August 09, 2012 -- The U.S. Food and Drug Administration today approved changes to the labeling for the Stryker Wingspan Stent System, including the indications for use. These changes, which the FDA outlined in a safety communication1 also issued today, specify a more limited group of patients who may benefit from the system. In addition, the safety communication also describes the new contraindications for the stent system, which is used to open narrowed arteries in the brain to prevent additional strokes.
There are currently few treatment options for severely narrowed arteries in the brain, also known intracranial stenosis. Reduced blood flow to the brain from narrowed or blocked arteries puts patients at serious risk of life-threatening stroke.
Since the FDA approved the stent system in 2005 under a Humanitarian Device Exemption (HDE), data collected in clinical studies, including the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study, suggest that, in some patients, using the Wingspan system may present a greater risk, including stroke and death, to patients than medical management alone. However, there are important differences among the participants enrolled in the SAMMPRIS study and those enrolled in the study that supported the HDE, and these differences influence patient benefit and risk.
After reviewing available data, including the SAMMPRIS study, the clinical study supporting HDE approval and the opinions of an advisory panel of experts held in March 2012, the agency determined that the Wingspan system remains an option for a more limited set of patients, specifically those with recurrent stroke despite medical management who have not had any new stroke symptoms within seven days prior to treatment with Wingspan.
“Patient benefit is an important factor in agency decision-making,” said Jeffrey Shuren, M.D., 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.”
The FDA approved Stryker’s labeling changes on August 8, 2012 which include revised indications for use, new contraindications and warnings, and a clear description of the risks of the device. Stryker will also enhance its physician training program for Wingspan. In addition, the FDA is requiring Stryker to conduct a postmarket surveillance study (section 522 study2).
The FDA recommends that physicians carefully select patients after reviewing the most recent device labeling. Patients should discuss all treatment options, and the risks and benefits associated with the use of the Wingspan stent system with their physician.
Devices approved under HDE are intended to treat or diagnose a disease or condition that affects fewer than 4,000 people in the United States per year. Based on information from clinical and preclinical studies, the FDA approved the Wingspan HDE.
For more information:
FDA: Medical Devices 3
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.