CroíValve, a medical device company specialising in developing transcatheter devices for severe tricuspid regurgitation (TR) treatment, has announced the first patient implantation of its DUO System.
This procedure was conducted as part of the TANDEM II Early Feasibility Study in the US.
The DUO System is a transcatheter valve designed to function alongside the native tricuspid valve, enhancing its performance while preserving the native valve structure.
The TANDEM II Study is a prospective, multicentre trial in the US aimed at assessing the safety and efficacy of the DUO System in patients suffering from severe symptomatic tricuspid regurgitation.
TR is a serious heart condition that occurs when the tricuspid valve on the heart’s right side fails to close properly, causing blood to flow backwards into the right atrium and venous system, leading to significant symptoms. The condition is linked to high rates of illness and a shorter life expectancy.
The maiden implant procedure of the DUO System was carried out by interventional cardiologists Pradeep Yadav and James Stewart, along with cardiac surgeon Vinod Thourani, the principal investigator for the TANDEM II study.
The procedure took place at Piedmont Heart Institute in Atlanta, Georgia.
The DUO System retains the native anatomy of the right heart, combining features that support both simplicity and scalability, allowing more healthcare providers to treat patients effectively. The system includes a coaptation valve, an adjustable catheter system, and a stent for anchorage.
The coaptation valve is positioned between the native tricuspid leaflets to fill the leaky area and prevent regurgitation. The anchor system is designed to leave the right heart and native valve apparatus intact.
According to CroíValve, the implantation procedure utilises standard imaging techniques and does not rely heavily on expert intraprocedural imaging, making it a scalable option that can be adopted widely for therapy.
CroíValve CEO Lucy O’Keeffe said: “We are excited to work with the leading heart valve centres in the US to offer more patients suffering from tricuspid regurgitation a treatment option. The initiation of the TANDEM II Early Feasibility Study is an important milestone as we expand the clinical evidence for the DUO System.”
In August 2024, CroíValve raised $16m in a Series B financing round, led by the MedTech & Irrus Syndicates.
