Post market trial of Wingspan Stent System shows benefits in intracranial atherosclerotic disease.

Results from the Wingspan StEnt System Post MArket SurVEillance Study (WEAVE Trial) of the Wingspan stent system, from Stryker, provide compelling evidence that more patients suffering from intracranial atherosclerotic disease (ICAD) may benefit from endovascular treatment with the Wingspan Stent System. Results from this FDA-mandated post-market surveillance trial showed that patients receiving on-label treatment with the Wingspan Stent System demonstrated a 2.6% observed rate of stroke or death, compared to the pre-specified rate for early success, which was established as 4.0% 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. Stryker's sponsored WEAVE Trial is a multi-center, prospective, post-market surveillance study designed to evaluate the rate of stroke or death within 72 hours of the procedure in patients treated with the Wingspan Stent System. Data were presented at the International Stroke Conference.