CroíValve Announces First Implant of a Novel Minimally Invasive Device for Tricuspid Regurgitation in US Early Feasibility Study

CroíValve, a pioneering medical device company focused on the development of a novel transcatheter device for the treatment of severe+ tricuspid regurgitation (TR), announced the first patient treated with the DUO™ System as part of the TANDEM II Early Feasibility Study in the U.S. The DUO™ System is a transcatheter valve that works in tandem with the native tricuspid valve to restore valve function while preserving the native valve apparatus.

The TANDEM II Study is a prospective, multicenter study in the US to evaluate the safety and performance of the DUO™ System in patients with severe+ symptomatic tricuspid regurgitation, a severe heart condition that occurs when the tricuspid valve in the right side of the heart fails to close properly. This results in blood being pumped backwards into the right atrium and venous system causing debilitating symptoms. It affects over 1.6 million people in the U.S. and is associated with significant morbidity and reduced life expectancy.

The first implant was performed by interventional cardiologists Pradeep Yadav, MD and James Stewart, MD and cardiac surgeon Vinod H. Thourani MD, the Principal Investigator for the TANDEM II study, at Piedmont Heart Institute in Atlanta, GA. “The DUO™ System offers a unique benefit for patients suffering from TR as the device is designed to treat a broad patient population. The DUO™ procedure is straightforward, leveraging standard interventional techniques and has the potential to accelerate transcatheter tricuspid therapy adoption by more physicians due to the system’s simplicity and scalability. This is a limitation with many other devices. On behalf of the TANDEM II investigators, we look forward to advancing treatment options for patients suffering from tricuspid regurgitation,” said Dr. Thourani, MD, the Bernie Marcus Chairman, Department of Cardiovascular Surgery and Marcus Valve Center at Piedmont Heart Institute.

“Every patient has a unique tricuspid valve anatomy and disease etiology which can make device procedures complex. The DUO™ System is an important option in my treatment toolbox,” said Dr. Yadav, Director of Structural Heart Interventions at Piedmont Heart Institute.

The DUO™ System preserves native right heart anatomy, combining two powerful capabilities –simplification and scalability– to enable more physicians to improve patients’ lives.

The DUO™ System includes a coaptation valve, an adjustable catheter system and a stent for anchoring. The coaptation valve is positioned between the native tricuspid leaflets to fill the leaky area and prevent regurgitation. A novel anchor system leaves the right heart and native valve apparatus untouched. The DUO™ implant procedure uses standard imaging and is less reliant on expert intraprocedural imaging, enabling a scalable procedure for broad therapy adoption.

“We are excited to work with the leading heart valve centers in the U.S. 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,” said Lucy O’Keeffe, CEO of CroíValve.

About CroíValve

CroíValve is a clinical stage medical device company focused on the development of a novel transcatheter device for the treatment of tricuspid regurgitation with Research, Development and Operations based in Ireland and Clinical, Regulatory and Marketing based in the United States.

Caution: The DUO™ System is an investigational device and not for sale in any geography.