The submission of the transcatheter tricuspid valve replacement (TTVR) system follows the completion of the company’s TARGET study. TARGET enrolled 150 patients and demonstrated the safety and performance of the Cardiovalve system. The company completed enrollment last month.
Cardiovalve designed its implant, which fits both mitral and tricuspid anatomies, for transfemoral delivery. It aims to avoid the need for open-heart surgery. The system features a short profile for minimal protrusion into the ventricles, a robust anchoring mechanism and an enhanced sealing solution. This helps to prevent paravalvular leaks.
The company said last month that it aims to garner approval and begin a European launch in 2027. With the CE mark submission and positive TARGET results, Venus Medtech CEO Lim Hou-Sen said the company is “well-positioned to achieve certification and begin commercial rollout of the [tricuspid regurgitation] system by 2027.”
Interim TARGET results showed that the valve effectively eliminated tricuspid regurgitation (TR) in the majority of patients. This occurred despite 73% presenting with massive or torrential TR at baseline.
The procedure also demonstrated an acceptable safety profile. Investigators reported improvements in patient symptoms by 30 days post-treatment. They intend to follow patients for up to five years, with plans to present comprehensive outcomes, including mortality and heart failure hospitalizations from the full 150-patient cohort, in the near future.
“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,” said Amir Gross, CEO of Cardiovalve, “This achievement reflects the commitment of a focused team with a shared vision, a team that doesn’t just aim; it hits the target. Deep appreciation goes to the investigators, coordinators, clinical partners, and most importantly, the patients and their families for their trust.”
