Postmarket WEAVE Study Presented for Stryker's Wingspan Stent System to Treat Intracranial Atherosclerotic Disease
January 30, 2018—Stryker announced that results from WEAVE, the postmarket surveillance study of the company's Wingspan stent system, were presented at the ISC 2018: the International Stroke Conference held January 24–26 in Los Angeles, California.
According to the company, the findings provide compelling evidence that more patients with intracranial atherosclerotic disease (ICAD) may benefit from endovascular treatment with the Wingspan stent system.
Wingspan is a self-expanding stent and delivery system intended for use in the treatment of ICAD. It includes the over-the-wire Gateway percutaneous transluminal angioplasty balloon catheter that predilates the lesion before insertion and deployment of the Wingspan stent.
The WEAVE study was mandated by the US Food and Drug Administration, which approved the Wingspan stent system under a humanitarian device exemption in 2005. Wingspan also received European CE Mark approval in 2005.
The company-sponsored, multicenter, prospective WEAVE study is designed to evaluate the rate of stroke or death within 72 hours of the procedure in patients treated with the Wingspan stent system.
Stryker reported that patients receiving on-label treatment with the Wingspan system demonstrated a 2.6% observed rate of stroke or death, compared to the prespecified rate for early success, which was established as 4% with a minimum 150 patients. These results are significant when compared to the study's null hypothesis with high predictive probability (> 95%) that the true rate is 9.7% and suggest that endovascular treatment of ICAD patients receiving on-label use of the Wingspan stent may provide promising results, advised the company.
The WEAVE study's Principal Investigator, Michael Alexander, MD, commented in the company's announcement, "These trial results have the potential to change how stroke patients are treated in the future. Using approved stents in the brain arteries may give new hope to patients suffering from stroke due to blockages from cholesterol plaque." Dr. Alexander is Director of the Neurovascular Center at Cedars-Sinai in Los Angeles, California.
Stryker stated that the WEAVE investigators believe the final results from the trial may lead to a critical shift in how physicians approach patient selection for endovascular therapy for ICAD.
In the United States, the Wingspan stent system with Gateway percutaneous transluminal angioplasty balloon catheter is authorized by for use in improving cerebral artery lumen diameter in patients who are 22 to 80 years of age with recurrent (two or more) strokes refractory to a comprehensive regimen of medical therapy and caused by atherosclerotic disease of intracranial vessels with 70% to 99% stenosis that are accessible to the system. The most recent stroke must have occurred more than 7 days before treatment with the Wingspan stent system. Patients are eligible for treatment with the Wingspan stent system if their modified Rankin score is ≤ 3 at the time of treatment. The effectiveness of this device for this use has not been demonstrated, advised the company.