FDA Warns Against Off-label Use of Wingspan Stent System
The neurointerventional device for intracranial stenosis ups the risk of stroke and death when used for nonapproved indications.
Straying from the strict criteria governing use of the Wingspan stent system (Stryker) in patients with intracranial arterial stenosis can have dire consequences, the US Food and Drug Administration warned Thursday.
A postmarketing surveillance study called WEAVE, mandated in 2012 in response to safety concerns with the device stemming from the results of SAMMPRIS and other studies, has shown that the rate of stroke or death within 72 hours is much higher when Wingspan is used outside of approved indications (23.9% vs 2.6%), according to a new FDA communication.
Moreover, the rate of stroke without death was 19.6% in patients treated for nonapproved indications and just 1.3% in those with approved indications. All nine of the strokes in the former group occurred in the territory of the stented artery.
Still, the FDA said, Wingspan remains useful for a subset of patients.
“Based on the WEAVE study results and other available safety information, a very specific group of patients, consistent with the current FDA-approved indications and patient selection criteria . . . , may benefit from the use of Wingspan,” the agency said. “The FDA’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.”
Wingspan should only be used in patients who meet all of the following criteria, according to the FDA:
- Age between 22 and 80
- History of at least two prior strokes despite aggressive medical management
- Most recent stroke more than 7 days before planned use of Wingspan
- 70% to 99% stenosis due to atherosclerosis of the intracranial artery related to recurrent strokes
- Good recovery from a previous stroke and a modified Rankin Scale score of 3 or less prior to use of Wingspan
The stent system was approved through the Humanitarian Device Exemption pathway, which is reserved for devices used in the treatment or diagnosis of diseases or conditions affecting no more than 8,000 Americans each year.
“Generally, a patient may be treated with Wingspan only if the treating physician has received Institutional Review Board (IRB) approval to use the Wingspan at the clinical site,” the FDA noted.
US Food and Drug Administration. Use of the Stryker Wingspan stent system outside of approved indications leads to an increased risk of stroke or death: FDA safety communication. Published on: April 25, 2019. Accessed on: April 25, 2019.