FDA Revises Indications for Use of Stryker's Wingspan Stent System

August 8, 2012—The US Food and Drug Administration (FDA) announced that it has approved changes to the labeling for the Wingspan intracranial stent system (Stryker Corporation, Kalamazoo, MI), including the indications for use, new contraindications and warnings, and a clear description of the risks of the device. The FDA is also requiring Stryker to conduct a postmarket surveillance study. The changes are outlined in an FDA safety communication. Stryker acquired Boston Scientific Corporation's (Natick, MA) neurovascular business, including the Wingspan stent system, in January 2011.

According to the agency's press release, the FDA 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 7 days before treatment with Wingspan.

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. There are currently few treatment options for severe intracranial stenosis, noted the FDA in its announcement. 

The Wingspan is currently available through a humanitarian device exemption (HDE) that was approved by the FDA in 2005 based on information from clinical and preclinical studies. The agency noted that devices approved under an HDE are intended to treat or diagnose a disease or condition that affects fewer than 4,000 people in the United States per year.

The change is a result of the FDA's review of available data, the clinical study supporting HDE approval, and the opinions of an advisory panel of experts held in March 2012.

According to the FDA, since the 2005 HDE approval of Wingspan, data collected in clinical studies, including the SAMMPRIS (Stenting vs Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) study, suggest that, in some patients, using the Wingspan system may present greater risks to patients, including stroke and death, 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.

“Patient benefit is an important factor in agency decision making,” commented 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.”