CroíValve Initiate Early Feasibility Study for DUO Tricuspid Coaptation Valve System

CroíValve, a medtech company focused on solutions for tricuspid regurgitation (TR), has announced the initiation of its Early Feasibility Study (EFS) for the DUO Tricuspid Coaptation Valve System, following FDA Investigative Device Exemption (IDE) and Centers for Medicare and Medicaid Services (CMS) approval.

TR is a severe heart condition that occurs when the tricuspid valve fails to close properly, resulting in blood pumping backwards into the right atrium and venous system. The condition causes debilitating symptoms and can significantly impact quality-of-life. Currently, there are limited treatment options available to patients with TR.

CroíValve aims to fill the gaps in care with its DUO system, which consists of a coaptation valve that works in tandem with the native tricuspid valve to restore function. “The device is delivered using percutaneous techniques and is secured using a novel anchor system which leaves the right heart and native valve apparatus untouched,” according to the company press release. “The implant procedure is straightforward, uses standard imaging and is suitable for a broad patient cohort, accommodating the large anatomical variability seen in this patient population.

In the European First in Human Tamdem I trial, results showed strong symptomatic improvement in patients across all key measures, demonstrating the procedure was quick to learn and perform without the need to complex imaging.

For the EFS, called Tamdem II, CroíValve will further develop the clinical validation of the technology. The study is categorized as a prospective, multi-center, non-randomized single-arm study assessing the safety and performance of the system in patients with severe or greater symptomatic TR.

"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, in the release. “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."

In addition to the study announcement, the company also reported the appointment of Martin B. Leon, MD, as chair of its clinical advisory board. Leon has had a distinguished career in cardiovascular medicine. He is the Mallah Family Professor of Cardiology at the Columbia University Irving Medical Center College of Physicians and Surgeons, director of the Columbia Center for Interventional Care (CICC) at New York-Presbyterian Hospital/Columbia University Medical Center, serves on the executive board of the New York-Presbyterian/Columbia Heart Valve Center, and was the founder of Transcatheter Cardiovascular Therapeutics (TCT) symposium and Chairman Emeritus of the Cardiovascular Research Foundation (CRF).

“I’m excited about the study bringing this uniquely designed device to patients in the US and guiding it as chair of the clinical advisory board,” Leon said.