Stryker Corp.’s Wingspan brain stent will be limited to use by a smaller group of patients than U.S. regulators initially approved and the device will now require post-market monitoring, U.S. regulators said.
The stent used to open severely narrowed arteries in the brain is being restricted to patients who have had recurring strokes despite medical management and haven’t had new stroke symptoms within seven days before treatment with Wingspan, the Food and Drug Administration said today in a statement.
The FDA cited data collected since approving the device in 2005 that suggest some patients using Wingspan may have a greater risk of stroke and death than those attempting medical management. The stent, used in fewer than 4,000 people in the U.S. each year, is meant to help prevent strokes caused by reduced blood flow to the brain.
“Patient benefit is an important factor in agency decision-making,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement. “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.”
Stryker fell less than 1 percent to $52.99 at the close of New York trading.
The FDA had approved Wingspan under a humanitarian device exemption that requires Kalamazoo, Michigan-based Stryker to prove the product doesn’t cause significant risk of illness or injury.