First Commercial Procedures in the United States Performed With Boston Scientific's Watchman Device

March 24, 2015—Boston Scientific Corporation announced the initial commercial use of its Watchman left atrial appendage closure device, which offers a novel reduced stroke risk option for high-risk patients with nonvalvular atrial fibrillation (AF) as an alternative to long-term warfarin therapy. On March 13, the company announced that the Watchman device was approved by the US Food and Drug Administration.

Four patients underwent the first Watchman device implantations in the United States. The procedures were performed by Shephal K. Doshi, MD, Director of Cardiac Electrophysiology and Pacing at Saint John’s Health Center in Santa Monica, California, and Saibal Kar, MD, Director of the Cardiovascular Intervention Center Research at Cedars-Sinai Hospital in Los Angeles, California.

In Boston Scientific’s press release, Dr. Kar commented, “With today’s successful implantations of the Watchman device, we are changing the way we deal with stroke risk in high-risk patients with nonvalvular AF. For indicated patients like those who received an implant this week, the Watchman device reduces the risk of stroke, without the need for long-term anticoagulation therapy and its subsequent bleeding risks.”

Dr. Doshi added, “As physicians, we are always looking for new therapies to satisfy unmet patient needs. There are many patients like the ones we treated this week with the Watchman device who are suitable for warfarin, but are not ideal candidates for chronic anticoagulant use. These patients now have a new, proven option to reduce their risk of AF-related stroke.”

Boston Scientific advised that the Watchman device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with nonvalvular AF who are at an increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are deemed by their physicians to be suitable for warfarin, and have an appropriate rationale to seek a nonpharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.