LifeTech Scientific Chinese developer LifeTech Scientific said today it won CE Mark approval in the European Union for its LAmbre left atrial appendage closure system, touting it as the 1st Chinese-developed LAA closure system to receive such approval.

The LAmbre system is designed for the closure of the LAA percutaneously through a small 8 to 10 Fr sheath, and consists of a distal umbrella and a proximal cover disc connected by a short sleeve, LifeTech said. The device is fully recapturable and repositionable, the company added.

The company touted a recent multicenter study which indicated LAA closure as superior to anticoagulation for stroke prevention, bleeding complications and mortality.

LifeTech said it is also actively pursuing regulatory approval for the LAmbre system in both China and the U.S.