FDA OKs Glaukos’ iStent for cataract surgery

World’s Smallest Medical Implant iStent Reduces Intraocular Pressure, Now Cleared in U.S.

The FDA just approved the smallest medical implant ever developed. The image you see is of a U.S. penny and the iStent from Glaukos (Laguna Hills, CA) laying on its surface, which is shorter than Abe Lincoln’s chin (actually 0.5 mm x 0.25 mm x 1.0 mm). The company calls the device the first “ab interno [from the inside] micro-bypass implant for the treatment of glaucoma.”

Specifically, the iStent is made from titanium and is indicated for “open-angle glaucoma in patients needing cataract extraction,” according to Christy Foreman, FDA’s director of the Office of Device Evaluation at the Center for Devices & Radiological Health.

From the product page with more details explaining how the implant functions:

Elevated or uncontrolled IOP is the number one risk factor for glaucoma. The primary cause of elevated eye pressure in patients with primary open-angle glaucoma is abnormality of the trabecular meshwork which creates resistance to outflow and back-up of aqueous humor. Up to 75% of resistance to outflow is located in the trabecular meshwork.

Implantation of the iStent bypasses the trabecular meshwork and is placed in Schlemm’s canal near the lower nasal quadrants. The lower nasal quadrants have a large presence of collector channels. The iStent creates a patent bypass through the trabecular meshwork and into Schlemm’s canal; thereby reestablishing physiological outflow.

The FDA approves Glaukos Corp.’s iStent trabecular micro-bypass system to reduce intra-ocular pressure during cataract surgeries.

MassDevice.com news

The FDA said it gave pre-market approval to Glaukos Corp. to market its iStent device in the U.S. for cataract surgeries.

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News Well, Optical / Ophthalmic, Pre-Market Approval (PMA), Regulatory/Compliance, Stents

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Source : http://www.massdevice.com/news/fda-oks-glaukos-istent-cataract-surgery

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