A transcatheter functional valve replacement for tricuspid valve insufficiency

Project Information

Trillium

Grant agreement ID: 190109977

DOI

10.3030/190109977

Project closed

EC signature date 8 July 2022

Start date 1 June 2022

End date 31 May 2026

Funded under

• The European Innovation Council (EIC)

Total cost

€ 5 525 003,75

EU contribution

€ 2 500 000,00

Coordinated by

INNOVENTRIC LTD
Israel

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

Reporting period: 2023-10-01 to 2025-01-31

Summary of the context and overall objectives of the project

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.

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

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.

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)

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