A transcatheter functional valve replacement for tricuspid valve insufficiency

Informations projet

Trillium

N° de convention de subvention: 190109977

DOI

10.3030/190109977

Projet clôturé

Date de signature de la CE 8 Juillet 2022

Date de début 1 Juin 2022

Date de fin 31 Mai 2026

Financé au titre de

• The European Innovation Council (EIC)

Coût total

€ 5 525 003,75

Contribution de l’UE

€ 2 500 000,00

Coordonné par

INNOVENTRIC LTD
Israel

Periodic Reporting for period 2 - Trillium (A transcatheter functional valve replacement for tricuspid valve insufficiency)

Période du rapport: 2023-10-01 au 2025-01-31

Résumé du contexte et des objectifs généraux du projet

Tricuspid regurgitation (“TR”) is a frequent disease with a graded increase in mortality as disease severity increases. The “still forgotten” TR patient population is ineligible for surgical or transcatheter on-valve treatments. This includes >40% of patients with challenging anatomy, lead-induced TR, failed prior tricuspid repair, poor tricuspid valve echo imaging, and prohibitive risk for TEE and GA. These patients have no treatment option with the current or pipeline transcatheter tricuspid valve therapies.

The Trillium™ offers ALL of these patients a simple, safe, and efficacious solution. The Trillium™ is a truly innovative heterotopic cross-caval tricuspid valve replacement specifically designed for the tricuspid valve environment. The Trillium™ is a stent graft with a valved wall that spans the right atrium with one end fixated in the SVC and the other end fixated in the IVC. The Trillium™ offers treatment for TR while leaving the native valve untouched. The procedure is simple, takes less than 10 minutes, and does not require Echo guidance or General anesthesia.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

160 devices were produced for various applications, including V&V testing, pre-clinical trials on the swine model, Biocompatibility lab testing, Sterilization validation protocols, LAL, and bioburden test for clean production zone monitorization.
Enrolment of 20 patients for the Trillium FIH study was completed in June 2023; by then, the Trillium™ had been implanted in 34 patients. In December 2024, The Trillium™ received FDA approval to initiate an EFS trial in the US were 15 patients will be enrolled for the trial, following a successful, Innoventric is is submitted for an IDE-Pivotal study as its next sizeable pivotal study in Europe and the US. Currently, the ESF study shows good results and progressing as planned.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

The Trillium™ technology has unique benefits for patients and physicians:
• Capable of treating the widest TR patient population
• <10 minutes device implantation time
• No migration
• No leaks
• No need for echo guidance
• No need for rapid pacing
• No need for General Anastasia

To ensure further uptake and success, Trillium™ technology needs to be further validated through the EFS study as a complementary step in assessing the Trillium™ final design before the commencement of a wide pivotal study in Europe and the US.

FDA approval of our IDE application for the Trillium™ EFS

Successful patient enrollment for Trillium™ FIH study

Successful Series B Funding