Venus Medtech has announced the submission of technical files for CE mark approval of the Cardiovalve transcatheter tricuspid valve replacement (TTVR) system, following completion of the TARGET study assessing the safety and performance of the device in 150 patients.
Taking place across 30 sites in Europe, the UK, and Canada the prospective, single-arm, open-label, multicentre clinical trial was designed to evaluate the safety and performance of the Cardiovalve tricuspid regurgitation (TR) system.
Interim results of the study were presented at PCR London Valves (16–18 November, London, UK), demonstrating that transcatheter tricuspid valve replacement (TTVR) with the Cardiovalve system effectively eliminated TR in the majority of patients, despite 73% presenting with massive or torrential TR at baseline, Venus Medtech detailed in a press release.
In addition to endpoints for efficacy, the procedure was observed to have an acceptable safety profile, with improvements in patients’ symptoms by 30 days post-treatment.
Patients enrolled in the study will continue to be followed for up to five years. Comprehensive clinical and echocardiographic outcomes, including mortality and heart failure hospitalisations from the full 150-patient cohort, will be presented in the near future.
George Nickenig (University Hospital Bonn, Bonn, Germany), who presented the results at PCR London Valves, was quoted in the press release as saying: “The results of the Cardiovalve study are highly encouraging, demonstrating strong efficacy in TR reduction and a favourable safety profile, particularly with the new device iteration. These findings represent an important step forward, offering hope that patients suffering from TR will soon have access to a novel and effective treatment option.”
“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.”
Lim Hou-Sen, chief executive officer of Venus Medtech, stated: “These promising results mark a significant advancement for patients suffering from tricuspid regurgitation. With the CE submission under review, Cardiovalve is well-positioned to achieve certification and begin commercial rollout of the TR system by 2027.”
