The iStent Inject Becomes FDA-Approved

The Food and Drug Administration (FDA) has recently approved the use of iStent inject for glaucoma patients undergoing cataract surgery. Some of you may be familiar with the iStent and how it is used.

The original iStent is a single microscopic stent placed in the trabecular meshwork (eye drainage tissue) that helps improve the impaired outflow of internal eye fluid to the bloodstream. The device improves the intraocular pressure (IOP) reduction that occurs with routine cataract surgery, in patients with glaucoma. The original iStent was FDA-approved in 2012.

How is the iStent inject different?

Over the past several years, investigators outside the US were free to implant more than one iStent at a time. These investigators found greater IOP reduction in using two iStents than in using one. Additionally, the maker of iStent (Glaukos Corporation) came up with a second-generation iStent, G2, that is easier to implant consistently – even for a novice surgeon.

An FDA trial investigated the implantation of two G2 stents at the time of cataract surgery, in patients with mild to moderate Primary Open Angle Glaucoma. The two-year follow-up study found even greater IOP reduction with the iStent inject system with cataract surgery, than with cataract surgery alone – safety being equal between the two groups.

This has resulted in the iStent inject being approved use within the US, and it will be commercially available later in 2018. Of course, the actual availability is dependent on third party payers’ (Medicare and commercial insurance) willingness to cover the costs. Historically, this has resulted in some delays in availability for a few to several months.

As with the original iStent, Stiles Eyecare Excellence (SEE) was one of the investigator sites within the FDA trial of iStent inject. Therefore, the surgeons and staff at SEE already have a few years experience using the device, and we will be willing and ready to offer you this exciting technology with unrivaled expertise.

If you are interested in learning more about the use of iStent inject and cataract surgery in the treatment of glaucoma, please give us a call or schedule an appointment today.

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