#USA #London #Venus Medtech #Cardiovalve #TTVR

Overview of Cardiovalve's CE Submission

Venus Medtech (Hangzhou) Inc. has officially announced that Cardiovalve has submitted its CE technical file for approval to DEKRA, the notified body responsible for CE marking in Europe. This significant milestone follows the successful completion of the TARGET study, which involved 150 patients and demonstrated both the security and performance of the Cardiovalve system. The process signifies a hopeful step towards providing effective solutions for patients suffering from tricuspid regurgitation.

Insights into the TARGET Study

The results of the TARGET study were presented by Professor Georg Nickenig during a recent session at the PCR London Valves conference. This clinical trial was a prospective, single-arm, multicenter study designed to assess the safety and efficacy of the Cardiovalve transcatheter tricuspid valve replacement (TTVR) system. Conducted across 30 centers in Europe, the UK, and Canada, the study has been pivotal in affirming the device's clinical effectiveness in eliminating tricuspid regurgitation (TR) in a significant number of participants. Preliminary findings indicated that TTVR with the Cardiovalve system effectively resolved TR in most patients, even though 73% of them initially presented with severe TR.

Clinical Results and Patient Impact

The interim results published on November 16, 2025, showcased not only the high efficacy rates in TR reduction but also an acceptable safety profile associated with the procedure. Patients participating in the trial exhibited notable improvements in their symptoms by the 30-day follow-up post-treatment. The cohort will continue to be monitored for a maximum of five years, with comprehensive clinical and echocardiographic results—including mortality and heart failure hospitalizations—set to be released soon.

Professor Nickenig expressed optimism regarding the Cardiovalve outcomes, highlighting the clinical benefits of the device and its favorable safety profile, particularly with the new version of the system. His insights reveal the potential this technology holds for patients suffering from TR, emphasizing the urgency for innovative treatment options in this challenging area of cardiac health.

Acknowledgments and Future Prospects

Amir Gross, CEO of Cardiovalve, underscored the submission of the CE application as a crucial milestone that draws the company closer to offering transformative therapy for patients facing severe mitral and tricuspid insufficiencies. He acknowledged the commitment of their team, as well as the contributions of researchers, clinical partners, and patients in achieving this stage.

In alignment with this vision, Lim Hou-Sen, the CEO of Venus Medtech, remarked on the importance of the promising TARGET study results. He confidently noted that with the CE marking process underway, Cardiovalve is well-positioned to achieve certification and foreseeably commence commercial rollouts of the TTVR system by 2027.

About Cardiovalve and Venus Medtech

Cardiovalve, a subsidiary of Venus Medtech, is at the forefront of transcatheter valve replacement technology and is renowned for its innovative approaches in the treatment of structural heart diseases. Holding over 150 approved patents, the company prides itself on its experienced team and cutting-edge manufacturing capabilities, focusing on providing physicians with groundbreaking solutions that enhance patient outcomes and improve quality of life without invasive open-heart surgery. Venus Medtech (Hangzhou) Inc. continues to revolutionize the field of cardiac valve solutions, developing products across a spectrum of needs, including TAVR, TPVR, TMVR, and TTVR, reflecting its comprehensive commitment to addressing potentially life-threatening cardiac conditions.