Boston Scientific’s Watchman receives expanded EU approval

Boston Scientific has received European CE Mark approval for an expanded indication for its Watchman left atrial appendage closure device.

The expansion will allow patients with atrial fibrillation who are contraindicated to warfarin and newer oral anticoagulants to receive a new stroke reduction treatment option.

Data from the clinical trial ASAP showed that Watchman, which is introduced into the heart via a flexible tube through a vein in the groin, is able to capture clots that form in the left atrial appendage, reducing the risk of stroke and potentially ensuring that long-term use of blood-thinning medications is not needed.

Watchman has been available for sale in Europe since 2005 and made its Asian debut in 2009, while Boston Scientific is also hoping to secure US approval for the device soon.

Dr Kenneth Stein, chief medical officer of Boston Scientific's cardiac rhythm management group, said: "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."

Earlier this month, the company also received CE Mark approval for its new Ingenio family of pacemakers.