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iStent inject® W

iStent inject® W is intended to reduce intraocular pressure safely and effectively in patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma, or pigmentary glaucoma. And it’s precision-engineered to optimise stent visualisation and placement, enhance procedural predictability, and increase confidence.

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Two iStent inject® W devices that use trabecular micro-bypass technology.
Two iStent inject® W devices that use trabecular micro-bypass technology.

Key Advantages to Using the Device Include:

Minimal Invasiveness

Implanted through a single-entry point, iStent inject® W is implanted during cataract surgery or as a stand-alone procedure. If implanted during cataract surgery, iStent inject® W is implanted through the incision needed for cataract surgery itself.

Designed to Improve Physiological Outflow

iStent inject® W is designed to create a bypass through the primary blockage site (trabecular meshwork).

Positive Patient Outcomes

In clinical studies, most patients experience a reduction in IOP and a reduction in reliance on glaucoma medication1-3.

Rapid Recovery Time

Patient recovery time is usually rapid, which allows a quick return to normal activities.

Safety Profile

iStent inject® W is effective when implanted in conjunction with cataract surgery or as a stand-alone procedure in patients who require intraocular pressure reduction1-3.

iStent inject® Trabecular Micro-Bypass Instertion illustration.

Mechanism of Action

iStent inject® Trabecular Micro-Bypass Instertion illustration.

Delivering two preloaded trabecular micro-bypass stents with a single entry, iStent inject® W is designed to optimise the benefits of Trabecular Micro-Bypass surgery. The iStent inject® W device is designed to improve aqueous outflow through the natural physiological outflow pathway. When the device is implanted in the trabecular meshwork, it is designed to stent open that section of the ocular anatomy to allow aqueous humor to flow from the anterior chamber into Schlemm’s canal. A natural episcleral back pressure of 8-11 mm Hg in the trabecular meshwork reduces the risk of hypotony.4

iStent inject® Trabecular Micro-Bypass Instertion illustration.

Watch How It Works

The iStent inject® W Procedure

iStent inject® W is inserted ab interno through a microincision, which may be the phaco incision if performed in conjunction with cataract surgery, and can be performed under topical anaesthesia.

Tilt the patient’s head up to 25° away from the surgeon and tilt the microscope up to 35° toward the surgeon to obtain proper anterior chamber angle viewing

Adjust the microscope (10-12x) and locate the trabecular meshwork

Deepen the anterior chamber with a cohesive viscoelastic as needed
Enter the eye with the inserter through a clear corneal incision and advance past the pupillary margin
Place the trocar through the centre or slightly anterior portion of the trabecular meshwork and into the back wall of Schlemm’s canal
Dimple the tissue enough to see a “V” when pressing on trabecular meshwork
Squeeze the stent delivery button, but keep your finger on the stent delivery button while pulling back from the implanted stent
Move 2 to 3 clock hours away and implant the second stent using the same technique
Diagram of the iStent inject W.
The iStent delivery handpiece - the injector system.
Three close ups: iStent inject W stents, insertion tube with window, and insertion sleeve tip.

Focused on Excellent Outcomes

See the latest clinical data around iStent inject® W patient outcomes.

View Clinical Data

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References

  1. Hengerer FH. Personal Experience with Second-Generation Trabecular Micro-Bypass Stents in Combination with Cataract Surgery in Patients with Glaucoma: 3-Year Follow-up. ASCRS 2018 Presentation.
  2. Samuelson TW. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. March 2011;118(3):459-467.
  3. Voskanyan L, García-Feijoó J, Belda J, Fea A, Jünemann A, Baudouin C. “Prospective, Unmasked Evaluation of the iStent inject System for Open-Angle Glaucoma: Synergy Trial”. Adv Ther 2014; 31:189-201.
  4. Rosenquist R, Epstein D, Melamed S, Johnson M, Grant WM. Outflow resistance of enucleated human eyes at two different perfusion pressures and different extents of trabeculectomy. Curr Eye Res. 1989;8:1233-1240.

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iStent inject® W Important Safety Information

Indications for Use

The iStent inject® W is intended to reduce intraocular pressure safely and effectively in patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. The iStent inject® W, can deliver two (2) stents on a single pass, through a single incision. The implant is designed to stent open a passage through the trabecular meshwork to allow for an increase in the facility of outflow and a subsequent reduction in intraocular pressure.

The device is safe and effective when implanted in combination with cataract surgery in those subjects who require intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment with glaucoma medications and conventional glaucoma surgery.

Contraindications

The iStent inject® W System is contraindicated 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 such situations.
  • In patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.

Warnings/Precautions

  • For prescription use only.
  • This device has not been studied in patients with uveitic glaucoma.
  • Do not use the device if the Tyvek® lid has been opened or the packaging appears damaged. In such cases, the sterility of the device may be compromised.
  • Due to the sharpness of certain injector components (i.e. the insertion sleeve and trocar), care should be exercised to grasp the injector body. Dispose of device in a sharps container.
  • iStent inject® W is MR-Conditional; see MRI Information here.
  • Physician training is required prior to use of the iStent inject® W System.
  • Do not re-use the stent(s) or injector, as this may result in infection and/or intraocular inflammation, as well as occurrence of potential postoperative adverse events as shown below under “Potential Complications.”
  • There are no known compatibility issues with the iStent inject® W and other intraoperative devices (e.g., viscoelastics) or glaucoma medications.
  • Unused product & packaging may be disposed of in accordance with facility procedures. Implanted medical devices and contaminated products must be disposed of as medical waste.
  • 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 treatment regimen to reduce intraocular pressure.
  • Patients should be informed that placement of the stents, without concomitant cataract surgery in phakic patients, can enhance the formation or progression of cataract.

Adverse Events

Please refer to Directions For Use for additional adverse event information.

Caution

Please reference the Directions For Use labelling for a complete list of contraindications, warnings and adverse events.

iStent inject® ISI