In a letter from the FDA to medical device developer Atritech, the agency requested that a confirmatory study be performed to further prove the safety and effectiveness of the Watchman left atrial appendage (LAA) closure device.
The study would test the safety of the device in patients with atrial fibrillation who are at increased risk of stroke and are eligible for anticoagulation therapy.
Results of the PROTECT AF clinical trial that compared the Watchman device to other standard based care methods, such as warfarin (Coumadin, Bristol-Myers Squibb), were presented last week at the 59th annual American College of Cardiology’s scientific sessions.
The study, which enrolled 800 patients, found that after a two-year follow-up, risk of stroke, cardiovascular death and systemic thromboembolism decreased by 31 percent in patients treated with the Watchman compared to those treated with warfarin.
The Plymouth, Minn.-based Atritech said that it will be working with the FDA on the trial design and expect the study to begin later this year.