The beginning of the study follows FDA investigational device (IDE) approval. Tandem II, a prospective, multi-center, non-randomized, single-arm study looks at the safety and performance of Duo in patients with severe or greater symptomatic tricuspid regurgitation (TR).
Duo features a coaptation valve that works in tandem with the native tricuspid valve to restore valve function. Delivered using percutaneous techniques, Duo is secured using a novel anchor system. This anchor system leaves the right heart and native valve apparatus untouched.
Dublin, Ireland-based CroíValve designed the straightforward implant procedure to suit a broad patient cohort. It uses standard imaging and accommodates the large anatomical variability seen in the target patient population. The company’s European first-in-human Tandem I trial showed strong symptomatic improvement in patients across all key measures. Those cases also demonstrated a quick-to-learn and easy-to-perform procedure.
“We are delighted to initiate TANDEM II, with strong interest in participation in the study from leading U.S. centers. This marks a significant step forward in our efforts to continue generating clinical evidence demonstrating the safety and effectiveness of Duo,” said Lucy O’Keeffe, CEO of CroíValve. “We are confident it has the potential to revolutionize the standard of care by redefining how TR is treated, and ultimately enhancing the lives of patients in need.”
A new personnel appointment for CroíValve, too
CroíValve also announced that it added Martin B. Leon as chair of its clinical advisory board. 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 (CICC) at New York-Presbyterian Hospital/Columbia University Medical Center.
He also serves on the executive board of the New York-Presbyterian/Columbia Heart Valve Center. Leon founded the Transcatheter Cardiovascular Therapeutics (TCT) symposium as well. He served as chair emeritus of the Cardiovascular Research Foundation (CRF).
“I’m excited about the study bringing this uniquely designed device to patients in the U.S. and guiding it as chair of the clinical advisory board,” said Dr. Leon. “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 anatomical exclusions, it can reach a broad population. It has the potential to emerge as a meaningful advancement in the field of TR treatment.”