Sam Brusco, Associate Editor01.25.24
CroíValve, an Irish-U.S. based company with a novel transcatheter solution for tricuspid regurgitation, has begun its TANDEM II early feasibility study (EFS) for the DUO tricuspid coaptation valve system. This follows U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) and CMS approval.
DUO is comprised of a coaptation valve that works with the native tricuspid valve to restore function. It’s delivered via a percutaneous approach and secured by a novel anchor system to leave the right heart and native valve apparatus untouched, according to the company.
Europe’s first-in-human TANDEM I trial demonstrated strong symptomatic improvement among a pool of highly symptomatic tricuspid regurgitation (TR) patients with a broad range of anatomies. CroíValve said those cases also showed the procedure is quick to learn and perform, and doesn’t need complex imaging.
The TANDEM II prospective, multi-center, non-randomized single-arm trial will assess DUO’s safety and performance for severe or greater symptomatic TR.
"We are delighted to initiate TANDEM II, with strong interest in participation in the study from leading U.S. centers. This marks a significant step forward in our efforts to continue generating clinical evidence demonstrating the safety and effectiveness of DUO,” said CroíValve CEO Lucy O’Keeffe. “We are confident it has the potential to revolutionize the standard of care by redefining how TR is treated, and ultimately enhancing the lives of patients in need."
DUO is comprised of a coaptation valve that works with the native tricuspid valve to restore function. It’s delivered via a percutaneous approach and secured by a novel anchor system to leave the right heart and native valve apparatus untouched, according to the company.
Europe’s first-in-human TANDEM I trial demonstrated strong symptomatic improvement among a pool of highly symptomatic tricuspid regurgitation (TR) patients with a broad range of anatomies. CroíValve said those cases also showed the procedure is quick to learn and perform, and doesn’t need complex imaging.
The TANDEM II prospective, multi-center, non-randomized single-arm trial will assess DUO’s safety and performance for severe or greater symptomatic TR.
"We are delighted to initiate TANDEM II, with strong interest in participation in the study from leading U.S. centers. This marks a significant step forward in our efforts to continue generating clinical evidence demonstrating the safety and effectiveness of DUO,” said CroíValve CEO Lucy O’Keeffe. “We are confident it has the potential to revolutionize the standard of care by redefining how TR is treated, and ultimately enhancing the lives of patients in need."