November 22, 2022 — CroíValve has announced the successful First in Human implants of its DUO Tricuspid Coaptation Valve technology for the treatment of Tricuspid Regurgitation as part of its TANDEM I study in Poland. The procedures were performed as part of an ongoing clinical trial at the National Institute of Cardiology, Warsaw by Prof Adam Witkowski and Dr Maciej Dąbrowski and the Medical University of Silesia in Katowice by Prof Wojciech Wojakowski.
Tricuspid Regurgitation (TR) is a severe heart condition that occurs when the tricuspid valve, on the right side of the heart, fails to close properly. This results in blood being pumped backwards into the right atrium and venous system causing debilitating symptoms. The DUO System consists of a coaptation valve implant that works in tandem with the native tricuspid valve to restore valve function. The device is delivered using minimally invasive techniques and is secured using a novel anchor system which leaves the frail right heart chamber and native valve apparatus untouched. The implant procedure is straightforward, uses standard imaging and is suitable for a broad patient cohort, including those who are challenging to treat with other valve repair and replacement technologies.
These early cases demonstrate that the DUO System is highly effective at treating TR and significantly improves patients’ symptoms. This is achieved with a straightforward, short procedure, that is easy for the patient to tolerate and for the physician to perform.
“The DUO System is unique in providing a solution that can effectively treat the dilated right heart anatomy that accompanies Tricuspid Regurgitation, while avoiding contact with the right heart to maintain normal cardiac motion,” commented Prof Adam Witkowski. “After 30 days, our patient has already experienced a transformative improvement in symptoms, highlighted by the KCCQ Quality of Life survey and a reduction from NYHA III to NYHA II and significant improvement in 6MWT. In addition, the device continues to exhibit excellent efficacy.”
“This early use of the DUO System shows it’s an easy to use, safe and effective device” added Prof Wojciech Wojakowski. “Even though it was our first use of the DUO System, the procedure was very straightforward, which is highlighted by the short procedure time. It is a stepwise, controlled approach using standard echo and fluoro imaging and allows us treat patients we would otherwise have no option for”.
"This achievement is an important milestone on our journey to implement the DUO System as the gold standard approach for treating Tricuspid Regurgitation. We'd like to thank the Heart Teams at the National Institute of Cardiology, Warsaw and the Medical University of Silesia in Katowice. We are excited by this early clinical experience in demonstrating a transformative treatment option for these patients." said Lucy O’Keeffe, CroíValve’s CEO.
For more information: https://www.croivalve.com/