CroíValve Begins TANDEM II Early Feasibility Study of Duo Tricuspid Coaptation Valve

January 25, 2024—CroíValve announced the initiation of its TANDEM II early feasibility study (EFS) for the Duo tricuspid coaptation valve system. The company, which is based in Ireland and the United States, has received FDA investigational device exemption and Centers for Medicare and Medicaid Services approvals to conduct the study.

CroíValve also announced it has appointed Martin B. Leon, MD, as Chair of its clinical advisory board.

According to CroíValve, the prospective, multicenter, nonrandomized, single-arm TANDEM II EFS will assess the safety and performance of the Duo device in patients with severe or greater symptomatic tricuspid regurgitation (TR).

The company noted that the European first-in-human TANDEM I trial showed strong symptomatic improvement in patients across all key measures. The treated population was highly symptomatic and represented the broad range of anatomies in TR patients. Additionally, these cases demonstrated that the procedure is quick to learn and perform, without the need for complex imaging.

The TANDEM II EFS will further develop the clinical validation of the Duo technology, stated CroíValve.

As described in the company’s press release, Duo consists of a coaptation valve that works in tandem with the native tricuspid valve to restore valve function. The device is delivered percutaneously and is secured using an anchor system that leaves the right heart and native valve apparatus untouched. The implant procedure uses standard imaging and is suitable for a broad patient cohort, accommodating the large anatomic variability seen in this patient population.

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

“I’m excited about the study bringing this uniquely designed device to patients in the United States and guiding it as Chair of the clinical advisory board,” commented Dr. Leon in CroíValve’s press release. “I believe the Duo system can simplify the treatment of TR patients, with a predictable procedure that can be performed with standard imaging techniques. Additionally, with minimal anatomic exclusions, it can reach a broad population. It has the potential to emerge as a meaningful advancement in the field of TR treatment.”

CroíValve stated that Dr. Leon is a pioneer in interventional cardiovascular medicine. Dr. Leon is the Mallah Family Professor of Cardiology at the Columbia University Irving Medical Center College of Physicians and Surgeons and Director of the Columbia Center for Interventional Care at New York-Presbyterian Hospital/Columbia University Medical Center in New York, New York. He also serves on the Executive Board of the New York-Presbyterian/Columbia Heart Valve Center. Dr. Leon is the Founder of TCT, the Transcatheter Cardiovascular Therapeutics symposium, and Chairman Emeritus of the Cardiovascular Research Foundation.