LifeTech, at the 2017 Congenital and Structural Intervention Congress (CSI; 28 June—1 July, Frankfurt, Germany), announced the launch of a three-year global postmarket surveillance study for the LAmbre left atrial appendage (LAA) closure system. A press release reports that the aim is to enrol more than 500 patients from about 30 clinical centres in Europe, Asia and South America.
The press release adds that LifeTech hopes that the launch and successful execution of the study will build more and stronger clinical evidence on the safety and efficacy of the device and strengthen its market position in the area. Also, it says that the LAmbre LAA closure system has the smallest delivery sheath profile on the market and strong fixation mechanism proven clinically to prevent the device from the dislodgement. The flexible proximal cover design and wide sizes range have been developed to make the device less limited by various LAA anatomies compared with its competitors. The TiN coating on its proximal cover also could prevent nickel release and long-term thrombus.
The principal investigator of postmarket study, speaking at JIM 2017, Horst Sievert (CardioVascular Center Frankfurt CVC, Frankfurt, Germany) commented: “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.”
LAmbre LAA closure system obtained its CE mark in June 2016 and its China FDA approval in June 2017. LifeTech chief executive officer Xie Yuehui says: “We are also about to start an IDE trial on LAmbreTM device in the USA. 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.”