Cardiovalve Completes Enrollment for CE Registration of TTVR System

Cardiovalve Reaches Milestone in Regulatory Approval Journey

In a significant development for minimally invasive heart surgery, Venus Medtech (Hangzhou) Inc. has successfully completed patient enrollment for the TARGET study concerning its innovative Transcatheter Tricuspid Valve Replacement (TTVR) system. This study, a vital step for obtaining European CE Mark approval, has enrolled a total of 150 patients with tricuspid regurgitation, paving the way for its anticipated market entry in 2027.

The successful completion of the TARGET study enrollment marks a crucial milestone for Cardiovalve, the company’s flagship technology aimed at transforming how tricuspid valve-related heart conditions are treated. The ongoing commitment to pushing the boundaries of cardiovascular treatment is evident in Venus Medtech's rigorous clinical approach and the promising results anticipated from the trial.

With the TARGET study now concluded, Cardiovalve is gearing up to submit its CE Mark application to European regulators by the end of this year. This pivotal application will detail the results from the study, aiming to showcase the effectiveness and safety of the TTVR system in patients, thus helping to secure regulatory approval.

Pending CE Mark approval, Cardiovalve plans to commercially launch its TTVR system in Europe, expected in 2027. This anticipated product release follows a series of comprehensive clinical trials that underscore the company's dedication to enhancing patient outcomes without resorting to open-heart surgery. The introduction of Cardiovalve’s TTVR solution is expected to make significant strides in addressing the needs of patients suffering from tricuspid regurgitation, a condition that often leads to heart failure and has previously lacked effective treatment options.

In addition to the advancements with the TTVR system, Cardiovalve is also set to kick off its AHEAD study. This new trial will assess the safety and performance of the Cardiovalve's mitral valve replacement system for patients with significant mitral regurgitation. Results from the AHEAD study are intended to support a future CE Mark application for the mitral system, further bolstering the company’s innovative portfolio in transcatheter valve technologies.

A highlight of Cardiovalve's efforts will be its participation at the upcoming TCT 2025 conference, where preliminary data regarding the mitral regurgitation system will be presented. Dr. Christian Frerker will lead this presentation, titled "Transcatheter Mitral Valve Replacement Using the New Generation Cardiovalve System." Set for October 28, 2025, the session will provide an in-depth look at the cutting-edge technology being developed by the company.

Cardiovalve, as a subsidiary of Venus Medtech, is notable for its robust portfolio of patented technologies aimed at improving structural heart therapy. With over 150 approved patents and a state-of-the-art manufacturing facility, Cardiovalve is steadfast in its mission to deliver innovative solutions that enhance patient care and outcomes. Its dedication to research and development spans across various heart valve solutions, including TAVR (Transcatheter Aortic Valve Replacement), TPVR (Transcatheter Pulmonary Valve Replacement), and TMVR (Transcatheter Mitral Valve Replacement), ensuring that they are equipped to tackle complex cardiac issues head-on.

Looking ahead, Venus Medtech is committed to further pioneering advancements in minimally invasive cardiac interventions, with RD centers established globally in China, the United States, and Israel. By continuing to innovate and develop next-generation solutions, the company strives to provide effective treatments for life-threatening heart conditions, reiterating its position as a leader in the transcatheter heart valve space.

As Cardiovalve approaches the pivotal steps towards becoming a market-ready solution, the heart care landscape may be transformed, enabling better patient care and improved quality of life for those suffering from heart valve diseases.