The FDA said it gave pre-market approval to Glaukos Corp. to market its iStent device in the U.S. for cataract surgeries.
The federal watchdog agency said the iStent trabecular micro-bypass stent is the first device approved in the U.S. for use during cataract surgery to reduce pressure inside the eye (intraocular pressure) in adults with glaucoma and a cataract.
It’s a small titanium tube placed in the eye to allow ocular fluid to drain from the eye’s anterior chamber, thereby decreasing ointraocular pressure, according to a press release.
"The iStent is a new option that may be considered in the treatment of open-angle glaucoma in patients needing cataract extraction," said Christy Foreman, director of the Office of Device Evaluation at the Center for Devices & Radiological Health, in prepared remarks. "This option may be considered earlier in the disease process than some other types of surgical glaucoma treatments."
The FDA said it reviewed effectiveness data from a study of 240 eyes in 239 participants (1 participant had both eyes evaluated), plus safety data for those subjects and an additional 50 patients. After a year, 68% of participants with the iStent had the study target pressure of 21 millimeters of mercury or lower without the use of eye pressure-lowering medication, compared to 50% of participants who underwent cataract surgery alone.