The US Food and Drug Administration (FDA) has announced changes to the labeling, including to the indications for use of the Wingspan stent (Boston Scientific/Stryker), which limit its use to a narrow, select group of patients diagnosed with intracranial stenosis.
The FDA approved Wingspan in 2005 under a humanitarian device exemption (HDE) for patients with treatment-resistant (refractory) intracranial atherosclerotic disease who have 50% or greater narrowing in the intracranial arteries.
According to an FDA release, the changes were based on an analysis of the original HDE clinical study and data from the SAMMPRIS (Stenting vs. aggressive medical management for preventing recurrent stroke in intracranial stenosis) study.
“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‰Û¥who have not had any new symptoms of stroke within the 7 days prior to planned treatment with Wingspan‰Û¥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,” states the FDA.
The FDA recommends: “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 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 (TIAs).”
The FDA makes specific recommendations for:
- Select patients carefully after reviewing the new device labeling.
- Become familiar with the design and results of the SAMMPRIS trial.
- If the patient experiences a complication following treatment with the Wingspan System, the FDA recommends to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Thoroughly review the revised training programme for Wingspan. A summary of these changes are included in the new labeling Instructions for Use.
- Report any device problems to the FDA through MedWatch.
The FDA also encourages healthcare professionals and patients to report adverse events or side effects related to the use of this product to the FDA’s MedWatch.