UPDATE: Stryker has provided a response to the FDA decision:
Stryker is pleased to announce that we received communication from FDA concluding their review of the Wingspan Stent System and Gateway PTA Balloon Catheter (Wingspan Stent System) and having determined that the Wingspan Stent should remain available for those patients who have failed to respond to, or who are ineligible for, an aggressive and comprehensive program of medical management.
Stryker is pleased with the Agency’s decision as it allows patients with intracranial atherosclerotic disease who have exhausted all available treatment options under the care of a qualified health care provider continued access to this life saving humanitarian device.
Stryker is fully committed to partnering with our physician community to help them better understand the narrowed indications for product use reflected in the new product labeling.
The U.S. Food and Drug Administration effectively clipped the wings of Stryker’s Wingspan brain stent system and limited its use after reviewing clinical data that suggested the device may increase the risk of stroke and death in some patients compared with medical management alone.
Ironically, the device, used to open narrowed arteries in the brain, is aimed at preventing strokes caused by cranial stenosis. Many had wanted the device recalled altogether.
The device was approved under a Humanitarian Device Exemption in 2005. But after the FDA reviewed data from the clinical study used to approve the device and based on opinions of a panel of experts, the agency decided the device should be used on a smaller subsection of patients,especially those who suffer repeated stokes even with medical management, but those who have not had stroke symptoms for a period of seven days before being treated with Wingspan.
Further, the FDA is requiring Stryker to conduct a postmarket surveillance study and provide additional information on contraindications on thelabeling.
Consumer advocacy group Public Citizen had requested an immediate withdrawal of the product.
“Patient benefit is an important factor in agency decision-making,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a 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.”
An HDE is granted to a device intended to treat or diagnose a condition that affects less than 4,000 people in the U.S. annually.
A Stryker spokeswoman did not immediately respond to a request for comment.
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