Boston Scientific Corp. completed enrollment in the PREVAIL (Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) study to support a premarket approval (PMA) for its Watchman left atrial appendage closure device, the company announced July 2. The 42-site, prospective, randomized trial enrolled 407 patients with atrial fibrillation at a high risk for stroke who were eligible for long-term anticoagulant warfarin therapy, comparing treatment with the stroke-reduction device to warfarin.
Boston Scientific initiated PREVAIL in 2010 as a confirmatory study after the Food and Drug Administration said it would not approve the device based on the already-completed, 700-patient pivotal PROTECT (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial. In April, Boston Scientific said it expects to submit a PMA for Watchman by the end of the year. The device was approved in Europe in 2005. In recent results reported by the company for Watchman, the device showed promise in preventing stroke in high-risk patients with atrial fibrillation who are contraindicated for warfarin.
This story appears courtesy of "The Gray Sheet," a weekly Elsevier publication covering the medical device and diagnostic industries. To learn more, contact customer care at 800-332-2181 or sign up for a free trial.