By Fineline Cube 
US medical device giant Edwards Lifesciences Corporation (NYSE: EW) has announced that it has received the CE mark in the European Union (EU) for its SAPIEN M3 mitral valve replacement system. This approval allows the device to be used for transcatheter treatment of patients with symptomatic moderate-to-severe or severe mitral regurgitation (MR) who are not candidates for surgery or transcatheter edge-to-edge (TEER) therapy.
Innovation and Clinical Evidence
The SAPIEN M3 system is the world’s first transcatheter valve replacement therapy designed to treat mitral regurgitation using a transfemoral approach. Clinical studies have demonstrated its effectiveness in reducing MR and improving patients’ quality of life. The therapy offers a new option for patients who previously had limited treatment choices due to surgical or TEER ineligibility.
Post-Market Surveillance
Edwards Lifesciences plans to initiate a five-year post-market clinical follow-up study to evaluate the SAPIEN M3 system in real-world settings. This study will provide additional data on the long-term safety and efficacy of the device, further supporting its use in clinical practice.-Fineline Info & Tech