CroíValve's DUO Tricuspid Coaptation Valve System advances from positive first-in-human results in Europe to a US Early Feasibility Study under FDA IDE approval.
April 10, 2026
11
min read
By
bioaccess® Team
**Key Takeaways**
- • CroíValve (Irish-US company) developed the DUO Tricuspid Coaptation Valve for severe tricuspid regurgitation
- • TANDEM I FIH in Poland with positive 6-month results presented at New York Valves 2024
- • TANDEM II US EFS initiated January 2024 with FDA IDE approval
- • $16M funding secured September 2024 for continued development
- • Percutaneous transcatheter approach — less invasive alternative to open-heart surgery
The short answer: CroíValve's DUO Tricuspid Coaptation Valve System advanced from the TANDEM I first-in-human study in Europe — reporting positive 6-month results in severe tricuspid regurgitation — to the TANDEM II US early feasibility study, backed by $16M in secured funding. Read how early feasibility studies run in Latin America.
What is the DUO tricuspid coaptation valve system?
CroíValve, an Irish-US structural heart company, has developed the DUO Tricuspid Coaptation Valve System — a percutaneous transcatheter device designed to treat severe tricuspid regurgitation (TR). Tricuspid regurgitation affects millions of patients worldwide and has historically been undertreated due to the high risks associated with open-heart surgery in this population.
The DUO system offers a minimally invasive alternative, delivered via a percutaneous transcatheter approach that avoids the need for sternotomy or cardiopulmonary bypass. This represents a significant advancement in the treatment of severe TR, which is associated with increased mortality, hospitalization, and reduced quality of life.
What did TANDEM I first-in-human show?
The TANDEM I first-in-human study was conducted in Poland, led by Prof. Wojciech Wojakowski. The study generated positive 6-month follow-up data that was presented at New York Valves 2024, one of the premier structural heart conferences.
The TANDEM I data demonstrated both the safety and feasibility of the DUO system's transcatheter approach for treating severe tricuspid regurgitation. These results provided the clinical evidence necessary to support progression to a US Early Feasibility Study under FDA IDE approval.
What is the TANDEM II US early feasibility study?
In January 2024, CroíValve initiated the TANDEM II Early Feasibility Study in the United States following FDA IDE approval. This represents the critical next phase in the DUO system's development, generating US clinical data under FDA oversight.
| Study | Phase | Location | Status |
|---|---|---|---|
| TANDEM I | First-in-Human | Poland (Europe) | Completed — positive 6-month data |
| TANDEM II | US Early Feasibility Study | United States (FDA IDE) | Initiated January 2024 |
How is continued development funded?
In September 2024, CroíValve secured $16 million in funding to support the continued clinical development and commercialization of the DUO system. This funding underscores investor confidence in the technology and the market opportunity for treating severe tricuspid regurgitation.
Why do structural heart FIH trials matter for Latin America?
The CroíValve story — from FIH in Europe to US EFS — illustrates the standard development pathway for structural heart devices. Latin America has become an increasingly important geography for first-in-human structural heart trials, offering:
- Experienced interventional cardiologists with international training
- Regulatory efficiency: clinical trial approvals in weeks rather than months
- Cost savings of 40–60% compared to US or European FIH studies
- FDA acceptance of clinical data generated under ICH-GCP standards
- Large patient populations with high prevalence of valvular heart disease
How does bioaccess® support structural heart device trials?
bioaccess® has supported numerous structural heart device companies with first-in-human trials and early feasibility studies across Latin America. With market access capabilities spanning the region, bioaccess® provides a complete pathway from FIH through commercialization.
**Planning a structural heart FIH trial?**
bioaccess® supports medtech companies developing transcatheter valve therapies, cardiac implants, and structural heart devices. Contact bioaccess® today or learn about our FIH-12™ program.
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