"The results of the PREVAIL trial add to the wealth of previously published data confirming the utility of the WATCHMAN device as an option for the reduction of stroke in high risk patients," said Kenneth Stein, M.D., chief medical officer, Cardiac Rhythm Management, Boston Scientific. "WATCHMAN is the only device-based alternative to anticoagulation that has undergone rigorous scientific study. We are pleased the PREVAIL results showed low complication rates with both new and experienced operators and significantly lower complications than the early stage of the PROTECT AF trial."Data from the PREVAIL trial, complemented by the PROTECT AF four-year outcomes data, the WATCHMAN Pilot study six-year data, the ASAP study and the CAP registry data update will be submitted to support device approval by the U.S. Food and Drug Administration (FDA).
The Boston Scientific Watchman® Device Continues To Demonstrate Positive Clinical Outcomes For Patients With Atrial Fibrillation
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