#China #Hangzhou #Venus Medtech #Cardiovalve #TARGET Study

Cardiovalve Advances in Heart Valve Technology

Venus Medtech (Hangzhou) Inc., a key player in the field of transcatheter heart valve technology, has recently made notable strides by submitting the CE technical file for its transcatheter tricuspid valve replacement (TTVR) system. This significant milestone follows the successful completion of the TARGET study, which highlighted the system's effectiveness in treating tricuspid regurgitation (TR).

Overview of the TARGET Study

The TARGET study presented valuable insights during its interim analysis at the prominent PCR London Valves 2025 meeting. Conducted across 30 sites in Europe, the UK, and Canada, this multicenter trial involved 150 patients and was designed to assess the safety and performance of the Cardiovalve system. Notably, results indicated a remarkable elimination of TR in most patients, with 73% experiencing severe TR at the onset of the study. This speaks volumes about the clinical effectiveness of the Cardiovalve device in patients who previously had limited treatment options.

Key Findings from the Study

As outlined by the Principal Investigator Professor Georg Nickenig, the interim results showcased not only the procedure's efficacy but also reflected an acceptable safety profile, with significant relief in patient symptoms observed by the end of the 30-day postoperative period. The ongoing follow-up on these selected patients will continue for up to five years, promising comprehensive clinical outcomes. Future reports will include crucial data concerning mortality rates and hospitalizations due to heart failure, strengthening the body of evidence supporting the Cardiovalve system.

Perspective from Company Leaders

Amir Gross, CEO of Cardiovalve, emphasized that: "The submission of the CE file marks a pivotal milestone and brings Cardiovalve closer to delivering transformative therapy for patients suffering from severe mitral and tricuspid regurgitation." He attributed this achievement to the dedicated efforts of the team's shared vision and commitment. Likewise, Lim Hou-Sen, CEO of Venus Medtech, noted, "These promising results mark a significant advancement for patients suffering from tricuspid regurgitation."

Looking Forward

Cardiovalve, a subsidiary of Venus Medtech, holds a pioneering position within the transcatheter valve replacement technology domain. Backed by over 150 approved patents and a highly experienced team, the company continues to innovate solutions aimed at improving patient outcomes and quality of life—all without the necessity for open-heart surgery. With global research and development centers spanning China, the U.S., and Israel, Venus Medtech is poised to provide advanced treatment solutions for structural heart diseases globally.

The upcoming months will be crucial for Cardiovalve as it awaits CE mark certification, with hopes of beginning the commercial rollout of the TR system by 2027. The promising outcomes of the TARGET study coupled with the company's commitment to innovation set the stage for a new chapter in heart valve solutions, paving the way for improved treatment options for patients plagued by tricuspid regurgitation and beyond.