FDA has approved the Edwards Sapien M3 Transcatheter Mitral Valve Replacement System for prohibitive-risk patients with severe mitral regurgitation. This transseptally delivered system offers a true valve replacement option, supported by the ENCIRCLE trial data demonstrating significant MR reduction and improved outcomes. #FDA #MedicalDevice #Cardiology #StructuralHeart #MitralValve TMVR SapienM3 ENCIRCLETrial | Abdallah Othman