|The FDA narrowed its list of approved indications for Stryker's Wingspan brain stent--courtesy of Stryker|
The FDA dramatically narrowed its list of approved indications for Stryker's ($SYK) Wingspan intracranial stent. The regulator also ordered new labeling changes to address safety concerns and placed tighter guidelines for an even smaller subgroup of approved candidates. But the agency stopped short of pulling the controversial product from the U.S. market altogether, where it has had approval since 2005 as a humanitarian use device for patients at serious risk of strokes.
"After careful consideration, the FDA believes this device should remain available for this specific subgroup of patients who have exhausted other options," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.
Previously, the FDA allowed Wingspan's use for patients with treatment-resistant (refractory) atherosclerotic disease with a 50% or higher narrowing in the intracranial arteries. Now, potentially eligible patients between ages 22 and 80 must also have had two or more strokes even with "aggressive medical management," with their most recent stroke occurring at least a week before their planned Wingspan treatment. Patients must also have 70% to 99% stenosis due to atherosclerosis of the intracranial artery related to the strokes, a much higher threshold than before.
Eligible candidates face other hurdles, such as having made good recovery from a previous stroke with a small degree of disability, and physicians are urged to not use the device to treat transient ischemic attacks. And the humanitarian use designation still stands, which means physicians can only use it if the respective healthcare facility's institutional review board signs off on the procedure first.
In announcing their decision, regulators said they carefully considered existing data, including information from the SAMMPRIS study, which suggested that some patients using Wingspan faced a greater risk of stroke or death than just using medication alone. But the FDA said it ultimately agreed with a panel of experts who met in March and concluded, in part, that Wingspan could still help a limited set of patients, including those who have had a series of strokes even with existing treatment.
In March, the FDA's neurological devices advisory committee generally sided with an FDA report that determined that the stent in general wasn't any better than blood thinners or other standard therapies to help prevent strokes. It urged the FDA to re-evaluate whether Wingspan should be sold in the U.S. at all, where it has been used to treat fewer than 2,000 patients annually who suffered multiple strokes due to intracranial artery blockage.
Stryker issued a statement to FierceMedicalDevices noting that it was "pleased with the Agency's decision as it allows patients with intracranial atherosclerotic disease who have exhausted all available treatment options under the care of a qualified health care provider continued access to this life saving humanitarian device."
The company also said it would work with physicians "help them better understand the narrowed indications for product use reflected in the new product labeling."
Editor's note: This story has been updated to include comments from Stryker in the seventh and eighth paragraphs.