Boston Scientific touts 1-year stroke reduction results in Watchman non-valvular AF trial

Boston Scientific (NYSE:BSX) today released 1-year results from the Ewolution registry study of its Watchman left atrial appendage closure device, touting a high implant success rate and stroke reduction in patients with non-valvular atrial fibrillation patients. Data was presented today at the Heart Rhythm Society’s 39th Annual Scientific Sessions in Chicago. “We are pleased to see that these ‘real-world’ results reinforce the positive outcomes observed in our clinical trial program, despite the registry patients being older and sicker than those enrolled in our previous trials,” rhythm management & global health policy CMO Dr. Kenneth Stein said in a press release. The prospective, single-arm, multicenter Ewolution trial evaluated 1,025 patients with non-valvular AF at a high risk for stroke and systemic embolism, the Marlborough, Mass.-based company said. At 1-year post implantation, study results reported an 84% reduction in annual stroke rate as compared with predicted rates of untreated patients with similar risk profiles. The study also reported a 48% reduction in the annual rate of major bleeding as compared to predicted rates for patients on warfarin. “This impressively low ischemic stroke rate favors left atrial appendage closure as an important therapy for patients ineligible for long-term oral anticoagulation. The results further validate the utility of the Watchman device as an excellent alternative to anticoagulant the...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Clinical Trials Boston Scientific Source Type: news