Dr. Marek Grygier posted on LinkedIn that the first procedure took place at Poznan University Hospital in Poland. Grygier performed the procedure alongside Dr. Stebastian Stefaniak. Dr. Agata Markiewicz provided cardiographic guidance, while Dr. Marcin Ligowski delivered anesthesiology support. The procedure also had on-site support from CroíValve specialists.
“This week at Poznan University Hospital, within the TANDEM II clinical study, we performed the world’s first transcatheter treatment of tricuspid regurgitation using the CroiValve Duo Adapt system,” Grygier posted. He called it “a meaningful step forward in the field of structural heart interventions.”
TANDEM II evaluates Duo in the treatment of severe tricuspid regurgitation (TR). Duo works in tandem with the native tricuspid valve to restore valve function. Delivered using percutaneous techniques, Duo is anchored in a novel way. A support catheter anchored to a stent in the superior vena cava secures the valve across the annulus. This anchor system leaves the right heart and native valve apparatus untouched.
The system won FDA investigational device exemption in early 2024 and kicked off an early feasibility study in the U.S. in October 2024. Duo could enter the hot tricuspid repair space that features Edwards’ Evoque and Abbott’s TriClip systems. CroíValve CEO Lucy O’Keeffe outlined the company’s mission in an interview with MassDevice last year.
“We are delighted by the spectacular echocardiographic effect of the procedure,” Grygier wrote. “We believe this technology will expand treatment options for patients with severe tricuspid regurgitation, especially those who are not candidates for T-TEER procedures or Evoque valve implantation.”
CroíValve is one of many up-and-coming medtech companies out of Ireland. Learn more about the country’s growing medtech ecosystem here.
