HighLife SAS, a company specializing in transcatheter solutions for structural heart disease, has earned CE mark approval for its HighLife transcatheter mitral valve replacement (TMVR) system.

The HighLife TMVR is meant to treat adult patients with symptomatic moderate-severe or severe mitral valve regurgitation (MR), who are deemed unsuitable for surgical repair/replacement and transcatheter edge-to-edge repair by a multi-disciplinary heart team.

The transfemoral mitral valve replacement option features a dual-component valve-in-ring design. According to the company, it can treat the broadest range of native mitral annulus sizes (30-53 mm) of any CE mark-approved TMVR system.

Long-term follow-up data showed durable outcomes, with sustained reduction of mitral regurgitation to mild or less. Durable annular sealing was enabled by HighLife’s sub-annular ring fixation design, with no reported peri- or post-procedural PVL closure. There were no reported cases of clinically significant hemolysis or clinical valve thrombosis.

There were also no reported cases of left ventricular outflow tract obstruction (LVOTO), and evidence of left ventricular reverse modeling—improvements in NYHA functional status and quality of life.

“Long-term durability data in TMVR are extremely limited, which is why the HighLife clinical experience is particularly meaningful,” said Professor Wolfgang Rottbauer, Universitätsklinikum Ulm. “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.”

Now that it has CE mark approval, the company will start a phased commercial introduction in Europe. It will work with experience structural heart centers 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, CEO 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 centers to ensure high-quality outcomes.”

In April 2025, the company received breakthrough status from the U.S. Food and Drug Administration (FDA) for its novel trans-septal mitral valve replacement (TSMVR) system for moderate to severe mitral regurgitation.