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

Projektinformationen

Trisol System

ID Finanzhilfevereinbarung: 946589

DOI

10.3030/946589

Projekt abgeschlossen

EK-Unterschriftsdatum 23 März 2020

Startdatum 1 Februar 2020

Enddatum 31 Januar 2024

Finanziert unter

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Gesamtkosten

€ 3 321 336,00

EU-Beitrag

€ 2 324 935,20

Koordiniert durch

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)

Berichtszeitraum: 2021-02-01 bis 2024-01-31

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

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.

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

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

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

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