By Fineline Cube 
Medical device firm HighLife SAS, the French partner of China-based Peijia Medical Limited (HKG: 9996), announced that it has received Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA) for its novel trans-septal mitral valve replacement (TMVR) system. This designation highlights the system’s potential in addressing moderate to severe mitral regurgitation (MR), a condition affecting a significant patient population globally.
Clinical Evaluation
The TMVR system is currently under clinical evaluation in Europe, Asia Pacific, and the US. This innovative solution was exclusively licensed to Peijia Medical for Greater China in December 2020, with the technology transfer successfully completed, marking a significant step in the global development of this promising medical device.-Fineline Info & Tech