A safe and effective replacement valve for treating severe Tricuspid Regurgitation and preventing Right Ventricle dysfunction

Project Information

Trisol System

Grant agreement ID: 946589

DOI

10.3030/946589

Project closed

EC signature date 23 March 2020

Start date 1 February 2020

End date 31 January 2024

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 3 321 336,00

EU contribution

€ 2 324 935,20

Coordinated by

TRISOL MEDICAL LTD
Israel

Periodic Reporting for period 2 - Trisol System (A safe and effective replacement valve for treating severe Tricuspid Regurgitation and preventing Right Ventricle dysfunction)

Reporting period: 2021-02-01 to 2024-01-31

Summary of the context and overall objectives of the project

Severe Tricuspid regurgitation (TR) or tricuspid valve insufficiency, is a common valve disorder that contributes to both significant morbidity (right heart failure) and mortality. TR is a disorder in which the tricuspid valve does not close properly. This problem causes blood to flow backward into the right upper heart chamber (atrium) when the right lower heart chamber (ventricle) contracts. Many cases of Tricuspid Regurgitation are accompanied by the Dysfunction of the Right Ventricle. Today, the gold standard for treating the disorder is open-heart surgery. However, due to high surgical mortality rate and periprocedural morbidity, the surgical approach is highly risky for typical patients with symptomatic TR. Thus, only a small percentage of surgical procedures are performed in Europe annually, out of 2 million patients who suffer from moderate to severe TR, pointing to a critical unmet need.
Trisol device is a Transcatheter Tricuspid Valve Replacement, which is implanted easily and intuitively. Trisol valve is constructed out of nitinol frame with specially designed dome-shaped leaflet. Its unique design provides a comprehensive solution to eliminating Tricuspid Regurgitation while preserving the Right Ventricle function. Trisol Valve is suited to all severe Tricuspid Regurgitation patients.
The objectives of the proposed project include finalization of device safety assessment through animal studies, and validation of Trisol valve’s safety and performance in human studies.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Within the project, Trisol has been actively working on validating the Trisol valve’s safety through extensive V&V processes and animal testing for obtaining Ethics Committees approval and advance to clinical studies. The system was presented in conferences and events, enabling Trisol to strengthen their network of Key Opinion Leaders. Trisol valve was implanted in 17 patients with severe to torrential TR. The studies outcomes show that:
o It is safe and feasible to implant Trisol Valve in humans
o Trisol Valve functions well chronically
o Trisol valve can potentially prolong the patient’s life and improve its quality of life
o An acute improvement of RV function was noted following Trisol Valve implant

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Trisol aims to demonstrate safety and efficacy of its valve in clinical trials in selected hospitals across Europe and Israel, and collect the clinical evidence required for CE Mark certification and market launch. The EIC project will enable to progress in the path to release the Trisol Valve into the European marketplace and provide a unique solution to reduce the vast societal and economic burden of Tricuspid regurgitation.

Trisol Valve Design and Unique Advantages