Cardiovalve Submits CE Approval Dossier Following TARGET Trial Success

In a major step towards advancing heart valve therapies, Cardiovalve, a subsidiary of Venus Medtech, has recently submitted its technical dossier for CE approval. This move follows the successful completion of the TARGET study, which presented significant findings regarding the safety and performance of the Cardiovalve tricuspid valve replacement system.

Overview of the TARGET Study

Conducted across 30 sites in Europe, the UK, and Canada, the TARGET study enrolled 150 patients to evaluate the effectiveness of the Cardiovalve system in treating tricuspid regurgitation (TR). The study was designed as an open-label, single-group, multicenter trial aimed at assessing not only the safety of the device but also its ability to significantly address TR experienced by participants. The most recent results were unveiled at the PCR London Valves 2025 meeting, showcasing compelling evidence of the system’s efficacy and safety.

The study revealed that the transcatheter tricuspid valve replacement (TTVR) procedure effectively eliminated TR among most participants, despite 73% of them initially presenting with massive or torrential regurgitation. Notably, an encouraging safety profile was also achieved, with most patients reporting symptom improvement within 30 days post-treatment.

Key Findings and Future Implications

Professor Georg Nickenig, who presented the study results, remarked on the encouraging nature of these findings, which demonstrate strong efficacy in reducing TR alongside a favorable safety profile. This represents a significant step forward for patients suffering from TR, who are in dire need of effective therapeutic options that do not require open-heart surgery.

According to Amir Gross, CEO of Cardiovalve, the submission for CE marking is a crucial milestone that paves the way for providing transformative therapy to patients suffering from severe tricuspid and mitral regurgitation. Gross emphasized that the success of this submission would reflect the dedication and shared vision of the research and clinical teams, expressing gratitude to all stakeholders involved—researchers, coordinators, clinical partners, and most importantly, the patients who participated in the study.

Lim Hou-Sen, CEO of Venus Medtech, also commented on the promising results, noting that with the CE submission currently under review, Cardiovalve is well-positioned to achieve certification and commence commercial rollout of the TR system by 2027. This timely advancement is anticipated to be a game-changer for many patients facing tricuspid regurgitation.

Conclusion

Cardiovalve stands at the forefront of innovation in transcatheter heart valve technology, with over 150 approved patents and a commitment to providing solutions that enhance patient outcomes and quality of life without the need for invasive surgical procedures. As they await CE approval, the promising outcomes from the TARGET study signify a new horizon in the treatment of structural heart diseases.

About Cardiovalve

Cardiovalve is a trailblazer in transcatheter heart valve replacement technologies. With an experienced team and cutting-edge manufacturing capabilities, Cardiovalve focuses on developing next-generation solutions for cardiac structural therapies, aiming to revolutionize the treatment landscape for heart conditions.

About Venus Medtech

Venus Medtech (Hangzhou) Inc. is a leading innovator in transcatheter heart valve solutions, focusing on structural heart disease. Through its expansive R&D efforts in China, the USA, and Israel, Venus Medtech is dedicated to advancing effective treatments for life-threatening conditions related to heart valve diseases.