WASHINGTON — The Food and Drug Administration is restricting use of a medical device made by Stryker that props open clogged brain arteries, after reviewing studies suggesting the implant can actually increase stroke and death in some patients.
More from TODAY.com
Watch Pearl Jam's Eddie Vedder honor doctor onstage at concert
At Sunday night's Pearl Jam concert at Xcel Energy Center in St. Paul, Minnesota, fans came to see Eddie Vedder and his band.
- Former 'American Idol' contestant Joanne Borgella dies at 32
- ‘Marcel the Shell’ returns, remains adorable in so-cute-it-hurts video
- San Francisco radio station bans Lorde's 'Royals,' KC plays it hourly
- See sparks fly as fire hits 'Downton Abbey' in trailer for 5th season
- Watch Pearl Jam's Eddie Vedder honor doctor onstage at concert
The FDA approved the Wingspan stent in 2005 for patients with plaque-filled arteries in the brain, which can lead to stroke. The agency now says the device should be used only for a small segment of patients who have experienced multiple strokes but have not had any stroke symptoms in the last seven days.
The agency's announcement comes after Public Citizen, a public safety advocacy group, called on the agency to take the device off the market entirely. A petition filed by the group last year pointed to a recent study that found a 2.5-fold increase in stroke or death among patients with the Wingspan stent system, compared with patients taking blood-thinning medication alone.
In its announcement Wednesday, the FDA acknowledged those risks but said the device may still be beneficial to patients who have not responded to other therapies.
"After careful consideration of available safety information, the FDA believes this device should remain available for this specific subgroup of patients who have exhausted other options," said Dr. Jeffrey Shuren, director of the FDA's center for devices.
Wingspan consists of a small, mesh metal tube that is braced into place via inflatable tube, promoting blood flow through the arteries to the brain. The stent was approved under a special program that grants speedy approval to devices for rare diseases and conditions that affect less than 4,000 people in the U.S. each year. The device was first developed by Boston Scientific Corp. and later sold to Kalamazoo, Mich.-based Stryker Corporation.
Copyright 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.