FDA Gives Stryker Corp's Stent System New Restrictions

The use of Stryker Corp's Wingspan Stent System has been restricted for use for a smaller group of patients by the Food and Drug Administration.

The Wingspan Stent System, which was designed to open severely constricted arteries in the brain, is now being restricted to patients who suffer from reoccurring strokes. 

The Wingspan Stent System was approved for use in 2005 under Humanitarian Device Exemption (HDE) but recent information gathered through clinical studies, such as the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study , and it was found in some patients the use of the Wingspan system risks may not outweigh the benefits, including risks such as stroke and even death.

Under the HDE, devices are intended to diagnose and/or treat a condition that affects fewer than 4,000 people nationwide per year.

Following the analysis of the SAMMPRIS study, the clinical study supporting the HDE approval and the opinions of an advisory panel , the FDA concluded the stent system would be more beneficial for patients who suffer from frequently occurring strokes despite medical management, and who had not had any new strokes within the last seven days prior to the stent system treatment.

“Patient benefit is an important factor in agency decision-making,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “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.”

Advocacy groups such as Public Citizen, disapproved the decision made by the FDA to continue use of the stent system, despite its new indications for labeling. Public Citizen argues that although the FDA sets new limitation behind the use of the stent system, physicians are still able to use the drugs and devices as they see fit.

However, the FDA does warn physicians to carefully select patients after evaluating the most recent device labeling. Doctors and patients should discuss all risks and benefits linked to the use of the stent system.

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