HighLife’s TSMVR System Granted FDA Breakthrough Device Designation

April 7, 2025—HighLife SAS, a France-based developer of a transseptal mitral valve replacement (TSMVR) system to treat moderate to severe mitral regurgitation, announced that the United States FDA has granted Breakthrough Device designation for the system.

The company advised that the HighLife TSMVR technology is under investigation in clinical studies in Europe, the United States, and the Asia-Pacific region. Additionally, the company announced in June 2024 that it received approval for an investigational device exemption from the FDA to initiate a United States pivotal study of the TSMVR system.

As noted in HighLife’s press release, the FDA’s Breakthrough Device program is designed to accelerate the development and review of devices that offer substantial improvement over current treatments or diagnostics for serious conditions and address unmet medical needs. The designation provides companies with access to more frequent interactions with the FDA, facilitating a faster path to approval and the potential for earlier access to innovative medical devices for patients and health care providers.