PATIENT INFORMATION LEAFLET
iStent infinite® Trabecular Micro-Bypass System,
Model iS3

Device description
This document has been provided to assist in yourunderstanding of the iStent infinite® Trabecular MicroBypass System (referred to after this as iStent
infinite), which is one option for managing yourglaucoma. Please read the entire brochure and discuss
the benefits and risks with your eye care provider.
Prior to undergoing any type of surgery, it is important
to make sure your questions and concerns are fullyaddressed.
Intended Purpose of the iStent infinite
The iStent infinite Trabecular Micro-Bypass System
Model iS3 is intended to reduce intraocular pressurein adult patients diagnosed with primary open-angle
glaucoma (POAG) currently treated with ocularhypotensive medication. The device can be implantedwith or without cataract surgery. Three identical stentdevices are implanted in the eye to help reduce youreye pressure.

Figure 1 – iStent infinite compared to a penny
When implanted in the eye in the iStent infinite canhelp lower your eye pressure by providing a channel forthe eye fluid to move out of the front chamber of theeye. Less fluid in the chamber means lower pressure.
Figure 2 shows what the iStent infinite looks like once
it is implanted in the eye.

Expected Lifetime of the device
The iStent infinite is designed to last throughout yourlifetime.
Is the iStent infinite right for me?
You have been diagnosed with glaucoma which is adisease that damages the optic nerve in the back of
the eye and can cause vision loss. There are different
kinds of glaucoma. The most common type is called
primary open angle glaucoma. The iStent infinite may
be a good option if you have this kind of glaucoma
and/or if you are planning to have surgery to remove
your cataract.
A cataract is a clouding of the lens in the eye thataffects vision. If you have cataract surgery along with
the iStent infinite as part of a single procedure, 3
stents are implanted in your eye immediately after
your cataract is removed and an IOL is implanted.
Your eye surgeon will use the same surgical incisionthat was used to remove your cataract to insert theiStent infinite.
iStent infinite
The iStent infinite contains 3 tiny metal devices
designed to stay in place inside the eye and create adrainage channel to increase the flow of fluid. Figure
1 below shows how tiny the stents are by comparing
those to a U.S. penny. The stents are made of implant
grade titanium and coated with a very thin layer ofheparin coating. The total amount of heparin is very
minute, i.e. estimated to be less than 0.9 microgram
per stent, or approximately 0.01 to 0.02 units.
These 3 stents are preloaded into a custom injector,
which is the instrument your surgeon uses to implant
the stents in your eye. During implant surgery, the 3stents will be placed closely together to help reduce eyepressure.

Figure 2 – iStent infinite implanted in the eye
Before Surgery
Before surgery your doctor will examine your eye, takemeasurements of your eye and eye pressure, anddetermine which type of intraocular lens (IOL) is bestfor you (if applicable). Depending on which
medications you are taking, you may be asked to stoptaking them a few days before surgery or you may beasked to start new medications. Your doctor may haveadditional recommendations for you. Before surgery
make sure you ask questions about anything you
don’t understand.
Surgery Day
On the day of surgery, you will be given eye drops
and possibly medicine to help you feel more relaxed.
You will also be given drugs to numb the eye so thatyou do not feel pain during the procedure. Yoursurgeon will perform the procedure using a
microscope that shows a magnified view of your eye.
Your surgeon will make a small incision in the outersurface of the eye. If you are also having cataract
surgery, the cataract will be removed, and an IOL will
be implanted into the capsule to replace your naturallens. Once implanted, the IOL performs just like yournatural lens to restore clear vision. Immediately after
the cataract portion of the surgery is completed, yoursurgeon will use the same incision to enter the eyewith the iStent infinite injector instrument and the 3stents will be implanted.
After the procedure, your eye surgeon will usuallyplace a shield over your eye after surgery to protect
your eye. You will spend a short time in the outpatient
recovery area and afterwards you will be able to gohome to recover. You will not be allowed to drive home.

PATIENT INFORMATION LEAFLET
iStent infinite® Trabecular Micro-Bypass System,
Model iS3

so you will need to plan to have someone drive you
home. Your eye surgeon will provide you with specificinstructions after surgery.
After Surgery
You will be given eye drops to help your eye heal andprevent infection and your doctor will give you specificinstructions for when to use your eye drops. Your eye
doctor will examine you after surgery (usually the dayafter surgery) and check your eye pressure, which may
change during the first several days after surgery. Besure to talk with your doctor to make sure you
understand the recovery process and postoperative
instructions.
Your eye doctor should give you a Patient Identification
card that contains important information about youriStent infinite. Please keep this card in a safe placee.g., your wallet or purse, for future reference.
The implant card contains important information
related to the iStent infinite and that the card should
be shown to your current and future health careproviders. The implant card also identifies the iStent
infinite stent as “MR Conditional” (MagneticResonance). If you need to undergo an MRI (Magnetic
Resonance Imaging is a noninvasive test that uses
magnets), you should let your doctor know that you
have an iStent infinite stent implanted in your eye, andshow the doctor your implant card and show it to yourcurrent and future healthcare providers.
Potential Undesirable Side Effects
The following side effects could possibly result fromuse of this product:•Significant Blood in front of the eye(hyphema)•
Significant iris damage•
Significant loss of best corrected visualacuity (BCVA)•
Stent dislocation or malposition•
Stent obstruction•
Cataract formation or progression in eyesthat have the natural lens intact.
Residual Risks
Medications or second surgeries may be needed toaddress the potential side effects listed above. Further,
due to the progressive nature of glaucoma regardlessof treatment with this product, you may need
medications or second surgeries, even after you havebeen treated with this product.
Symptoms that could indicate that the device ismalfunctioning
If you experience any unusual symptoms, e.g. eye
pain, vision loss, contact your eye doctor.
Precautions and preventative measures
Regular appointments with your eye doctor are
recommended so that they can make sure your eye
pressure is controlled. If needed, your doctor will
recommend additional therapy, including appropriate
medication or other treatment, to control your eye
pressure.
.

Discuss an appropriate follow-up schedule with youreye doctor based upon your medical history.
Any serious incident that occurs in relation to thestent device should be reported to the manufacturer
using email medicalsafety@glaukos.com and to theTherapeutic Goods Administration. The address ofthe Therapeutic Goods Administration’s website is:https://www.tga.gov.au/
MRI INFORMATION

Static magnetic field of 3-Tesla or less:Non-clinical testing has demonstrated that the iStentinfinite Trabecular Micro-Bypass Stent, Model iS3 is
MR Conditional.
A patient with this device can be safely scanned in
an MR system meeting the following conditions:• Static magnetic field: 3T 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 (First Level Controlled OperatingMode)
Under the scan conditions defined above, the iStent
infinite Trabecular Micro-Bypass Stent, 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
the device extends less than 15 mm from the device
when imaged with a gradient echo pulse sequenceand a 3T MRI system.
Static magnetic field of 7-Tesla, ONLY:
Non-clinical testing demonstrated that the iStent
infinite Trabecular Micro-Bypass Stent, Model iS3 isMR Conditional.
A patient with this device can be safely scanned
immediately after implantation in an MR systemmeeting the following conditions:• Static magnetic field of 7T, ONLY
• Maximum spatial gradient magnetic field of
10,000-gauss/cm (extrapolated) or less
• Maximum MR system reported, whole body
averaged specific absorption rate (SAR) of
4-W/kg for 15 minutes of scanning (i.e., perpulse sequence)• First Level Controlled Operating Mode ofoperation for the MR system• Use of a transmit/receive RF head coil, ONLY
MRI-Related Heating
In non-clinical testing, the device produced atemperature rise of 0.4°C during MRI performed for
15-minutes of scanning (i.e., per pulse sequence) in a
7-Tesla/298-MHz MR system (Philips Acheiva, Philips

PATIENT INFORMATION LEAFLET
iStent infinite® Trabecular Micro-Bypass System,
Model iS3

Healthcare, Cleveland, OH) using at transmit/receive
RF head coil.
MR system reported, whole body averaged: SAR < 1W/kg.
Artifact Information
In non-clinical testing, the image artifact caused by
the device extends approximately 23-mm from thisdevice when imaged using a gradient echo pulse
sequence and a 7T MR system.
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
Australian Sponsor
RQSolutions Ltd.
44 Del Monte Pl.
Copacabana NSW 2251
Australia
Glaukos® and iStent infinite®
trademark of Glaukos Corporation.

isaregisteredP-000131 Rev 103/24.