Professor Wojciech Wojakowski presented data looking at Duo in the treatment of tricuspid regurgitation (TR) at New York Valves 2024.
Duo, a novel, transcatheter coaptation valve, works in tandem with the native tricuspid valve to restore valve function. Delivered using percutaneous techniques, Duo is anchored in a novel way — it is secured across the annulus by a support catheter anchored to a stent in the superior vena cava. This anchor system leaves the right heart and native valve apparatus untouched.
The system won FDA investigational device exemption at the start of the year and kicked off an early feasibility study for the Duo system. Duo could enter the hot tricuspid repair space that features Edwards’ Evoque and Abbott’s TriClip systems.(Read more about Duo’s unique approach at Medical Design & Outsourcing).
A look at the data presented by CroíValve
CroíValve’s TANDEM I trial evaluates Duo’s safety and performance in 10 patients and so far shows sustained positive outcomes. Six-month results presented today demonstrated significant TR reduction. TR fell to moderate or less in more than 85% of patients. This reduction occurred even with massive or torrential TR at baseline.
According to a news release, patients also experienced markedly improved quality of life outcomes. The trial reported a 100% survival rate at six months and no incidences of arrhythmia or conduction disorder requiring permanent pacing. Data also showed long-term device positioning and function while supporting natural reverse remodeling. Even in first-use cases, the study recorded an average device time of 43 minutes.
“We are encouraged by these data, which demonstrate the DUO’s success in reducing TR and improving patients’ Quality of Life,” said Dr Martin Quinn, chief medical officer of CroíValve. “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.”
