HighLife SAS has announced that it has received CE mark approval for the HighLife transcatheter mitral valve replacement (TMVR) system for the treatment of adult patients suffering from symptomatic moderate-severe or severe mitral regurgitation (MR), who are deemed unsuitable for surgical repair or replacement and transcatheter edge-to-edge repair (TEER) by a multidisciplinary heart team.
The initial commercial availability of the HighLife TMVR system across Europe provides access to a transfemoral mitral valve replacement option featuring a dual-component valve-in-ring design, capable of treating the broadest range of native mitral annulus sizes (30–53mm) of any CE mark–approved TMVR system.
Clinical experience with the HighLife TMVR system includes patients treated across multiple countries, with longer-term follow-up data demonstrating durable outcomes, including sustained reduction of mitral regurgitation to mild or less; durable annular sealing enabled by a sub-annular ring fixation design, with no reported peri- or post-procedural paravalvular leakage PVL closure.
No cases of clinically significant haemolysis or clinical valve thrombosis have been reported, and there have been no reported cases of left ventricular outflow tract obstruction (LVOTO).
Early cases have demonstrated evidence of left ventricular reverse remodelling and improvements in New York Heart Association (NYHA) functional status and quality of life, including clinically meaningful changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) and six-minute walk test (6MWT) scores.
“Long-term durability data in TMVR are extremely limited, which is why the HighLife clinical experience is particularly meaningful,” said Wolfgang Rottbauer (Universitätsklinikum Ulm, Ulm, Germany). “The system has demonstrated stable performance over multiple years, together with a transfemoral approach and predictable valve function, offering physicians an important new option for patients with severe mitral regurgitation who are not candidates for surgery or repair.”
In a press release issued by the company to announce the milestone, HighLife said it has placed a strong emphasis on procedural reproducibility and imaging-based follow-up to support safe and consistent adoption as the therapy transitions into early commercial use, “reinforcing confidence in real-world clinical practice”.
“HighLife offers a procedural approach that feels familiar to interventional teams,” said Michael Joner (Deutsches Herzzentrum München, Munich, Germany). “The two-step process of ring implantation followed by valve deployment is straightforward and reproducible, fits naturally into the cath-lab environment, and can be performed within procedure times similar to those of transcatheter edge-to-edge repair.”
With CE Mark approval, HighLife will begin a phased commercial introduction across Europe, working closely with experienced structural heart centres to support initial cases, physician training, and post-market clinical follow-up.
“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,” said Stefan Pilz, chief executive officer of HighLife. “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.”
The company plans to continue expanding its clinical evidence base, including longer-term durability follow-up.
