A postmarket surveillance study has found a significantly higher incidence of stroke or death when the Wingspan Stent System (Stryker) is used outside the US Food and Drug Administration (FDA) approved indications, the agency has warned in a safety communication issued today.
Based on the WEAVE study results and other available safety information, "a very specific group of patients, consistent with the current FDA-approved indications, may benefit from the use of Wingspan," the FDA said.
The Wingspan Stent System combines a percutaneous transluminal angioplasty balloon catheter with a self-expanding neurovascular, nitinol stent and stent delivery system. It was approved in 2005 to treat intracranial atherosclerotic disease (ICAD) under the Humanitarian Device Exemption (HDE).
"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," the agency said.
The Wingspan system is approved only for use in patients aged 22 to 80 years who have atherosclerotic disease of intracranial vessels with 70% to 99% stenosis, have experienced two or more strokes, have not responded to medical management, and scored 3 or less on the modified Rankin Scale (mRS).
The FDA-mandated WEAVE postmarket study was conducted to further assess the rates of stroke or death within 72 hours of the Wingspan Stent placement procedure.
Among 198 patients who received Wingspan in the study, 152 met FDA-approved indications for use criteria and 46 did not. There was a higher incidence of stroke or death within 72 hours of the procedure when the Wingspan was used in patients outside of the FDA-approved indications for use.
Outcomes Within 72 Hours for On- vs Off-Label Use of Wingspan System
|Outcome||On-Label Use (n = 152)||Off-Label Use (n = 46)|
|Death, n (%)||2 (1.3)||2 (4.3)|
|Stroke Without Death, n (%)||2 (1.3)||9 (19.6)|
|Total With Stroke or Death, n (%)||4 (2.6)||11 (23.9)|
|Total Without Stroke or Death, n (%)||148 (97.4)||35 (76.1)|
All nine strokes (seven ischemic) occurred in the territory of the stented artery. Treatment with Wingspan outside of the FDA-approved indications included having the procedure less than 7 days since the last stroke (four patients); less than two qualifying strokes (three patients); mRS score of four or five (three patients); being not refractory to medications (one patient); and the treatment was unrelated to ICAD (one patient). Patients may have had more than one condition outside of the FDA-approved indications.
The FDA encourages clinicians to carefully consider patient selection after reviewing the approved labeling including the indications for use, contraindications, warnings, and precautions.
The FDA is working with Stryker to revise the Wingspan labeling to ensure all providers are aware of the increased risk of stroke and death when used outside the FDA-approved indications for use, the agency notes.
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Cite this: FDA Warns of Stroke, Death With Off-Label Use of Wingspan Stent - Medscape - Apr 25, 2019.