CroíValve’s Duo Tricuspid Coaptation Valve System Evaluated in TANDEM I Trial in Poland

November 21, 2022—CroíValve recently announced the first-in-human (FIH) permanent implantation procedures of the company’s Duo tricuspid coaptation valve system for the treatment of tricuspid regurgitation (TR).

The procedures were part of the ongoing TANDEM I clinical trial that is being conducted at centers in Poland and were performed by Professor Adam Witkowski, MD, and Maciej Dąbrowski, MD, at the National Institute of Cardiology in Warsaw, Poland, and by Professor Wojciech Wojakowski, MD, at the Medical University of Silesia in Katowice, Poland.

According to the company, these early cases demonstrate that the Duo system is effective at treating TR and improves patient symptoms.

CroíValve’s 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 that 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, stated the company.

“The Duo system is unique in providing a solution that can effectively treat the dilated right heart anatomy that accompanies TR while avoiding contact with the right heart to maintain normal cardiac motion,” commented Prof. Witkowski in CroíValve’s press release. “After 30 days, our patient has already experienced a transformative improvement in symptoms, highlighted by the Kansas City Cardiomyopathy Questionnaire quality-of-life survey and a reduction from New York Heart Association III to New York Heart Association II and significant improvement in 6-minute walk test. In addition, the device continues to exhibit excellent efficacy.”

Prof. Wojakowski added, “This early use of the Duo system shows it’s an easy-to-use, safe, and effective device. 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 to treat patients we would otherwise have no option for.”

CroíValve, which is headquartered in Dublin, Ireland, was spun out of Trinity College Dublin in early 2019. In March 2020, the company announced the successful FIH use of its Duo technology in a temporary implantation procedure at St. James University Hospital Dublin, which was conducted under approval of the compassionate use program of the Irish regulatory body.