CroíValve Duo Evaluated for TR in 6-Month Results of TANDEM I Study

June 10, 2024—Ireland-based CroíValve announced that the TANDEM I first-in-human clinical trial of the company’s Duo system for percutaneous treatment of tricuspid regurgitation (TR) showed sustained positive outcomes in 10 patients at 6 months.

TANDEM I is a prospective, nonrandomized, multicenter study designed to evaluate the safety and performance of the Duo system in patients with severe symptomatic TR. The 30-day outcomes were presented in June 2023.

Professor Wojtek Wojakowski, MD, presented the 6-month findings at New York Valves 2024: The Structural Heart Summit held June 5-7 in New York, New York.

According to the company, the 6-month results demonstrated significant TR reduction by an independent core lab assessment. TR was reduced to moderate or less in > 85% of patients, even with massive or torrential TR at baseline. Patients also experienced markedly improved functional and quality-of-life outcomes, with a notable significant increase in both Kansas City Cardiomyopathy Questionnaire score and 6-minute walk test versus baseline.

Additionally, there was a 100% survival rate at 6 months. No incidences of arrhythmia or conduction disorder requiring permanent pacing were reported, demonstrating the advantages of avoiding right heart contact. These data also showed stable long-term device positioning and function while supporting natural reverse remodeling. The simplified procedural experience was highlighted by an average device time of 43 minutes, even with first use cases, stated the company.

“The 6-month results with the Duo system are highly promising, not only for its clinical safety and efficacy but also for the procedure’s simplicity and the technology’s broad applicability,” stated Prof. Wojakowski. “This system offers new hope for patients suffering from severe TR, providing a versatile and predictable treatment option that simplifies the procedural and imaging experience for operators.”

Prof. Wojakowski is Chief, Division of Cardiology and Structural Heart Diseases at the Medical University of Silesia in Katowice, Poland.

CroíValve stated that the Duo transcatheter coaptation valve works in tandem with the native tricuspid valve to restore valve function, using an anchor system that leaves the right heart and native valve apparatus untouched. The Duo system is an investigational device and not for sale in any geography.