Ventricular reshaping for tricuspid regurgitation patients treatment.
The challenge
Tricuspid valve regurgitation is a heart condition affecting over 250,000 new patients every year in Europe and the US alone. Tricuspid regurgitation has a major impact on quality of life and survival, particularly in patients over 65, most of whom are women. It is associated with a one-year mortality rate of 36% and frequent hospitalizations, placing a significant burden on healthcare systems. Today, most patients rely on medical therapy, which alleviates symptoms but fails to halt disease progression. Surgical interventions remain high-risk, with significant intraoperative mortality.
The solution
Approxima is a MedTech start-up developing a percutaneous ventricular reshaping system for tricuspid regurgitation treatment by addressing its underlying cause—ventricular dilation. The system employs an implantable device consisting of two anchors connected by a tether, positioned on opposite sides of the right ventricle. Approximation of the anchors closer together reshapes the ventricle, restoring tricuspid valve function and improving overall right ventricular performance. This approach stands out as a unique concept within the tricuspid regurgitation space, leveraging clinical validation from similar application in the mitral valve space.
Its impact extends beyond the valve itself, stabilizing the size of the right heart. This approach restores tricuspid valve function while enhancing overall right heart performance. Designed to be efficient, straightforward, and reproducible, the percutaneous implantation procedure takes less than 10 minutes (in-vivo data), a significant improvement over the 1–3 hours required by competing solutions. The device boasts a minimal footprint and does not interact with the valve preserving therefore all future bailout options. The technology is patented in strategic geographies, and is supported by robust in-vivo feasibility, efficacy, and safety chronic data.
Expected impact
This project focuses on severe tricuspid regurgitation, a largely undertreated cardiovascular condition affecting over 3 million patients across the EU and the US. The technology aims to reduce the disease burden by improving clinical outcomes, enhancing the quality of life and significantly reducing hospitalization rates ultimately contributing to healthier aging and substantial healthcare cost savings.
External Partners
- Approxima Medical