Watchman LAAC device (Boston Scientific) receives expanded CE indication - 27-Aug-2012

European regulators have approved an expanded indication for the Boston Scientific Watchman Left Atrial Appendage (LAA) Closure Device. The new indication offers patients with atrial fibrillation (AF), and a contraindication to warfarin and the newer oral anticoagulants, a new treatment option for Stroke Reduction.

Patients in AF have an increased risk of stroke due to the migration of clots formed in the LAA. Blood-thinning medications have previously been the only therapy for reducing stroke risk in these patients.

This CE Mark approval of the Watchman device was based on results from the ASAP study. Watchman is a novel device introduced into the heart via a flexible tube (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.In addition, the European Society of Cardiology (ESC) announced the inclusion of LAA closure devices in the revised "Guidelines for Management of Patients with Atrial Fibrillation.

Boston Scientific recently completed enrollment in the PREVAIL study, a confirmatory study designed to gain FDA approval. Patient follow up for the study is six months.