TMVR device with valve-in-ring design gains key approval
HighLife, a French medtech company founded in 2010, has gained CE mark approval for its flagship device, the HighLife Transcatheter Mitral Valve Replacement (TMVR) System. The approval covers the treatment of symptomatic moderate-severe or severe mitral valve regurgitation in patients who are seen as unsuitable for transcatheter edge-to-edge repair (TEER) or mitral valve surgery.
The HighLife TMVR System includes a valve-in-ring design that was built to treat patients with a wide variety of mitral annulus sizes. The ring is placed first, and then the valve centers itself inside that ring once it has been delivered. According to HighLife, this design was developed to achieve an efficient seal; the company aimed reduce the risk of paravalvular leak or any other post-implant complications.
Click here to read a full analysis of one-year outcomes associated with the HighLife TMVR System. Overall, the device was linked to a technical success rate of 90%. While 78% of patients had with no mitral regurgitation (MR) or trace MR one year after treatment, the other 22% had mild MR. The analysis was published in JACC: Cardiovascular Interventions in November 2023.[1]
“HighLife offers a procedural approach that feels familiar to interventional teams,” Professor Michael Joner, a cardiologist with the German Heart Centre Munich, said in a statement. “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 TEER.”
The HighLife TMVR System. Image courtesy of HighLife.
“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,” added Stefan Pilz, HighLife’s CEO. “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.”
The HighLife TMVR System should quickly be made commercially available throughout Europe. The device has not been approved by the U.S. Food and Drug Administration (FDA), so it is not yet available in the United States. However, it did receive the FDA’s breakthrough device designation in 2025, suggesting the agency sees potential in its ability to make an impact on patient care.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.