ASISTENT INJECT® TRABECULAR MICRO-BYPASS SYSTEM
INSTRUCTIONS FOR USE
DEVICE DESCRIPTION
Catalogue #Description

G2-M-IS-AS

Glaukos iStent inject
System Model G2-M-ISAS, with two (2) heparincoated Trabecular MicroBypass Stents (ModelGTS400) preloaded inone injector

The iStent inject® System contains
two intraocular stents that aremanufactured
fromtitanium(Ti6Al4V ELI) and are coated withstearalkonium heparin (note: theheparin is from a porcine source).
The stent has a single piece design,
is approximately 360 microns
in height and 230 microns indiameter.
The injector has been
designed by Glaukos Corporation
to implant two model GTS400
stents into Schlemm’s canal,
which creates a patent opening in
the trabecular meshwork and reestablishes normal physiologicaloutflow.
HOW SUPPLIED
Each iStent inject System isprovided sterile in a blister tray
(only the inner contents of theblister tray are sterile). Two stents
are already assembled onto thesingle-use injector.
The blistertray lid is labeled with the required
product identification information.
Each stent within the injector
system is serialized and a lot
number for the injector is clearly
indicated on the labeling.
TheiStent inject System is sterilized
by gamma irradiation.
The expiration date on the device
package (tray lid) is the sterility
expiration date. In addition, there
is a sterility expiration date thatis clearly indicated on the outsideof the unit carton.
Sterility isassured if the tray seal is notbroken, punctured or damaged
until the expiration date.
Thisdevice should not be used past theindicated sterility expiration date.
INDICATIONS FOR USE
The iStent inject Trabecular MicroBypass System
is intended toreduce intraocular pressure inadult patients diagnosed withmild to moderate primary openangle glaucoma (POAG) currently
treated with ocular hypotensive
medication. The device can be
implanted with or without cataract
surgery.
CONTRAINDICATIONS
The iStent inject System iscontraindicated under the following
circumstances or conditions:7) Look through the slot in theinsertion tube and verify thestent is securely in place.
8) While remaining in the eye,relocate the tip of the injector
for implantation of the second
stent; repeat steps 5 through 7.
9) Remove the injector from theeye.
10) Irrigatetheanteriorchamber with balanced salt
solution (BSS) through thecorneal wound to remove
all viscoelastic. Press downon the posterior edge ofthe incision as needed tofacilitate complete removal ofviscoelastic.
11) Inflate the anterior chamberwith saline solution as neededto achieve normal physiologic
pressure.
12) Ensure that the corneal incision
is sealed.
Retrieval of an Implanted Stent
1. Prep the patient as one would
for stent implantation surgery.
2. Re-open the eye at thepreferred location in order toreach the stent. Ideally, use aclear corneal incision measuring
approximately 1.5mm in length.
3. Use viscoelastic to inflate theanterior chamber to create
access to the stent’s location,
move the stent away from adelicate structure if loose, and/or protect intraocular tissues.
4. Use a gonioscope if needed tovisualize the location of thestent in the anterior chamber.
5. Insert a micro forceps device
through the corneal incision
6. Open the jaws by pressing thetrigger button and grasp thestent. The stent can be grasped
in any convenient and secure
location.
7. Remove the stent in the jawsof the micro forceps device
from the eye taking care not tocontact the iris, cornea, or lens,if possible
8. Irrigate the anterior chamberwith balanced salt solution (BSS)
through the corneal wound to
remove all viscoelastic. Press
down on the posterior edgeof the incision as needed tofacilitate complete removal ofviscoelastic.
9. Inflate the anterior chamberwith saline solution as neededto achieve normal physiologic
pressure.
10. Ensure that the corneal incision
is sealed.
WARNINGS/PRECAUTIONS• In eyes with primary angle
closure glaucoma, or secondaryangle-closure
glaucoma,including neovascular glaucoma,
because the device would not
be expected to work in suchsituations• In patients with retrobulbar
tumor, thyroid eye disease,
Sturge-Weber Syndrome or any
other type of condition that may
cause elevated episcleral venous
pressure
INSTRUCTIONS FOR USE
1) Makeacornealincision.
Stabilize the anterior chamber
to ensure it remains inflated.
2) Place a gonioscope on thecornea and reposition thesurgical microscope as neededto visualize the trabecularmeshwork,throughthegonioprism, on the nasal side ofthe eye.
3) Enter the eye with the iStentinject.
4) Slide the retraction (back)button to draw back theinsertion sleeve and expose theinsertion tube and trocar.
5) Advance the trocar tip tothe center of the trabecularmeshwork.
6) Press the trigger (front) button
to inject the stent through thetrabecular meshwork and into
Schlemm’s Canal.

• For prescription use only.
• This device has not been studiedin patients with uveitic glaucoma.
• Patients should be informed thatplacement of the stents, without
concomitant cataract surgery inphakic patients, can enhancethe formation or progression ofcataract.
• Do not use the devices if theTyvek® lid has been opened or
the packaging appears damaged.
In such cases, the sterility of thedevice may be compromised.
• Due to the sharpness of certain
injector components (i.e. theinsertion sleeve and trocar), careshould be exercised to grasp theinjector body. Dispose of device
in a sharps container.
• iStent inject is MR-Conditional;
see MRI Information below.
• Physician training by Glaukos
personnel is required prior to useof this device. Training consists of:◦ Didactic session◦ Simulated
implantation
iStent injectof◦ Supervised
iStentinjectimplantation of clinical cases
until implantation proficiency
is demonstrated• Do not re-use the stent(s)orinserter,asthismay
resultininfection
and/orintraocularinflammation,aswell as occurrence of potential

postoperative adverse eventsas shown below under “PotentialComplications.”• There are no known compatibility
issues with the iStent inject andotherintraoperative
devices(e.g., viscoelastics) or glaucoma
medications.
• Unused product & packaging may
be disposed of in accordance
withfacilityprocedures.
Implanted medical devices andcontaminated products must be
disposed of as medical waste.

A patient with this device can bescanned safely immediately after
implantation in an MR systemmeeting the following conditions:• Static magnetic field: 3-Teslaor less
• Maximum spatial magnetic fieldof 4,000 gauss/cm (40 T/m)
(extrapolated)• Maximum MR system reported,
whole body averaged specificabsorption rate (SAR) of 4W/kg (First Level Controlled
Operating Mode)• The surgeon should monitor thepatient postoperatively for proper
maintenanceofintraocularpressure. If intraocular pressure
is not adequately maintained
after surgery, the surgeon
should consider an appropriate
treatment regimen to reduce
intraocular pressure.

Under the scan conditions defined
above, the iStent inject Trabecular
Micro-Bypass
Stent(ModelG2-M-IS) is not expected toproduce a clinically significant
temperature rise after 15 minutesof continuous scanning (i.e., perpulse sequence).

POTENTIAL COMPLICATIONSIntraoperative or postoperative
adverse events may be devicerelated or non-device related.

In non-clinical testing, the image
artifact caused by the device
extends less than 15 mm fromthe device when imaged using a
gradient echo pulse sequence anda 3-Tesla MR system.

Potential intraoperative events are
as follows:• Choroidal
complication(hemorrhage or effusion)• Crystalline lens touched byinjector• Posterior capsular bag rupture,
in case of combined cataract
surgery• Prolonged
anterior
chambercollapse• Significant corneal injury• Significant damage to trabecularmeshwork• Significant hyphema• Significant iris damage• Vitreous loss or vitrectomy,
in case of combined cataract
surgery• Stent malposition or loose stentinside eye requiring reacquisition
Potential postoperative events are
as follows:• Cataractformation
and/orprogression in phakic patients
may occur• Choroidal complication (massivehemorrhage or effusion)• Chronic hypotony• Clinicallysignificant
cystoid
macular edema• Endophthalmitis• Flat anterior chamber• Significant loss of best correctedvisual acuity (BCVA)• Intraocular inflammation (nonpreexisting)• IOL dislocation (in pseudophakiceyes)• IOPincrease
requiring
management
withoralorintravenous medications or withsurgical intervention• Pupillary block• Retinal complications (dialysis,flap tears, detachment, orproliferative vitreoretinopathy)• Secondary surgical intervention
including, but not limited to, thefollowing :◦ Trabeculectomy◦ IOL repositioning or removal◦ Stent repositioning or removal• Significant corneal complications
including edema, opacification,
decompensation• Significant
damagetothetrabecular meshwork• Significant hyphema• Significant iris damage• Significant loss of best correctedvisual acuity (BCVA)• Stent dislocation or malposition• Stent obstruction
STORAGE REQUIREMENTS
The device should be stored atroom temperature (15-30°C)
MRI SAFETY INFORMATION

Static magnetic field of 3-Teslaor less:
Non-clinicaltestinghas
demonstrated that the iStentinject (Model G2-M-IS) is MRConditional.

Static magnetic field of 7-Tesla,
ONLY:
Non-clinical testing demonstrated
that the iStent inject Trabecular
Micro-Bypass Stent (ModelG2M-IS) is MR Conditional.
A patient with this device can besafely scanned immediately after
implantation in an MR systemmeeting the following conditions:• Static magnetic field of 7-Tesla,
ONLY• Maximum
spatialgradientmagnetic field of 10,000-gauss/
cm (extrapolated) or less
• Maximum MR system reported,
whole body averaged specificabsorption rate (SAR) of 4-W/
kg for 15 minutes of scanning(i.e., per pulse sequence)• First Level Controlled Operating
Mode of operation for the MRsystem• Use of a transmit/receive RF
head coil, ONLY
MRI-Related Heating
In non-clinical testing, the device
produced a temperature rise of0.4°C during MRI performed for
15-minutes of scanning (i.e., perpulse sequence) in a 7-Tesla/298MHz MR system (Philips Acheiva,Philips Healthcare, Cleveland, OH)
using at transmit/receive RF headcoil.
LABELING
The following symbols are used on
the device packaging.
SymbolDefinition
Catalogue/Model
NumberSerial Number(for the stent)

gLot Number

Do not re-use

Use By (year-month-day)

Sterilized by Gamma
Irradiation
Temperature
Storage Requirements

MR Conditional

For prescription use only
Consult Instructions For
UseM

Manufacturer’sCompany Address
Do not use if package
is damaged

M Manufacturer

Glaukos Corporation229 Avenida Fabricante
San Clemente, CA 92672 USA
Tel: 949.367.9600, Fax: 949.367.9984
www.glaukos.com

Glaukos® and iStent inject® are registeredtrademarks of Glaukos Corporation.
Tyvek® is a registered trademark ofDuPont USA.
Part No. 45-0119 rev 404/21