LifeTech received CE Mark approval for its LAmbre left atrial appendage (LAA) closure system , on 15 June 2016. This is the first CE marked LAA closure system from China.
LAA closure is considered as an alternative to anticoagulation in atrial fibrillation patients at risk of stroke. The recent multicenter study indicated that LAA closure is superior to anticoagulation on stroke prevention, bleeding complications and mortality. The LAmbreTM LAA closure system was designed to close LAA percutaneously through a small 8-10 Fr sheath. The main design of the device consists of a distal umbrella and a proximal cover disc connected by a short sleeve.
LAmbreTM LAA closure device is fully recapturable and repositionable. It is safe with its patented anchor design to ensure the stability of the device in LAA. It is also easy to learn and use for physicians. Dr. David Zhang, CTO of LifeTech said ” The device can be easily implanted regardless of LAA anatomy. No device embolization was observed in our clinical trials.”
Currently, only few LAA closure devices obtained CE Mark approval, including Watchman (Boston Scientific) and ACP (St. Jude Medical, acquired by Abbott). The CE mark of LAmbreTM is expected to provide more choice to physicians and patients all over the world and help increase the LAA closure acceptance in the field. LifeTech is also actively pursuing the approval of LAmbreTM LAA Closure System in China and US market.
“We are proud of the CE mark of the first LAA Closure system from China and confident that our LAmbreTM LAA closure system can compete in the global market, bringing a superior solution to both physicians and patients,” said Mr. Yuehui Xie, Chairman and CEO of LifeTech.