LifeTech Scientific said this week it is launching a 3-year post-market surveillance study of its LAmbre left atrial appendage closure system.
The Chinese developer said it plans to enroll 500 patients in the study at 30 clinical centers across Europe, Asia and South America.
“New devices have been developed to make the procedure even safer and more effective. The Lambre device is one of these new systems, with several major advantages” trial primary investigator Horst Sievert said in a prepared statement.
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 also about to start an IDE trial on Lambre device in the US. The clinical safety records and the advanced design of the device make us very confident to survive and grow from the head to head competition in the area,” CEO Xie Yuehui said in a prepared statement.
LifeTech Scientific won CE Mark approval in the European Union for the device last June, touting it as the 1st Chinese-developed LAA closure system to receive such approval.