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.
“We are proud of the CE mark of the first LAA closure system from China and confident that our LAmbre LAA closure system can compete in the global market, bringing a superior solution to both physicians and patients,” CEO Yuehui Xie said in a press release.
The company touted a recent multicenter study which indicated LAA closure as superior to anticoagulation for stroke prevention, bleeding complications and mortality.
“The device can be easily implanted regardless of LAA anatomy. No device embolization was observed in our clinical trials,” CTO Dr. David Zhang said in a prepared statement.
LifeTech said it is also actively pursuing regulatory approval for the LAmbre system in both China and the U.S.