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Minimally invasive transcatheter system for tricuspid heart valve replacement

Periodic Reporting for period 1 - TRICARIX (Minimally invasive transcatheter system for tricuspid heart valve replacement)

Reporting period: 2018-12-01 to 2020-02-29

Cardiac surgeons are urgently seeking for a low-risk minimally invasive (transcatheter) solution to treat >300,000 patients with tricuspid heart valve disease annually, that are currently simply dying because of having no relevant therapeutic option. TRiCares has uniquely addressed technological challenges associated with tricuspid heart valve disease treatment by developing safe and effective minimally invasive system for the tricuspid valve replacement.
The objective of this project is to verify and validate the TRiCares Tricuspid Heart Valve Replacement System including extensive bench and preclinical testing as well as a First in Man (FIM) Clinical Study as a preparation for later clinical investigations required for CE market approval.
In the first period of the TRICARIX project the chosen design of the tricuspid valve prosthesis and the subsequent implantation system have been prepared for extensive bench testing and supported by finite elements assessment and other computer modelling. The bench testing includes biological evaluation and preclinical animal implantation studies as a preparation for later human safety studies. Furthermore, the regulatory infrastructure is going to be implemented by establishing a quality management system and its certification by a notified body.
In parallel the commercialization plan is actively followed with activities in commercialization, market access preparation and management of the intellectual property portfolio.
As the results of the first period of the TRICARIX are challenging the company expects successful outcomes of the open studies, especially the preclinical animal study and the First in Man safety study in human. These are milestones on the way to the final goal, the regulatory CE market approval for Europe. However, the introduction of the new Medical Device Regulation (MDR) still causes several uncertainties at all stakeholders like competent authorities, notified bodies and manufacturers and might have an impact on the project plan and the expected timeline. Recently, the Corona pandemic will definitely have a currently not foreseeable impact on the project because of shutdowns of subcontractors and laboratories.
TRICARIX is a proprietary tricuspid heart valve replacement system, based on delivery of a biological valve by a catheter through transfemoral vascular access and subsequent implantation of the valve by a proprietary mechanical dual-stent prosthesis system. TRICARIX carries substantially lower risk than the current open-heart surgical procedures and brings therapeutic solution to >300,000 TR patients annually, that are currently not eligible for any treatment option. The unique dual-stent prosthesis design serves as a platform for replacement of other heart valves, targeting even larger patient populations.
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