CroiValve Introduces First Implant of Minimally Invasive Device for Tricuspid Regurgitation

CroíValve, specialising in the development of transcatheter solutions, has announced the first patient treatment using its DUO™ System in the TANDEM II Early Feasibility Study in the United States.

The DUO™ System is designed to work alongside the native tricuspid valve, restoring functionality without altering the natural valve structure. It addresses severe+ tricuspid regurgitation (TR), a condition where the tricuspid valve does not close properly, causing blood to flow backwards into the right atrium and venous system.

The TANDEM II study is a prospective, multicentre trial aimed at assessing the safety and performance of the DUO™ System in patients with severe+ symptomatic TR.

The first implantation was successfully carried out at Piedmont Heart Institute in Atlanta, Georgia, by a team comprising interventional cardiologists and cardiac surgeons. The procedure highlights the DUO™ System’s potential to simplify treatment for a broad patient population. The straightforward approach leverages standard interventional techniques, which could accelerate adoption among physicians.

The DUO™ System incorporates three key components: a coaptation valve, an adjustable catheter system, and an anchoring stent. The coaptation valve is positioned between the native tricuspid leaflets to close the leaking area and prevent blood regurgitation.

The unique anchoring system preserves the anatomy of the right heart and the native valve apparatus, while the procedure relies on standard imaging techniques, making it more accessible and scalable.

This system provides a valuable option for treating the diverse anatomical and disease profiles associated with TR. By maintaining the native structure of the heart, the device combines simplicity with scalability, enabling broader adoption and improved patient outcomes.

The initiation of the TANDEM II Early Feasibility Study marks a significant step in generating clinical evidence to support the DUO™ System’s use.

Source: https://www.businesswire.com/news/home/20241024551125/en/Cro%C3%ADValve-Announces-First-Implant-of-a-Novel-Minimally-Invasive-Device-for-Tricuspid-Regurgitation-in-US-Early-Feasibility-Study