Boston Scientific has received CE mark approval for an expanded indication of Watchman Left Atrial Appendage (LAA) Closure device, designed to capture any clots that may form in the appendage.
The Watchman device also reduces the risk of stroke and eliminates the need for long term use of blood thinning medications.
The CE mark approval of the Watchman device is based on results from the ASA Plavix (ASAP) study, which demonstrated a 77% reduction for ischemic stroke in patients contraindicated to warfarin.
In addition to ASAP study, PROTECT AF trial proved that 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 and the Continued Access PROTECT AF trial demonstrated improved procedural outcomes with experience.
Boston Scientific cardiac rhythm management group chief medical officer Kenneth Stein said the expanded indication for Watchman represents an advance for the patients who are at high risk of stroke, but who are unable to take conventional anticoagulant therapy.
"WATCHMAN continues to demonstrate that it is an effective therapy for preventing stroke in patients with atrial fibrillation." Stein added.