LONDON, June 16, 2016 /PRNewswire/ -- LifeTech (1302.HK) received CE Mark approval for its LAmbreTM 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 choices for 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 the China and US markets.
"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.
About LifeTech Scientific Corporation:
LifeTech Scientific Corporation (Stock Code: 1302.HK) specializes in R&D, manufacture and sales of minimally invasive interventional medical devices to treat cardiovascular and peripheral vascular diseases. The Company is the second largest supplier of occluders for congenital heart diseases globally (and largest among BRIC countries). In October 2012, the Company reached strategic cooperation with Medtronic, which is now a strategic shareholder of LifeTech. At present, the Company's innovative products with self-owned intellectual property are extensively marketed in 76 countries through more than 160 distributors.
LifeTech Scientific Corporation
SOURCE LifeTech Scientific Corporation