iStent inject® W Trabecular Micro-Bypass System
INSTRUCTIONS FOR USE
DEVICE DESCRIPTION
Catalogue #Description

G2-W

Glaukos iStent inject® W
System Model G2-W withtwo G2-W heparin coatedTrabecular Micro-Bypass
Stents preloaded in oneinjector.

The iStent inject® W System
contains two intraocular stents
that are manufactured fromtitanium (Ti6Al4V ELI) and arecoated with stearalkonium heparin(note: the heparin is from a porcine
source). The stent has a single
piece design, is approximately
360 microns in height and 360
microns in diameter. The injector
has been designed by Glaukos
Corporation to implant two model
G2-W stents into Schlemm’s canal,
which creates a patent opening in
the trabecular meshwork and reestablishes normal physiologicaloutflow.
HOW SUPPLIED
Each iStent inject W 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 W 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 W Trabecular
Micro-Bypass System is intended
to reduce intraocular pressurein adult 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 W System iscontraindicated under the following
circumstances or conditions:•
In eyes with primary angle
closure glaucoma, or secondary
angle-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 venouspressure.
INSTRUCTIONS FOR USE
1. 
Makeacorneal
incision.
Stabilize the anterior chamber
to ensure it remains inflated.
2. 
Place a gonioscope on thecornea and reposition thesurgical microscope as needed
to visualize the trabecularmeshwork,throughthegonioprism, on the nasal side ofthe eye.
3. Enter the eye with the iStent
inject W.
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.
7. 
Look through the slot in theASinsertion tube and verify thestent is securely in place.
8. 
While remaining in the eye,relocate the tip of the injector
for implantation of the secondstent; 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. U se viscoelastic to inflate theanterior chamber to createaccess 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 securelocation.
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. I nflate the anterior chamberwith saline solution as neededto achieve normal physiologic
pressure.
10. Ensure that the corneal incision
is sealed.
WARNINGS/PRECAUTIONS• 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 enhance
the formation or progression ofcataract.
•Do not use the device 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 W is MR-Conditional;
see MRI Information below.
•Physician training by Glaukos
personnel is required prior to useof this device. Training consistsof:◦ Didactic session◦ Simulated
implantation
iStent inject Wof◦ Supervised iStent inject W
implantation of clinical cases
until implantation proficiency
is demonstrated•
Do not re-use the stent(s)orinserter,
as
this
may
resultininfection
and/orintraocularinflammation,aswell as occurrence of potential
postoperative adverse events

as shown below under “PotentialComplications.”• There are no known compatibility
issues with the iStent inject W
and other intraoperative devices(e.g., viscoelastics) or glaucomamedications.
• Unused product & packaging may
be disposed of in accordance
withfacilityprocedures.
Implanted medical devices andcontaminated products must be
disposed of as medical waste.

scanned 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
4 W/kg (First Level Controlled
Operating Mode)• The surgeon should monitor thepatient postoperatively for proper
maintenanceof
intraocularpressure. If intraocular pressure
is not adequately maintained
after surgery, the surgeon
should consider an appropriate
treatment regimen to reduce
intraocular pressure.

Under
thescanconditions
defined above, the iStent inject
W Trabecular Micro-Bypass Stent(Model G2-W 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:• Choroidalcomplication(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

Static magnetic field of 7-Tesla,
ONLY:
Non-clinical testing demonstrated
that the iStent inject W Trabecular
Micro-Bypass Stent (Model G2-W)
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) of4-W/kg for 15 minutes ofscanning(i.e.,perpulsesequence)• First Level Controlled Operating
Mode of operation for the MRsystem•Use of a transmit/receive RF
head coil, ONLY

Potential postoperative events are
as follows:•Cataract
formation
and/orprogression in phakic patients
may occur• Choroidal complication (massiveMRI-Related Heating
hemorrhage or effusion)
In non-clinical testing, the device• Chronic hypotony
produced a temperature rise of• Clinicallysignificant
cystoid
0.4°C during MRI performed formacular edema
15-minutes of scanning (i.e., per• Endophthalmitispulse sequence) in a 7-Tesla/298• Flat anterior chamber
MHz MR system (Philips Acheiva,• Significant loss of best corrected
Philips Healthcare, Cleveland, OH)visual acuity (BCVA)
using at transmit/receive RF headcoil.
• Intraocular inflammation (nonpreexisting)• IOL dislocation (in pseudophakicLABELINGeyes)
Thefollowing symbolsDescriptionare used onSymbol•
IOP
increaserequiringthe device packaging.
Catalogue/Model
management
with
oralorSymbolDefinition
SymbolDescription
Numberintravenous medications or with
SymbolDescription
Catalogue/Model
Catalogue/Model
SerialNumbersurgical intervention
NumberCatalogue/Model
REF
Number(forthestent)
REF
Number• Pupillary block
SymbolDescription
SerialNumberSerialNumberSerialNumberSN(forthestent)
SymbolDescription•Retinal complications (dialysis,(forthe stent)
NumberSN
Catalogue/Model(forLotthe stent)
REF
Numberflap tears, detachment, orLot Number
LOT
Lot Number
LOT
SerialNumberCatalogue/Model
proliferative vitreoretinopathy)
Lot
NumberDo
not re-use
SN(forthe re-usestent)
Do not•
Secondary surgicalintervention
NumberDo not re-use
LotnotNumberDo
re-useLOT
including, but not limited to, theYYYY-MM-DD
YYYY-MM-DD
By (year-month-day)
UseUseBy (year-month-day)
SerialNumberYYYY-MM-DD
Use
By (year-month-day)following:
Do not re-use
DonotusepackageUse DoBy (year-month-day)yyyy-mm-dd
notifif use
if package◦ Trabeculectomy(for the stent)
Dodamaged
not usepackage
isisdamaged
isdamagedYYYY-MM-DDUse
By(year-month-day)Donotuseifpackage◦ IOL repositioning or removal
Sterilized by Gamma
isSterilized
damagedby Gamma
Irradiation
Sterilized by Gamma
Lot NumberDo
not use if package◦ Stent repositioningor removal
Irradiation
Storage
Irradiation
isTemperaturedamagedSterilized
by Gamma
Temperature
Storage
Requirements• Significant corneal complications
Irradiation
Sterilized
by Gamma Storage
Temperature
Requirements
including edema,Doopacification,
Irradiation
CE Marking
not re-use
Requirements
CE Marking Storage
decompensation
TemperatureTemperature
Storage
Requirements
Requirements
MRCE
Conditional
Marking• Significant
damagetotheMR Conditional
CE Marking
trabecularmeshwork
YYYY-MM-DD
Use By (year-month-day)Rx Only
For prescription use onlyMR
Rx OnlyMR
Conditional
ForConditionalprescription
use only• Significant hyphema

REF
SN

LOTg
DH

REF
SN

LOTIK

• Significant iris damage
Do not use if package
Rx
Rx Only
Onlydamaged• Significant loss ofisbest
corrected
visual acuity (BCVA)
Sterilized by Gamma EC REP• Stent dislocation or malposition
EC REP
Irradiation• Stent obstruction

M

Temperature Storage EC REP
STORAGE REQUIREMENTS
The device shouldRequirements
be stored at
EC REP
room temperature (15-30°C).
CE Marking

MRI SAFETY INFORMATIONMR Conditional

MR Conditional
Consult Instructions For
Consult Instructions For
Use.
Use.
For
prescription
use only
For prescription
For prescription
use
only use only
Manufacturer
Manufacturer
Consult Instructions For
ConsultInstructions
For
Consult
Instructions
For
Authorized
European
Use.
Use
Authorized
Representative
Use. European
Representative
Manufacturer
Manufacturer
Manufacturer

Authorized European
Representative

Authorized European
RepresentativeManufacturer
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

Static magnetic field of 3-Tesla

less:
Rxor Only

For prescription use only

Non-clinicaltesting
hasGlaukos® and iStent inject® W are registeredtrademarks of Glaukos Corporation.
demonstrated that
the Instructions
iStentConsultFor
inject W (Model G2-W) is MRTyvek® is a registered trademark of DuPont
Use.
USA.
Conditional.
A patient with thisManufacturer
device can bePart No. 45-0201 Rev 35/21