Stryker icad3/28/2024 The FDA also wanted to look at the outcomes of those patients who were treated off-label at the same institutions that the trial was being carried out at. to date (n=152) and has the lowest reported periprocedural complication rate. It was the largest on-label enrolment of any stent trial for intracranial atherosclerotic disease (ICAD) in the U.S. The Wingspan stEnt system post mArket surVEillance (WEAVE) trial was an FDA mandated postmarket surveillance study funded by Stryker. Off-label use, particularly within seven days of stroke, appeared to significantly increase the risk of periprocedural stroke and death, increasing it to 23.9%. The trial data suggest that patients suffering from intracranial atherosclerotic disease may benefit from endovascular treatment with the Wingspan Stent System This was better than the FDA’s target of 4%. The final results showed that following on-label indications resulted in extremely low periprocedural stroke and death rate (2.6%) with Wingspan for FDA approved indication. A patient with a severe vertebral artery stenosis who was treated with a Wingspan stent
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