Use Limited for Stryker Wingspan Stent System

The Food and Drug Administration (FDA) is informing health care providers and patients that the indications for use and labeling for Stryker’s Wingspan Stent System have changed to limit its use to a narrow select group of patients.

Wingspan is used to open narrowed arteries in the brains of patients diagnosed with intracranial stenosis—a serious condition caused by a buildup of plaque within the arteriea-- who are experiencing repeated strokes. Patients with intracranial stenosis are at serious risk of life-threatening strokes due to reduced blood flow to the brain from narrowed or blocked arteries.

After reviewing the available safety information, the FDA believes that only a very specific group of patients with severe intracranial stenosis and recurrent stroke despite continued medical management may benefit from the use of the medical device.

The FDA approved Wingspan in 2005 as a Humanitarian Use Device (HDE) for patients with treatment- resistant intracranial atherosclerotic disease who have 50 percent or greater narrowing in the intracranial arteries.

HDE devices are intended to treat or diagnose a disease or condition that affects less than 4,000 people in the U.S. each year.

If you or a loved one has been harmed by an unsafe medical device, contact Sokolove Law for a free legal consultation and to find out if a product liability lawyer may be able to help you. For legal help, call (800) 581-6358.

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