CroíValve Announces First-Ever Patient Enrolled in Global TANDEM II Study of Duo TTVR System for Tricuspid Regurgitation
CroíValve
Medical Device Developer
CroíValve Announces First Patient Treated with Duo System in U.S. TANDEM II Early Feasibility Study
The Duo system is a transcatheter valve that works in concert with the native tricuspid valve to restore valve function while preserving the native valve apparatus.
CroíValve DUO Tricuspid Valve Conformal Valve System is a novel approach that combines repair and replacement to provide the right solution for the right heart. The DUO system consists of two integrated components:
A docking valve, used to fill the regurgitant orifice and work in conjunction with the native valve. It comprises a docking body made of pericardial tissue and an artificial valve that supports diastolic blood flow.
Anchoring system connected to the docking valve, including a support catheter used to adjust and lock the position of the docking valve. It is fixed within the SVC via a stent. This approach allows for respiration and cardiac movement. The support catheter consists of a distal implantation segment and a proximal delivery segment, which is disconnected and removed at the end of the procedure.
TANDEM II Study is a prospective multicenter study conducted in the United States 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, along with cardiac surgeon Vinod Thourani, at the Piedmont Heart Institute in Atlanta, USA, the principal investigator of the TANDEM II study.
"The Duo system offers unique advantages for TR patients as it is designed to treat a wide range of patient populations. The Duo procedure is straightforward, utilizing standard interventional techniques, and due to the system's simplicity and scalability, it has the potential to accelerate the adoption of transcatheter tricuspid valve therapy by more physicians. This is a limitation of many other devices. On behalf of the TANDEM II researchers, we look forward to providing treatment options for patients with tricuspid regurgitation," said Bernie Marcus, Chairman of Cardiovascular Surgery at the Piedmont Heart Institute and the Marcus Valve Center.
"Each patient has a unique tricuspid valve anatomy and disease etiology, which can complicate device procedures. The Duo system is an important option in my treatment toolkit," said Yadav, Director of Structural Heart Interventions at the Piedmont Heart Institute.
The Duo system includes a docking valve, an adjustable catheter system, and a stent for anchoring. The docking valve is positioned between the native tricuspid valve leaflets to fill the leak area and prevent regurgitation.
A novel anchor system leaves the right heart and autologous valve organs unaffected. The Duo implantation procedure utilizes standard imaging, reducing reliance on expert intraoperative imaging, thus offering a scalable procedure for widespread therapeutic adoption.
"We are delighted to collaborate with leading heart valve centers in the U.S. to offer more treatment options for patients suffering from tricuspid regurgitation. The initiation of the TANDEM II Early Feasibility Study is a significant milestone as we continue to expand the clinical evidence for the Duo system," said Lucy O'Keeffe, CEO of CroíValve.
CroíValve is an early-stage medical device company dedicated to developing minimally invasive devices for the treatment of tricuspid regurgitation. Located in Dublin, Ireland, the company combines extensive clinical, technical, and commercial expertise, leveraging technology from the Trinity College Bioengineering Center. CroíValve is developing a minimally invasive device to treat "tricuspid regurgitation," which can be delivered via a vein to the right ventricle. The device fills the gap between the valve leaflets, thereby preventing regurgitation. This solution allows for rapid and cost-effective treatment without the need for prolonged hospitalization.