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

Informazioni relative al progetto

Trisol System

ID dell’accordo di sovvenzione: 946589

DOI

10.3030/946589

Progetto chiuso

Data della firma CE 23 Marzo 2020

Data di avvio 1 Febbraio 2020

Data di completamento 31 Gennaio 2024

Finanziato da

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Costo totale

€ 3 321 336,00

Contributo UE

€ 2 324 935,20

Coordinato da

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)

Periodo di rendicontazione: 2021-02-01 al 2024-01-31

Sintesi del contesto e degli obiettivi generali del progetto

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.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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