HighLife’s innovative transcatheter mitral valve replacement system has secured CE Mark approval, enabling European commercialization for high-risk adult patients with symptomatic moderate-to-severe or severe mitral regurgitation unsuitable for surgery or edge-to-edge repair. The dual-component, transfemoral device delivers durable regurgitation reduction, reliable sealing, and meaningful functional improvements, addressing a significant unmet need in structural heart care.
HighLife TMVR System Achieves Landmark CE Mark Approval
HighLife SAS has obtained CE Mark certification for its Transcatheter Mitral Valve Replacement (TMVR) System, marking a pivotal advancement in minimally invasive therapies for mitral regurgitation (MR). The approval covers adult patients with symptomatic moderate-to-severe or severe MR who are deemed unsuitable for surgical mitral valve repair or replacement or transcatheter edge-to-edge repair techniques, following evaluation by a multidisciplinary heart team.
The HighLife TMVR System employs a dual-component valve-in-ring architecture delivered through a transfemoral access route. This configuration supports implantation across native mitral annulus diameters ranging from 30 mm to 53 mm, representing the widest treatment range among CE-marked TMVR technologies currently available. The sub-annular ring component anchors the device for secure fixation and annular sealing, while the valve component replaces the dysfunctional mitral valve leaflets.
Clinical evidence accumulated from patients treated across various European centers underscores the system’s performance. Follow-up data reveal consistent and sustained reduction of mitral regurgitation to mild or less severity. Annular sealing has proven robust, with no instances of peri-procedural or post-procedural paravalvular leaks requiring additional intervention. Importantly, no clinically significant hemolysis, clinical valve thrombosis, or left ventricular outflow tract obstruction has been observed.
Beyond regurgitation control, patients exhibit positive cardiac remodeling, including left ventricular reverse remodeling that contributes to improved overall heart function. Functional status has advanced, as evidenced by shifts to better New York Heart Association (NYHA) classifications. Quality-of-life measures, assessed through the Kansas City Cardiomyopathy Questionnaire (KCCQ), show clinically meaningful gains, and exercise capacity has increased according to six-minute walk test (6MWT) results.
Interventional cardiologists familiar with the technology have noted its procedural advantages. The two-step implantation sequence—first deploying the sub-annular ring, then positioning the valve—aligns well with standard cath lab practices. The approach is described as reproducible and efficient, with procedure durations often comparable to those of established transcatheter edge-to-edge repair methods. The transfemoral route minimizes invasiveness compared to transapical or transseptal alternatives in some competing systems.
HighLife intends to initiate a controlled commercial rollout across Europe. The company will collaborate closely with select high-volume structural heart programs to conduct initial procedures, deliver specialized physician training, and establish rigorous post-market clinical monitoring. This phased strategy prioritizes procedural consistency, imaging-guided follow-up, and the collection of real-world evidence to support broader adoption.
The approval arrives amid strong momentum in the transcatheter mitral valve intervention sector. An aging population, rising MR prevalence, and demand for lower-risk alternatives to open-heart surgery are fueling expansion. Industry projections indicate the broader transcatheter mitral valve device market could grow substantially in the coming years, with compound annual growth rates exceeding 20% in some estimates. While several established players dominate related segments, HighLife’s entry with a broad-annulus, durable TMVR option differentiates it for patients previously left without viable treatments. In Europe alone, hundreds of thousands of MR patients annually go without surgical or transcatheter repair, highlighting the clinical and economic burden this technology aims to alleviate.
The CE Mark applies exclusively to Europe; the system remains investigational in the United States, where an investigational device exemption supports ongoing pivotal trials.
Key System Specifications
Delivery method: Transfemoral
Design: Dual-component valve-in-ring
Annulus compatibility: 30–53 mm
Fixation mechanism: Sub-annular ring for durable sealing
Access profile: Minimally invasive, no transapical requirement
Observed Clinical Outcomes
Mitral regurgitation: Sustained reduction to mild or less
Paravalvular leak: None requiring closure
Adverse events: No significant hemolysis, valve thrombosis, or LVOTO
Remodeling: Left ventricular reverse remodeling documented
Functional gains: Improved NYHA class, KCCQ scores, and 6MWT distances
Disclaimer: This is a news report based on publicly available information and is provided for informational purposes only. It does not constitute medical advice, investment recommendation, or financial guidance.
