Cardiovalve has announced the successful completion of patient enrollment in its TARGET study, which focuses on the transcatheter tricuspid valve replacement (TTVR). The company has enrolled a total of 150 patients, marking a significant milestone in its efforts to secure European regulatory approval for its TTVR system, aimed at treating tricuspid regurgitation.
The completion of patient recruitment positions Cardiovalve to submit its application for the CE mark to European regulatory authorities by the end of this year. Pending approval, the commercial launch of the Cardiovalve TTVR system is anticipated in 2027.
Building on this achievement, Cardiovalve is also preparing to initiate its AHEAD study. This forthcoming research will assess the safety and efficacy of its mitral valve replacement system in patients with significant mitral regurgitation, further supporting future CE mark applications for the mitral system.
In addition, Cardiovalve is set to present preliminary data on its mitral regurgitation system at the upcoming TCT 2025 conference. The session, titled “Transcatheter Mitral Valve Replacement Using the Next-Generation Cardiovalve System,” will be led by Dr. Christian Frerker.
Cardiovalve, a subsidiary of Venus Medtech, is at the forefront of transcatheter valve replacement technology, driving innovation in structural heart therapies. With over 150 patents granted and a highly experienced team, the company is committed to providing cutting-edge solutions that enhance patient outcomes and quality of life, all while avoiding the need for open-heart surgery.
Venus Medtech (Hangzhou) Inc. is recognized as a leader in innovative transcatheter heart valve solutions for structural heart diseases. The company has developed a comprehensive product line covering all four heart valves (TAVR, TPVR, TMVR, and TTVR) along with their accessories. With global research and development centers located in China, the United States, and Israel, Venus Medtech is dedicated to delivering effective therapeutic solutions for potentially life-threatening conditions.
