Stryker Wingspan Stent System: Safety Communication - Narrowed Indications for Use
AUDIENCE: Neurology, Surgery, Patients
ISSUE: The FDA is informing health care providers and patients that the indications for use and labeling for the Wingspan stent 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 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 with severe intracranial stenosis and recurrent stroke despite continued medical 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 of life-threatening stroke and have limited alternative treatment options. See the FDA Safety Communication for more detailed information.
BACKGROUND: Stryker’s Wingspan Stent System (“Wingspan”) 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.
The FDA approved Wingspan in 2005 as a Humanitarian Use Device (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.
RECOMMENDATION: Physicians should be aware that the Wingspan Stent System is approved by the FDA 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 (IRB). 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).
- Select patients carefully after reviewing the new device labeling.
- Become familiar with the design and results of the SAMMPRIS trial.
- If your patient experiences a complication following treatment with the Wingspan System, please file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Thoroughly review the revised training program 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 Safety Information and Adverse Event Reporting program.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[08/08/2012 - Safety Communication - FDA]