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NEWS

HighLife Receives CE Mark Approval for Clarity Valve for Use with the HighLife TMVR System

Shots: HighLife received CE Mark approval for its HighLife Clarity Mitral Heart Valve for use with HighLife TMVR System for adults with symptomatic mod. to sev. or sev. mitral valve regurgitation (MR) who are unsuitable for surgery or transcatheter edge-to-edge repair Four-year follow-up of the first 35 consecutively treated pts showed durable valve performance, with…
August 28, 2026

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NEWS

The US FDA Approves Edwards Lifesciences’ SAPIEN M3 Mitral Valve Replacement System for Mitral Regurgitation

Shots: The US FDA has approved Edwards Lifesciences’ SAPIEN M3 transcatheter mitral valve replacement (TMVR) system as the transseptal transcatheter therapy for the treatment of symptomatic moderate-to-severe or severe mitral regurgitation (MR) SAPIEN M3 is indicated for pts unsuitable for surgery or transcatheter edge-to-edge repair (TEER) therapy, including those with mitral valve dysfunction associated with…
December 25, 2025

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