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.
"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."
In addition, the European Society of Cardiology (ESC) today announced the inclusion of LAA closure devices in the revised "Guidelines for Management of Patients with Atrial Fibrillation." The recommendation was based on the expansive WATCHMAN LAA closure device clinical data, collected on more than 2,000 patients and exceeded the equivalent of 4,000 patient years of follow up across multiple studies. These studies include the PROTECT AF trial, which proved the WATCHMAN device was non-inferior to warfarin and demonstrated a 38 percent relative risk reduction for stroke, cardiovascular death and systemic embolism compared to long-term warfarin therapy; the ASA Plavix (ASAP) Registry, which demonstrated a 77 percent reduction for ischemic stroke in patients contraindicated to warfarin; and the Continued Access PROTECT AF trial, which demonstrated improved procedural outcomes with experience.
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 U.S., 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. Please visit https://www.bostonscientific.com/watchman for more information.
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About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
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