CroíValve’s DUO System Shows Promise in Treating Tricuspid Regurgitation

CroíValve is sharing favorable patient outcomes from a study of its device for tricuspid regurgitation (TR) treatment.

The company’s DUO System is a transcatheter coaptation valve that works in tandem with the native tricuspid valve to restore valve function, using an anchor system that leaves the right heart and native valve apparatus untouched.

“The six-month results with the DUO System are highly promising, not only for its clinical safety and efficacy, but also for the procedure’s simplicity and the technology’s broad applicability,” stated Professor Wojtek Wojakowski, chief, Division of Cardiology and Structural Heart Diseases at the Medical University of Silesia in Poland. “This system offers new hope for patients suffering from severe TR, providing a versatile and predictable treatment option that simplifies the procedural and imaging experience for operators.”

Following 30-day outcomes presented last year, the six-month results demonstrated significant TR reduction by an independent core lab assessment, with TR reduced to moderate or less in more than 85% of patients, even with massive or torrential TR at baseline. Patients also experienced markedly improved functional and Quality of Life outcomes, with a notable significant increase in both KCCQ score and 6MWT over baseline. The trial reported a 100% survival rate at six months. No incidences of arrhythmia or conduction disorder requiring permanent pacing were reported, demonstrating the advantages of avoiding right heart contact. Additionally, this data shows stable long-term device positioning and function, while supporting natural reverse remodeling. The simplified procedural experience was highlighted by an average device time of 43 minutes, even with first use cases.

The DUO System is delivered using percutaneous techniques and is secured using a novel anchor system which leaves the right heart and native valve apparatus untouched. The implant procedure is straightforward, uses standard imaging and is suitable for a broad patient cohort as it is independent of annular diameter, coaptation gap, leaflet morphology and visibility.

“We are encouraged by these data, which demonstrate the DUO’s success in reducing TR and improving patients’ Quality of Life,” CroíValve Chief Medical Officer Dr. Martin Quinn stated. “Our goal is to expand the reach of treatment option for patients with tricuspid valve disease. We are committed to building strong evidence to support emerging therapies like the DUO System, with further clinical studies and patient follow-ups underway.”

CroíValve is an Irish clinical stage medical device company developing a transcatheter device for treating tricuspid regurgitation, with R&D and operations based in Dublin and clinical and regulatory activities based in the United States. The DUO System is an investigational device and not for sale in any geography.