On June 30, at the Congenital and Structural Intervention Congress (CSI) 2017 in Frankfurt, LifeTech Scientific Corporation (Stock Code: 1302.HK) announced the launch of a 3-year global post-market surveillance (PMS) study for the LAmbreTM Left Atrial Appendage (LAA) Closure System. The study planned to enroll more than 500 patients from about 30 clinical centers in Europe, Asia and South America.
The company said the launch and successful execution of the study would build more and stronger clinical evidence on the safety and efficacy of the device and strengthen its market position in the area.
LAmbreTM LAA Closure System has the smallest delivery sheath profile in the market and strong fixation mechanism proven clinically to prevent the device from the dislodgement. The flexible proximal cover design and wide sizes range make the device less limited by various LAA anatomies compared to its competitors. The TiN coating on its proximal cover also could prevent nickel release and long term thrombus.
"New devices have been developed to make the procedure even safer and more effective. The LAmbreTM device is one of these new systems, with several major advantages", commented Prof. Horst Sievert on JIM 2017, who was the PI of LAmbreTM pre-market study in Europe and also the PI of the post-market surveillance study of the device.
LAmbreTM LAA Closure System obtained its CE mark in June 2016 and its CFDA approval in June 2017. "We are also about to start an IDE trial on LAmbreTM device in the US", LifeTech CEO Mr. Xie Yuehui said. "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."
