August 9, 2012 — The U.S. Food and Drug Administration (FDA) is informing healthcare providers and patients that the indications for use and labeling for the Stryker Wingspan Stent System have changed to limit the use of Wingspan to a narrow, select group of patients and conditions. These changes are based on analysis of the original humanitarian device exemption (HDE) clinical study, data from studies performed after the HDE approval was granted, and data from a clinical trial called the Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study.
After reviewing the available safety information, the FDA believes that a very specific group of patients may benefit from use of the device. Patients with severe intracranial stenosis and recurrent stroke despite continued medical management (and who have not had any new symptoms of stroke within the 7 days prior to planned treatment) may benefit from Wingspan. The agency’s assessment of benefits and risks for this device considered that these patients are at serious risk of life-threatening stroke and have limited alternative treatment options.
The FDA approved Wingspan in 2005 as an HDE for patients with treatment-resistant (refractory) intracranial atherosclerotic disease who have 50 percent or greater narrowing in the intracranial arteries. HDE devices are intended to treat or diagnose a disease or condition that affects fewer than 4,000 people in the United States per year.
Stryker’s Wingspan Stent System is used to open narrowed arteries in the brains of patients diagnosed with intracranial stenosis who are experiencing repeated strokes. Stenosis, or narrowing of the intracranial arteries, is a serious condition caused by a buildup of plaque within the arteries, and there are few treatment options available for managing this condition. Patients with intracranial stenosis are at serious risk of life-threatening strokes due to reduced blood flow to the brain from narrowed or blocked arteries. The Wingspan stent is intended to reopen narrowed arteries in certain patients to potentially prevent additional strokes.