HighLife SAS, a medical technology company focused on the development of a unique transcatheter mitral valve replacement (TMVR) system to treat patients suffering from mitral regurgitation, today announced CE Mark approval for the HighLife Clarity Mitral Heart Valve for use with the HighLife TMVR System.
The Clarity Valve helps mitigate left ventricular outflow tract obstruction (LVOTO)-related anatomical concerns while preserving HighLife’s transfemoral valve-in-ring architecture.
The approval covers both Clarity Valve Sizes – the HighLife standard Clarity Valve and the HighLife LAV Clarity Valve, maintaining the HighLife TMVR System’s ability to treat a native mitral annulus range of 30–53 mm — the broadest range of any CE Mark–approved TMVR system.
The Clarity Valve is approved for use in adult patients with symptomatic moderate-severe or severe mitral valve regurgitation (MR), who are deemed unsuitable for surgical repair or replacement and transcatheter edge-to-edge repair by a multidisciplinary heart team.
The CE Mark approval of the Clarity Valve builds on the initial CE Mark approval of the HighLife TMVR System announced in January 2026.
