Skip to main content

Minimally invasive transcatheter system for tricuspid heart valve replacement

Periodic Reporting for period 2 - TRICARIX (Minimally invasive transcatheter system for tricuspid heart valve replacement)

Reporting period: 2020-03-01 to 2021-02-28

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.
The second period of the TRICARIX project from March 20 until February 21 was focused on extensive bench and preclinical testing and establishing a Quality Management System for TRiCares.
Based on the recommendations of the biological evaluation plan of the prosthesis, several tests were performed according to the international ISO 10993 standard like cytotoxicity testing, chemical characterization of leachable and extractables, sensitization, sensibilization, pyrogenicity testing and hemocompatibility evaluations. Finally, based on the results of the chemical characterization further genotoxicity tests were required which are still ongoing.
For the implantation and loading system a biological evaluation plan was written and biocompatibility tests are conducted accordingly.
An overall biological assessment has been conducted and has been reported in a biological evaluation report of the devices (see deliverable D 2.1).
Furthermore, the preclinical in-vivo assessment was performed with an implantation of the tricuspid heart valve in 10 male adult sheep. After three months the animals were sacrified and macroscopically and histologically evaluated. For a summarizing report see deliverable D 2.2.
In parallel, the structural performance assessment was conducted consisting of implant durability testing, fatigue assessment, and component corrosion assessment. These long-term tests of 200 and 400 Mio cycles are still ongoing and expected to be finished in the second half of 2021.
As a prerequisite for submission of technical files to competent authorities and notified bodies TRiCares had to establish a quality management system according to DIN EN ISO 13485:2016. This QMS covers all processes within the company and will be audited and certified by the notified body. The QMS audit took place successfully in January 2021 and the certificate will be issued within the next days.
Because of the Corona pandemic several other activities like dissemination and communication as well as market access preparation of the TRICARIX project had to be cancelled or transferred to the virtual world. In 2020, all scientific congresses were conducted online. Therefore, there was no opportunity to meet potential users and other stakeholders personally and to show the improvement of the products.
The Corona pandemic has also impacted the timelines of the project. In conclusion, it was not yet possible to start the First in Human trial as planned and the important meetings with suppliers to work on the final design and improvements had to be postponed until the end of the pandemic.
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.
Tricares logo