Boston Scientific's Watchman Device Ready To Enter U.S. Market

The device, which has been in markets outside of U.S. since 2005, has struggled to gain approval after complications stemming from efficacy and complexity during implantation. The device was finally able to satisfy the FDA following the results of the company's PROTECT AF and PREVAIL trial, which established that the Watchman device could reduce the incidence of stroke in patients who could not take the standard anticoagulant, warfarin, due to its side effects such as high risk of bleeding.