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

Información del proyecto

Trisol System

Identificador del acuerdo de subvención: 946589

DOI

10.3030/946589

Proyecto cerrado

Fecha de la firma de la CE 23 Marzo 2020

Fecha de inicio 1 Febrero 2020

Fecha de finalización 31 Enero 2024

Financiado con arreglo a

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coste total

€ 3 321 336,00

Aportación de la UE

€ 2 324 935,20

Coordinado por

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)

Período documentado: 2021-02-01 hasta 2024-01-31

Resumen del contexto y de los objetivos generales del proyecto

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.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

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

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

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