepharitis
Choroidal effusion
Choroidal hemorrhage
Chronic pain in the study eye present greater than 3months postoperative
Clinically significant cystoid macular edema
Conjunctival erosion due to tube shunt
Conjunctivitis
Corneal abrasion
Deep stents (“buried” in the trabecular meshwork) thatare not visible at the last three scheduled visits of the
study
Disc hemorrhage
Elevated IOP§
Endophthalmitis
Flat or shallow anterior chamber (e.g., shallowing of theanterior chamber that causes any amount of iris-cornea
touch)
Hyperemia
Hypotony (IOP < 6 mmHg) associated with clinicallysignificant findings
IOP increase >= 10 mmHg vs. baseline IOP§
at Day 0 to Day 1
at > Week 1 to < Month 1
at >= Month 1
IOP increase requiring oral medication§at > Day 1 to <= Week 1
at >= Month 1
IOP increase requiring surgical intervention§,1
at > Week 1 to < Month 1
at >= Month 1
Increase in C/D ratio of > 0.3 units on ophthalmoscopic
examination
Intraocular inflammation arising after the protocol's
specified medication regimen is complete
Intraocular inflammation following tube shunt surgery
Iridodialysis
Lens/IOL dislocation
Loss of best spectacle corrected visual acuity (BSCVA) of
2 lines or more2<= 30 days
> 30 days
Loss of eye
Macular edema
Ocular hypotensive medication intolerance
Ocular pain
Ocular surface disease
Perioperative inflammation
Posterior vitreous detachment
Proliferative vitreoretinopathy
PtosisPupillary block
Retinal detachment
Retinal dialysis
Retinal flap tears
Significant corneal complications including
opacification and decompensation
Significant corneal edema
Significant corneal injury
Significant damage to trabecular meshwork

NumberofReports0

N = 61
Number(Percent) of
Subjects withEvent
0 (0.0%)000

0 (0.0%)0 (0.0%)0 (0.0%)

0
0
3
0
0
0

0 (0.0%)0 (0.0%)3 (4.9%)0 (0.0%)0 (0.0%)0 (0.0%)

0
1
1
0
0

0 (0.0%)1 (1.6%)
1 (1.6%)0 (0.0%)0 (0.0%)11
00

1 (1.6%)
1 (1.6%)0 (0.0%)0 (0.0%)2
12 (3.3%)
1 (1.6%)60

5 (8.2%)3 (4.9%)1 (1.6%)2 (3.3%)2 (3.3%)
1 (1.6%)
1 (1.6%)3 (4.9%)1 (1.6%)2 (3.3%)0 (0.0%)1

1 (1.6%)200
72 (3.3%)0 (0.0%)0 (0.0%)7 (11.5%)

3
1
2
2
1
1
3
1
2

Vitreous hemorrhage
00 (0.0%)Total
64
31 (50.8%)§
A total of 8 eyes (8/61 or 13.1%) experienced 12 AEs of increased IOP (consisting of elevated
IOP, IOP increase >= 10 mmHg vs. baseline IOP, IOP increase requiring oral medication and
IOP increase requiring surgical intervention). The 4 eyes with more than one AE of increased
IOP are as follows:• One eye had an AE of IOP increase >= 10 mmHg vs. baseline IOP and an AE of IOP
increase requiring secondary surgical intervention• One eye had an AE of IOP increase requiring oral medication and an AE of IOP increase
requiring secondary surgical intervention• One eye had an AE of elevated IOP and an AE of IOP increase requiring secondary
surgical intervention• One eye had 2 AES of IOP increase >= 10 mmHg vs. baseline IOP
1. The 3 events of IOP increase requiring surgical intervention are included below in Table
4.
2. Five AEs of BSCVA loss of 2 lines or more were ongoing at Month 12
3. One subject was reported with 2 events of stent migration. The PI acknowledgedthat the visualization was impaired during implantation of the 1:00 and 4:30 stents
due to corneal arcus, striae and external location-marking dye. The stent reported as
implanted at 1:00 was identified in the 1:00 position via UBM (“imbedded deep beyond
iris insertion”), and the stent reported as implanted at 4:30 was identified in the 7:30
position via both gonioscopy and UBM.
4. The 2 AEs of stent obstruction involved complete obstruction of 2 stents each. The
investigators reported associated findings of significant hyphema in 1 case and preexisting and postoperative focal goniosynechiae in both cases. One case of stentobstruction resolved following treatment with pilocarpine, and 1 case was not treated
and was ongoing at Month 12. Both subjects experienced Month 12 MDIOP reduction
on the same medication regimen as preoperative.

The proportion of all AEs considered definitely related to study treatment by thestudy investigators was 22.2%, and consisted of AEs of elevated IOP, IOP increase≥ 10 mmHg at Day 0 to Day 1, IOP increase requiring oral medication within 1
week, loss of BSCVA of 2 lines or more occurring within 30 days, perioperative
inflammation, significant hyphema, stent migration, stent obstruction,
subconjunctival hemorrhage and transient hypotony. Please note that the one
device-related AE of early, transient BSCVA loss of 2 lines was reported for a
subject in whom the BSCVA loss occurred following an AE of significant hyphema;
this BSCVA loss was transient and fully resolved after the AE of hyphema had
resolved.
Secondary Surgical Interventions
Secondary surgeries over the course of the 12-month follow-up are shown in
Table 4. Tube shunt surgery was reported for 3 eyes (3/61 or 4.9%). None of theAEs requiring SSIs were device-related.
Table 4
Secondary Surgical Interventions in the Study Eye
Safety Population
Secondary Surgical Intervention
Overall
Tube shunt

0
2
3
1
7
4
1
0
0
0
0
0
0
0

1 (1.6%)6 (9.8%)0 (0.0%)2 (3.3%)3 (4.9%)1 (1.6%)
7 (11.5%)
4 (6.6%)
1 (1.6%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)000

0 (0.0%)0 (0.0%)0 (0.0%)N = 61n (%)
3 Reports from 3 Subjects
31 (4.9%)

The counts (n) are the number of subjects reported with the corresponding events. % = 100
× (n ÷ N).
All SSIs, regardless of reason, were included.
1. One subject reported with Month 12 MDIOP higher than baseline MDIOP and underwent
tube shunt surgery 1 week after the Month 12 exam.

Effectiveness Results
The iStent infinite is effective in reducing intraocular pressure in this glaucoma
study population. Tables 5 and 6 provide an overview of the primary effectivenessanalyses based on 12-month diurnal IOP data.
Table 5
Analyses of Responder Effectiveness Endpoint
Proportion of Responders at Month 12
Analysis Population/Imputation Method for Missing Data
ITT Population/Worst Postoperative IOP & Last Available
Medication Classes1
ITT Population/Failure Assumption3
PP Population
ITT Population/Exclusion from Cohort4
ITT Population/Multiple Imputation5n/N (%)(95% CI)
N= 61
44/61 (72.1%)(59.2%, 82.9%)2
44/61 (72.1%)(59.2%, 82.9%)2
43/59 (72.9%)(59.7%, 83.6%)2
44/60 (73.3%)(60.3%, 83.9%)2
73.4%⁵(62.2%, 84.6%)⁶

Subjects with ≥ 20% reduction in MDIOP at Month 12 vs. Baseline on the same or fewer ocularhypotensive medication classes as Baseline were responders.
Subjects with (i.) hypotony (IOP < 6 mmHg) associated with clinically significant findings, (ii.)
loss of light perception, (iii.) IOP-related SSIs, (iv.) cyclodialysis cleft, and/or (v.) no stents visible
were treated as non-responders.
1. Responder status for the 1 subject with missing data at Month 12 was determined using theworst postoperative IOP and the last available number of medication classes.
2. Exact confidence limits using the Clopper-Pearson method.
3. The 1 subject who missed the 12-month evaluation was considered a non-responder.
4. The 1 subject who missed the 12-month evaluation was excluded from the total cohort.
5. Multiple imputation was used for the 1 subject with missing data at Month 12.
6. Based on the normal approximation to the binomial distribution.

Table 6
Analyses of IOP Change from Baseline Effectiveness Endpoint
12-Month Diurnal IOP Change from Baseline
Analysis Population/Imputation Method for Missing Data
ITT Population/Worst Postoperative IOP2

1
6

N = 61
Number(Percent) of
Subjects withEvent
2 (3.3%)0 (0.0%)0 (0.0%)0 (0.0%)1 (1.6%)2 (3.3%)0 (0.0%)1 (1.6%)
1 (1.6%)0 (0.0%)1 (1.6%)
1 (1.6%)4 (6.6%)

PP Population

ITT Population/Exclusion from Cohort3

ITT Population/Multiple Imputation⁴

N
Mean ± SD(95% CI)1
61-5.5 ± 5.24(-6.9, -4.2)
59-5.5 ± 5.29(-6.9, -4.1)
60-5.6 ± 5.27(-6.9, -4.2)
61-5.5 ± 0.67⁵(-6.9, -4.2)

The following imputation methods were used for the 12-month MDIOP:
i. For subjects with hypotony associated with clinically significant findings, cyclodialysis
cleft, and/or no stents visible, the worst postoperative IOP on the same or greater numberof OHT medication classes as Baseline was used. Note: if a subject was on fewer OHT
medication classes than Baseline, then the Baseline IOP was used.
ii. For subjects with loss of light perception, the observed 12-month MDIOP was used.
iii. For subjects with IOP-related SSIs, the worst postoperative IOP prior to SSI on the sameor greater number of OHT medication classes as Baseline was used. Note: if a subject was on
fewer OHT medication classes than Baseline, then the Baseline IOP was used.
iv. For subjects on more OHT medication classes than at Baseline, the worst postoperative
IOP on the same or greater number of OHT medication classes as Baseline was used.
1. Based on the t-distribution.
2. The worst postoperative IOP was used as the 12-month MDIOP for the 1 subject who
missed the 12-month evaluation.
3. The 1 subject who missed the 12-month evaluation was excluded from the total cohort.
4. Multiple imputation was used for the 1 subject with missing data at Month 12.
5. Mean ± SE for this value.

Effectiveness stratified by age, sex, race, and ethnicity, as well as baseline IOP and
glaucoma type is provided in Figure 10.
Figure 10
Forest Plot of Responder Effectiveness Endpoint
Proportion of Subjects with MDIOP Reduction ≥ 20% from Baseline at
12 Months on the Same or Fewer Medication Classes by Demographic/
Preoperative Characteristics
ITT Population

Vertical line denotes overall responder rate.
Horizontal lines with vertical bars correspond to 95% CIs.
Failed one or more incisional glaucoma surgeries or cilioablative procedures.
1 Glaucoma secondary to elevated episcleral venous pressure.

Additional detail regarding the reasons patients did not achieve the responder
endpoint is shown in Table 7. Although more than one reason could result ina subject being a non-responder, the hierarchy used was as follows: 1) MDIOP
reduction < 20% at Month 12 vs. Baseline, 2) on more medication classes at Month
12 vs. Baseline, 3) SSIs before Month 12 and 4) missed Month 12 MDIOP data.
Table 7
Non-Responder Categories at Month 12
ITT Population
N = 61n (%)
17 (27.9%)

Total Non-Responders
Non-responders due to MDIOP reduction < 20% or on more
medication classes at Month 12 vs. Baseline
MDIOP reduction < 20% at Month 12 vs. Baseline
On more OHT medication classes at Month 12 vs. Baseline
Non-responders for reasons other than < 20% MDIOP reduction or
on more OHT medication classes at Month 12 vs. Baseline1
Secondary Surgical Intervention affecting IOP
Loss of light perception
Hypotony associated with clinically significant findings
Cyclodialysis cleft
No stents visible
Missing 12-month diurnal IOP data2
Withdrew Consent
Investigator Decision
Lost to Follow-up
Death
Adverse EventOther

14 (23.0%)
12 (19.7%)
2 (3.3%)3 (4.9%)2 (3.3%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)1 (1.6%)0 (0.0%)0 (0.0%)0 (0.0%)1 (1.6%)0 (0.0%)0 (0.0%)n = number of eyes with the corresponding responses. % = 100 × (n ÷ N).
1. Subjects were included in the primary category of “Non-responders for reasons other than
MDIOP reduction < 20% or on more medication classes at Month 12 vs. Baseline.”
2. The outcome of this 1 subject was imputed for the 12-month analyses.

Summary of Supplemental Clinical Information
A. The vast majority of subjects (55/60 or 91.7%) with Month 12 data reduced(n = 26) or maintained (n = 29) their medication burden and only 5 subjects
increased medication burden.
B. Mean Month 12 MDIOP in 57 available subjects without IOP-related SSIs orother events was 16.9 (SD 4.2) mmHg, corresponding to a mean MDIOP
reduction of 6.5 mmHg or 27.7%.
14. LABELING
Not all symbols may be included in the labeling of this product.
SymbolDefinition
Catalogue/Model
NumberSymbolSerial Number(for the stent)

Manufacturer

Lot Number

Sterilized by Gamma Irradiation

Do not reuseyyyy-mm-dd

Definition
Consult instructions For use

Use-by date(year-month-day)For prescription use only
30˚C
15˚C

Do not use if
package is damaged

Temperature Storage
Requirement
MR Conditional

15. MRI SAFETY INFORMATION
Non-clinical testing has demonstrated that the iStent infinite Trabecular MicroBypass System (Model iS3) is MR Conditional. A patient with this device can besafely scanned in an MR system meeting the following conditions:• Static magnetic field of 3 T or less
• Maximum spatial gradient magnetic field of 4,000 gauss/cm (40 T/m)
• Maximum MR system reported, whole body averaged specific absorption rate(SAR) of 4 W/kg
Under the scan conditions defined above, the iStent infinite Trabecular MicroBypass System (Model iS3) is not expected to produce a clinically significant
temperature rise after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by iStent infinite extends lessthan 15 mm from the device when imaged with a gradient echo pulse sequence
and a 3.0 T MRI system.
16. CAUTION
Federal law restricts this device to sale by, or on the order of, a physician.
Physician training by Glaukos representative is required prior to use of this device.
Training consists of three main parts:• Didactic session• Simulated implantation of iStent infinite• Supervised iStent infinite stent implantation in clinical cases until implantation
proficiency is demonstrated
Manufacturer:
Glaukos Corporation
229 Avenida Fabricante
San Clemente, CA 92672 U.S.A.
Tel: +1.949.367.9600, Fax: +1.949.367.9984
www.glaukos.com
Toll-Free: 1-800-GLAUKOS (452-8567)
Patented: Patent info: www.glaukos.com/patents
Glaukos® and iStent infinite® are registered trademarks of Glaukos Corporation.
Tyvek® is a registered trademark of DuPont USA.