Croívalve Reports 1st Tricuspid Coaptation Valve Implant in U.S. Feasibility Study

CroíValve announced the first patient treated with its DUO system as part of its TANDEM II early feasibility study in the U.S. DUO is a transcatheter valve that works with the native tricuspid valve to restore valve function while preserving the native valve apparatus.
 
The TANDEM II Study is a prospective, multicenter U.S. study to evaluate the safety and performance of the DUO system in patients with severe+ symptomatic tricuspid regurgitation (TR), a severe heart condition that occurs when the tricuspid valve in the right side of the heart fails to close properly.
 
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.
 
DUO 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.
 
“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.