iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) FDA PMA
- Generic Name
- Intraocular pressure lowering implant FDA PMA
Identifiers
- PMA Number
- P170043 FDA PMA
- FDA Product Code
- OGO FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) is an intraocular pressure lowering implant classified as an intraocular pressure lowering device. It consists of two preloaded titanium (Ti6Al4V ELI) stents coated with stearalkonium heparin, designed to create micro-bypass channels in the trabecular meshwork to facilitate aqueous humor outflow and reduce intraocular pressure (IOP).
This device is supplied sterile and intended for single-use during cataract surgery in adult patients with mild to moderate primary open-angle glaucoma. It is approved under FDA PMA (P170043) and requires surgical implantation via a microincision. The stents are preloaded in a disposable injector, ensuring compatibility with standard cataract surgical procedures. No additional regulatory markings or MRI safety classifications are specified.
Frequently asked questions
What is the primary purpose of the iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) during cataract surgery?
The iStent inject is designed to reduce intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma when used alongside cataract surgery. It achieves this by creating micro-bypass channels in the trabecular meshwork, allowing aqueous humor to drain more efficiently.
How is the iStent inject Trabecular Micro-Bypass System supplied, and is it reusable?
The device is supplied sterile and preloaded into a disposable injector, ensuring compatibility with standard cataract surgical procedures. It is explicitly intended for **single-use only**, meaning each injector and its stents are meant to be used once during a single surgical procedure.
What materials are the stents made of, and how are they coated?
The stents are manufactured from titanium alloy (Ti6Al4V ELI) and are coated with **stearalkonium heparin**. This coating helps support biocompatibility and reduce the risk of clotting or inflammation during implantation.
What surgical approach is required to implant the iStent inject Trabecular Micro-Bypass System?
The stents are implanted via a **microincision** during cataract surgery. The preloaded injector is designed to integrate seamlessly with existing surgical workflows, allowing for precise placement without requiring additional incisions or complex techniques.
Are there any special storage requirements for the iStent inject Trabecular Micro-Bypass System before use?
Since the device is supplied **sterile**, it should be stored according to standard sterile medical device protocols—typically in a clean, dry environment away from direct sunlight or extreme temperatures. The preloaded injector should remain unopened until immediately before use to maintain sterility.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: iStent inject® W Surgery | Glaucoma Products | Glaukos, PDF 45-0176 Rev 1 0618.indd - glaukos.com, iStent infinite® | Glaucoma Products | Glaukos, iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) (P170043 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P170043 | Class III | Active |
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Manufacturer
- Manufacturer
- Glaukos Corporation
Sources (1)
- FDA PMA P170043 24 fields · synced Sep 18, 2026