Boston Scientific Cardiac Device Gets Expanded Indication in Europe

Boston Scientific Corp. has received approval from European regulators for an expanded indication for Watchman Left Atrial Appendage (LAA) Closure Device. The new indication offers patients with atrial fibrillation (AF) and a contraindication to warfarin (and newer oral anticoagulants) a new treatment option for stroke reduction.

Atrial fibrillation affects approximately 15 million patients worldwide and is a disorder that disrupts the ability of the heart to beat regularly and pump blood efficiently. Patients in AF have an increased risk of stroke due to the migration of clots formed in the LAA. Blood-thinning medications previously have been the only therapy for reducing stroke risk in these patients.

The Watchman device was granted CE Mark approval based on results from the ASAP (ASA Plavix) trial. Watchman is a device introduced into the heart via a flexible catheter through a vein in the groin intended to close off the LAA. The device is designed to capture any clots that may form in the appendage, reducing the risk of stroke and potentially eliminating the need for long-term use of blood thinning medications.

“The expanded indication for Watchman represents a significant advance for these patients who are at high risk of stroke, but who are unable to take conventional anticoagulant therapy,” said Kenneth Stein, M.D., chief medical officer of Boston Scientific’s Cardiac Rhythm Management Group. “Watchman continues to demonstrate that it is an effective therapy for preventing stroke in patients with atrial fibrillation.”

As a result of clinical data collected on the Watchman device from more than 2,000 patients, the European Society of Cardiology announced the inclusion of LAA closure devices in the revised “Guidelines for Management of Patients with Atrial Fibrillation.”

The Watchman device was approved for use in Europe in 2005 and some countries in Asia in 2009. Boston Scientific recently completed enrollment in the PREVAIL study, a confirmatory study designed to gain U.S. Food and Drug Administration approval. Patient follow up for the study is six months. In the United States, the Watchman device is an investigational device, limited by applicable law to investigational use and not available for sale. The device was developed by Atritech, which Boston Scientific acquired in March 2011.

Boston Scientific is headquartered in Natick, Mass., with European headquarters in Nanterre, France.