The FDA has informed health care providers and patients that the indications for use and labeling for the intracranial Wingspan Stent System have changed to limit use to a narrow, select group of patients and conditions, according to a safety communication issued by the agency.
The Wingspan Stent System (Stryker) is used to open narrowed arteries in the brains of patients diagnosed with intracranial stenosis who are experiencing repeated strokes. The FDA approved the device in 2005 as a Humanitarian Use Device (HDE) for patients with refractory intracranial atherosclerotic disease who have 50% or greater narrowing in the intracranial arteries.
The changes in use were based on analysis of the original HDE clinical study, data from studies performed after the HDE approval was granted and data from the Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study, which showed that the device may present unacceptable risks, such as stroke and death, to many patients previously considered appropriate for treatment with the stent, according to a press release.
“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 management — who have not had any new symptoms of stroke within the 7 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 for life-threatening stroke and have limited alternative treatment options,” the safety communication reads.
According to the FDA, the stent system is now approved only for patients aged 22 to 80 years who meet all of the following criteria:
- History of two or more strokes despite aggressive medical management.
- Recent stroke that occurred more than 7 days prior to planned treatment with the stent system.
- Those with 70% to 99% stenosis due to atherosclerosis of the intracranial artery related to the recurrent strokes.
- Those who have made good recovery from previous stroke and have a modified Rankin score of 3 or less prior to treatment with the stent system.