FDA narrows indication for Stryker's brain stent
These changes, according to the agency, are based on an analysis of the original human device exemption (HDE) clinical study, data from studies performed after the HDE approval was granted and data from the SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) trial, which was halted early in April 2011.
After reviewing the available safety information, the FDA "believes that a very specific group of patients with severe intracranial stenosis and recurrent stroke despite continued medical management -- who have not had any new symptoms of stroke within the seven days prior to planned treatment with Wingspan -- may benefit from the use of the device." 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.
Stryker’s Wingspan stent is used to open narrowed arteries in the brains of patients diagnosed with intracranial stenosis who are experiencing repeated strokes. 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, according to the FDA. The Wingspan stent is intended to reopen narrowed arteries in certain patients to potentially prevent additional strokes.
The FDA approved Wingspan in 2005 as a HDE for patients with treatment-resistant intracranial atherosclerotic disease who have 50 percent or greater narrowing in the intracranial arteries.
The Wingspan Stent System is FDA approved as a humanitarian use device. Generally, a patient may be treated with Wingspan only if its use has been approved in advance by the treating physician’s Institutional Review Board.
The agency noted that Wingspan Stent System should not be used for:
- The treatment of stroke with an onset of symptoms within seven days or less of treatment; or
- For the treatment of transient ischemic attacks.