HighLife TMVR System Receives CE Mark Approval

January 26, 2026–HighLife SAS, a France-based developer of transcatheter solutions for structural heart disease, announced that it has received CE Mark approval for the HighLife transcatheter mitral valve replacement (TMVR) system.

According to the company, the device is approved for the treatment of adult patients with symptomatic moderate-severe or severe mitral valve regurgitation, who are deemed unsuitable for surgical repair/replacement and transcatheter edge-to-edge repair by a multidisciplinary heart team.

The company advised it will begin a phased commercial introduction across Europe and will work with experienced structural heart centers to support initial cases, physician training, and postmarket clinical follow-up.

The HighLife TMVR features a dual-component valve-in-ring design, capable of treating a range of native mitral annulus sizes of 30–53 mm.

As outlined in the company’s press release, clinical experience with the HighLife TMVR system includes patients treated across multiple countries with longer-term follow-up data including the following:

• Sustained reduction of mitral regurgitation to mild or less
• Durable annular sealing enabled by HighLife’s subannular ring fixation design, with no reported peri- or postprocedural paravalvular aortic leak closure
• No reported cases of clinically significant hemolysis or clinical valve thrombosis
• No reported cases of left ventricular outflow tract obstruction
• Evidence of left ventricular reverse remodeling
• Improvements in New York Heart Association functional status and quality of life, including clinically meaningful changes in Kansas City Cardiomyopathy Questionnaire and 6-minute walk test

“Long-term durability data in TMVR are extremely limited, which is why the HighLife clinical experience is particularly meaningful,” commented Professor Wolfgang Rottbauer, MD, in the press release. “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.”

Professor Michael Joner, MD, added, “HighLife offers a procedural approach that feels familiar to interventional teams. 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.”