CroíValve Begins TANDEM II Early Feasibility Study for Duo System to Treat TR

October 24, 2024—CroíValve announced the first patient treated with the Duo system as part of the TANDEM II early feasibility study in the United States. The prospective, multicenter study will evaluate the safety and performance of the Duo system in patients with severe symptomatic tricuspid regurgitation (TR).

According to the company, 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 Duo system is an investigational device and not for sale in any geography advised CroíValve.

The company reported that the first implantation in the study was performed by interventional cardiologists Pradeep Yadav, MD, and James Stewart, MD, and cardiac surgeon Vinod H. Thourani, MD, at Piedmont Heart Institute in Atlanta, Georgia.

Dr. Thourani serves as the Principal Investigator for the TANDEM II study. He is the Bernie Marcus Chairman, Department of Cardiovascular Surgery and Marcus Valve Center at Piedmont Heart Institute.

“The Duo system offers a unique benefit for patients suffering from TR as the device is designed to treat a broad patient population,” commented Dr. Thourani in CroíValve’s press release. “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.”

Dr. Thourani added, “On behalf of the TANDEM II investigators, we look forward to advancing treatment options for patients suffering from TR.”

Dr. Yadav, who is Director of Structural Heart Interventions at Piedmont Heart Institute, stated in the press release, “Every patient has a unique tricuspid valve anatomy and disease etiology which can make device procedures complex. The Duo system is an important option in my treatment toolbox.”