European regulators have approved an expanded indication for the Boston Scientific Corporation (NYSE: BSX) 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.
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 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.