HighLife has received CE mark approval for its transcatheter mitral valve replacement (TMVR) system, allowing commercialisation across Europe for adult patients with symptomatic moderate-severe or severe mitral regurgitation (MR) unsuitable for surgery or edge-to-edge repair.
The approval gives HighLife access to the European market, offering a transfemoral valve replacement option with a dual-component valve-in-ring design.
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The system is indicated for a wide range of native mitral annulus sizes (30mm–53mm), currently the broadest among CE-marked TMVR systems in Europe.
Clinical experience so far covers multiple countries, with extended follow-up data indicating that mitral regurgitation remains consistently reduced to mild or less.
Additional outcomes include lasting annular sealing achieved by the sub-annular ring fixation design and an absence of peri- or post-procedural paravalvular leak closure.
No incidences of clinically significant haemolysis, valve thrombosis, or left ventricular outflow tract obstruction (LVOTO) have been observed so far.
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By GlobalDataEvidence supports left ventricular reverse remodelling, improvements in New York Heart Association (NYHA) functional status and quality of life, with measurable changes in six-minute walk test (6MWT) and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores.
The company plans to prioritise procedural consistency and imaging-guided follow-up to help ensure safety as the technology is introduced in early commercial settings.
HighLife intends to collaborate closely with structural heart centres for the first cases, provide physician training, and gather post-market clinical data.
Plans include further expansion of clinical evidence through long-term durability monitoring.
HighLife CEO Stefan Pilz said: “CE Mark approval allows us to begin the next phase of HighLife’s journey—bringing a new transcatheter mitral valve replacement option to patients in Europe, particularly those with limited treatment options today.
“Each year, an estimated 300,000 patients in Europe with mitral regurgitation are not treated with heart surgery or transcatheter repair, and we are thrilled to offer this population a new treatment option. We are committed to a thoughtful commercial introduction, working closely with leading heart centres to ensure high-quality outcomes.”
In June 2024, the FDA granted an investigational device exemption (IDE) to HighLife, approving a pivotal trial investigating the company’s trans-septal mitral valve replacement (TSMVR) system.
