HighLifeHighLife TMVR System

The HighLife TMVR System is a transfemoral transcatheter mitral valve replacement platform for adults with symptomatic moderate-severe or severe mitral regurgitation who are unsuitable for surgical repair or transcatheter edge-to-edge repair. Its valve-in-ring concept implants a sub-annular ring and a replacement valve percutaneously, mimicking the surgical gold standard, and treats a native mitral annulus range of 30 to 53 mm.

The system received CE Mark approval in January 2026 and entered phased commercial introduction across Europe, while the next-generation Clarity valve, approved in August 2026, adds an open-cell outflow design that further mitigates LVOTO-related anatomical concerns. In the United States the system remains investigational, supported by FDA Breakthrough Device designation granted in April 2025 and an IDE approval for a pivotal clinical study.