HighLife’s Clarity Valve for the HighLife TMVR System Approved in Europe

August 28, 2026—HighLife SAS, a France-based developer of a transcatheter mitral valve replacement (TMVR) system to treat patients with mitral regurgitation, announced CE Mark approval for the company’s HighLife Clarity mitral heart valve for use with the HighLife TMVR system.

HighLife stated that the European approval of the Clarity valve builds on the initial CE Mark approval of the HighLife TMVR System announced in January 2026. The HighLife TMVR system, including the Clarity valve, is being introduced through a limited market release in select European regions.

The latest approval covers both device sizes: the standard Clarity valve and the large annulus valve (LAV) Clarity valve, maintaining the HighLife TMVR system’s ability to treat a native mitral annulus range of 30 mm to 53 mm, advised the company.

HighLife further noted that the Clarity valve is approved for use in adult patients with symptomatic moderate-severe or severe mitral valve regurgitation, who are deemed unsuitable for surgical repair or replacement and transcatheter edge-to-edge repair by a multidisciplinary heart team.

According to the company, the Clarity valve is designed to further mitigate left ventricular outflow tract obstruction-related anatomical concerns while preserving the HighLife system’s valve-in-ring architecture, subannular fixation concept, and transfemoral procedural approach.

In the United States, the HighLife TMVR system is not approved or available for commercial sale and is limited to investigational use under applicable regulatory approvals.

HighLife also expects to begin enrollment in a United States pivotal trial in Q3 2026.