Venus Medtech’s Cardiovalve subsidiary announced today that it completed enrollment in a study of its transcatheter tricuspid valve replacement (TTVR) system.
The TARGET study evaluates the flagship Cardiovalve system that fits both mitral and tricuspid anatomies. Enrollment reached 150 patients, helping the company take the next steps toward regulatory approval for the TTVR system.
Cardiovalve designed its implant for transfemoral delivery to avoid the need for open-heart surgery. It features a short profile for minimal protrusion into the ventricles, a robust anchoring mechanism and an enhanced sealing solution to prevent paravalvular leaks.
With enrollment complete, the company said it has preparations underway to submit for CE mark later this year. It aims to garner approval and begin a European launch in 2027.
Next, the company plans to initiate the AHEAD study, evaluating the company’s mitral valve replacement system for mitral regurgitation (MR). It hopes for the study to support a CE mark application for that platform.
Additionally, Cardiovalve plans to present preliminary data for the mitral valve for MR at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. Dr. Christian Frerker will lead the presentation at TCT, titled “Transcatheter Mitral Valve Replacement Using the New Generation Cardiovalve System.”
