CroíValve has announced the successful first in human implants of its Duo tricuspid coaptation valve technology for the treatment of tricuspid regurgitation (TR) 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, Poland) by Adam Witkowski and Maciej Dąbrowski and the Medical University of Silesia (Katowice, Poland) by Wojciech Wojakowski.
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, the company said in a press release.
These early cases demonstrate that the Duo system is highly effective at treating TR and significantly improves patients’ symptoms, the press release goes on to state.
“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 Witkowski. “After 30 days, our patient has already experienced a transformative improvement in symptoms, highlighted by the Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life survey and a reduction from New York Heart Association (NYHA) III to NYHA II and significant improvement in six-minute walk test. In addition, the device continues to exhibit excellent efficacy.”
“This early use of the Duo system shows it is an easy to use, safe and effective device,” added 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.”