Results Published From Postmarket WEAVE Study of Stryker's Wingspan Stent System
February 28, 2019—Results of the WEAVE postmarket surveillance study mandated by the FDA to assess the periprocedural safety of the Wingspan stent system (Stryker) for the treatment of symptomatic intracranial atherosclerotic disease (ICAD) were published by Michael J. Alexander, MD, et al online ahead of print in Stroke.
As summarized in Stroke, a total of 152 consecutive patients who met the FDA on-label usage criteria were enrolled at 24 hospitals and underwent angioplasty and then stenting with the Wingspan stent.
On-label criteria included age 22 to 80 years, symptomatic intracranial atherosclerotic stenosis of 70% to 99%, baseline modified Rankin Scale score ≤ 3, two or more strokes in the vascular territory of the stenotic lesion with at least one stroke while on medical therapy, and stenting of the lesion ≥ 8 days after the last stroke. The primary analysis assessed the periprocedural stroke, bleed, and death rate within 72 hours of the procedure with adjudication by a core study stroke neurologist.
The WEAVE investigators reported that the study was stopped early after an interim analysis of 152 consecutive patients demonstrated a lower than expected 2.6% (4/152 patients) rate of periprocedural stroke, bleed, and death. The periprocedural primary event safety benchmark set for the interim analysis in the study was 4%. The investigators also found that 97.4% (148/152) of patients were event free at 72 hours, 1.3% (2/152) had nonfatal strokes, and 1.3% (2/152) died.
The investigators concluded that with experienced interventionalists and proper patient selection following the on-label usage guidelines, use of the Wingspan stent for ICAD demonstrated a low periprocedural complication rate and excellent safety profile. This is the largest on-label, multicenter, prospective study of the Wingspan stent system to date with the lowest reported complication rate, noted the WEAVE investigators in Stroke.
Last year, Stryker announced the presentation of the WEAVE results at the ISC 2018: the International Stroke Conference held January 24–26 in Los Angeles, California. Wingspan is a self-expanding stent and delivery system intended for use in the treatment of ICAD.
According to the company, the findings provide compelling evidence that more patients with ICAD may benefit from endovascular treatment with the Wingspan stent system.The device includes the over-the-wire Gateway percutaneous transluminal angioplasty balloon catheter that predilates the lesion before insertion and deployment of the Wingspan stent.
The Wingspan stent system was approved under an FDA humanitarian device exemption in 2005. Wingspan also received European CE Mark approval in 2005, the company noted.