Boston Scientific’s Watchman FLX atrial closure device receives CE Mark

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

The Watchman system is the most studied left atrial appendage closure device, and has been used to help reduce the risk of stroke for tens of thousands of high-risk patients with non-valvular atrial fibrillation as an alternative to long-term anticoagulant therapy.

This new iteration is the latest version of the product, offering a closed-end design and the ability to fully recapture and reposition this device, making it ideal for treating indicated patients with simple and complex anatomies.

Commercialisation of the device is currently restricted to a limited market release, with wider availability in approved EU countries planned for the first half of 2016.

Dr Kenneth Stein, chief medical officer for rhythm management at Boston Scientific, said: "We are pleased that this next-generation technology has been granted European regulatory approval and we can begin a controlled product rollout to clinicians throughout Europe."

This comes after the firm received CE Mark approval for its Vercise primary cell deep brain stimulation system in September.