PARIS, FRANCE, Aug 27, 2026

HighLife SAS, a medical technology company developing transcatheter mitral valve replacement solutions, has received CE Mark approval for the HighLife Clarity Mitral Heart Valve, a next-generation valve designed for use with the company’s HighLife Transcatheter Mitral Valve Replacement (TMVR) System. The approval covers both the standard Clarity Valve and the HighLife LAV Clarity Valve, maintaining the platform’s ability to address a native mitral annulus range of 30–53 mm. The company said the new valve is designed to address one of the major anatomical challenges associated with TMVR: left ventricular outflow tract obstruction (LVOTO). The CE Mark decision follows the initial CE Mark approval of the HighLife TMVR System announced in January 2026 and supports a phased commercial introduction in selected European regions.

Clarity Valve Targets Key TMVR Anatomical Challenge

LVOTO risk remains an important consideration when physicians assess patients for transcatheter mitral valve replacement. Anatomical concerns involving the projected neo-LVOT can make some patients unsuitable for treatment and may contribute to screening failures despite significant clinical need. HighLife developed the Clarity Valve with an open-cell outflow design intended to help address these anatomical concerns. By reducing material coverage in the outflow portion of the valve frame, the design is intended to preserve a pathway for blood flow toward the left ventricular outflow tract while retaining the established HighLife valve-in-ring architecture, sub-annular fixation concept and transfemoral procedural approach. The approved device is intended for adults with symptomatic moderate-to-severe or severe mitral regurgitation (MR) who are considered unsuitable for surgical repair or replacement and transcatheter edge-to-edge repair by a multidisciplinary heart team.

Clinical Experience Supports Next-Generation Design

HighLife said clinical experience with the Clarity Valve has included evaluation of LVOT performance during follow-up, including independent core-laboratory assessment of LVOT gradients and analysis of the potential effects of left ventricular reverse remodeling on neo-LVOT anatomy. According to the company, clinical experience presented to date showed no LVOT obstruction at 30 days or one year, including in patients who experienced substantial reverse remodeling and had very small neo-LVOT areas. These findings provide clinical context for the open-cell design and its intended role in addressing LVOTO-related anatomical concerns. The company is positioning the Clarity Valve as an evolution of its TMVR platform while maintaining the established transfemoral approach. However, the announcement describes these findings as clinical experience rather than definitive evidence of comparative superiority, making continued evidence generation important as the device moves into broader clinical use.

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Four-Year Platform Data and U.S. Trial Ahead

The Clarity Valve also builds on longer-term clinical experience with the broader HighLife TMVR System. Four-year follow-up from the first 35 consecutively treated patients demonstrated sustained reduction in mitral regurgitation and stable mean valve gradients. The company reported a 4-year mean valve gradient of 4.7 mmHg, along with no reported clinical valve thrombosis, LVOT obstruction, hemolysis or percutaneous paravalvular leak closure in that dataset. HighLife said the four-year data also showed limited incremental heart-failure hospitalizations between years two and four, with no increase in conversion to surgery or reintervention after the first year. The Clarity Valve is planned as the study device for HighLife’s U.S. pivotal trial, which the company expects to begin enrolling and treating patients in the third quarter of 2026. The new CE Mark approval enables a limited commercial introduction in selected European regions, while the HighLife TMVR System and Clarity Valve remain investigational and not approved for commercial sale in the United States.

Source: HighLife press release