China’s Peijia Medical Limited (HKG: 9996) has announced the enrollment of the first patient and the implantation in a regulatory clinical study for its HighLife transcatheter septal mitral valve replacement (TSMVR) system. This marks a significant step forward in the development and potential market approval of the device.
Study Design and Objectives
The single group target value, prospective, multicenter regulatory study is designed to assess the safety and efficacy of the HighLife TSMVR system in patients with moderate to severe or severe mitral regurgitation. The study will provide critical data to support the market filing for the device in China.
Licensing Deal and Product Features
In December 2020, Peijia Medical signed a licensing deal with France-based medical device firm HighLife SAS, securing exclusive rights to HighLife’s proprietary transcatheter mitral valve replacement products in China. The HighLife TSMVR system, currently undergoing a special review process in China, features a unique design that reduces the risk of perivalvular leakage and effectively minimizes the size of the delivery system. These innovations aim to improve procedural outcomes and patient safety.-Fineline Info & Tech
