Boston Scientific has received CE mark approval for its Watchman Left Atrial Appendage (LAA) Closure Device to be used in patients with atrial fibrillation (AF) and a contraindication to warfarin and the newer oral anticoagulants.
This CE mark approval of the Watchman device was based on results from the ASAP study. 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, 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) has 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% 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% reduction for ischaemic 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 enrolment in the PREVAIL study, a confirmatory study designed to gain US Food and Drug Administration approval. Patient follow-up for the study is six months. In the USA, 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.