Cardiovalve Achieves Key CE Submission After Successful TARGET Study Results

Cardiovalve Submits CE File for Approval Following TARGET Study

Venus Medtech (Hangzhou) Inc. announced that its subsidiary, Cardiovalve, has submitted the CE technical file for its transcatheter tricuspid valve replacement (TTVR) system. This significant development comes on the heels of the successful completion of the TARGET study, which enrolled 150 patients across multiple centers in Europe, the UK, and Canada. The primary goal of the TARGET study was to evaluate the safety and performance of the Cardiovalve system in real-world clinical scenarios.

During the recent PCR London Valves 2025 conference, Prof. Georg Nickenig presented the interim results of the TARGET study, highlighting that the Cardiovalve system effectively eliminated tricuspid regurgitation (TR) in most patients, even among those with severe initial conditions. This compelling data underscores the potential of this innovative approach in treating heart valve disorders that have traditionally posed serious challenges for patients. In fact, 73% of the subjects had massive or torrential TR at baseline yet demonstrated significant improvements following the procedure.

Notably, the interim results published on November 16, 2025, indicated that 30 days post-treatment, patients experienced marked relief from symptoms, presenting a promising safety profile for the procedure. This is a pivotal aspect of any new medical solution, as effective treatment must go hand-in-hand with patient safety. The comprehensive study will follow these patients for up to five years to assess long-term outcomes, including mortality rates and heart failure hospitalizations, providing further insights into the efficacy and longevity of the results.

The interim findings reflect the commitment of the research and clinical teams involved, with Prof. Georg Nickenig emphasizing the strong efficacy of the Cardiovalve system in reducing TR. He expressed optimism about the potential impact these results could have, stating, "These findings represent a significant leap forward, giving hope to patients burdened by TR who may soon benefit from a new and effective treatment option."

Highlighting the importance of this CE submission, Amir Gross, CEO of Cardiovalve, remarked, "Submitting the CE file symbolizes a crucial milestone as we aim to provide transformative therapies for patients grappling with severe mitral and tricuspid regurgitation. The collective efforts of our investigative teams, clinical partners, and the invaluable trust of patients and their families has made this achievement possible."

In conjunction with this, Lim Hou-Sen, CEO of Venus Medtech, praised the promising results from the study. He stated, "These advancements herald a bright future for patients with tricuspid regurgitation, and with our CE application presently under review, we are hopeful for a successful certification process soon, paving the way for a commercial rollout of the TR system by 2027."

Cardiovalve operates at the forefront of transcatheter valve replacement technology, committed to innovation in the field of structural heart therapies. With more than 150 patents approved, their cutting-edge solutions aim to enhance patient outcomes and quality of life without resorting to invasive open-heart surgery. As part of Venus Medtech, they have established themselves as leaders in developing comprehensive heart valve solutions aimed at addressing diverse cardiac conditions.

This submission to DEKRA, the notified body in charge of CE mark approval in Europe, signifies Cardiovalve's ambition to make their transformative technology accessible to healthcare providers and patients alike. If approved, the initiative could introduce a new paradigm in the management of tricuspid regurgitation, offering patients a less invasive and highly effective option, ultimately redefining treatment pathways for one of the most challenging cardiovascular conditions.

As the medical community awaits further findings from the full dataset, the implications of the TARGET study and the subsequent CE submission could very well reshape expectations surrounding the management of tricuspid valve diseases in patients around the globe.