CroíValve has announced the first patient treated with the Duo system as part of the TANDEM II early feasibility study in the USA.
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, multicentre study in the USA to evaluate the safety and performance of the Duo system in patients with severe symptomatic tricuspid regurgitation (TR).
The first implant was performed by interventional cardiologists Pradeep Yadav and James Stewart, and cardiac surgeon Vinod Thourani ,the principal investigator for the TANDEM II study, at Piedmont Heart Institute in Atlanta, USA.
“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 Thourani, 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 aetiology which can make device procedures complex. The Duo system is an important option in my treatment toolbox,” said Yadav, director of structural heart interventions at Piedmont Heart Institute.
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 centres in the USA 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.
