The fourth period of the TRICARIX project from March 2022 until November 2022 was focused on the dissemination and exploitation of the project results, which were achieved so far and the preparation for the first implantations for the First in Human study.
For the tricuspid heart valve prosthesis, the design verification testing were completed at the start of the reporting period and a design review to confirm the readiness for clinical applications were performed in June 2022. However, further long-term testing was started to fulfill other regulatory requirements, e.g. for FDA approval fatigue testing of 600 Million cycles are required instead 400 Million cycles according to the new ISO 5840-1.
Furthermore, the manufacturing of the prosthesis was focused, and several process validations activities were started e.g. cleaning validation, packaging validation etc.
Also for the implantation system, consisting of different components, like delivery catheter, steerable sheath and dilator and the loading system, the design verification and validation testing were started and first batches were manufactured under batch release conditions for the ongoing clinical activities.
The compassionate use program started in 2021, where the developed devices were implanted in patients with life-threatening conditions to gain access to unapproved investigational medical devices.
In the meantime 11 patients were treated successfully. TriCares was happy to provide the tricuspid heart valve replacement system to these hospitals to help such patients.
In December 2021 technical documentation of the Topaz heart valve system were submitted to Swissmedic, the competent authority in Switzerland, followed by a submission to ANSM, the French Competent Authority and the Belgium competent authority. In parallel the corresponding ethical submissions were prepared and send to the ethic committees in the same countries.
After reviewing the technical documentation the competent authorities of Switzerland and France asked for additional structural performance testing. For this reason the submissions in both countries were rejected and new tests are initiated. As these tests (durability assessment and fatigue testing) are long-term trials, a new submission for a FIH clinical investigation can only take place earliest in 2023. However, TRiCares received a positive feedback from the competent authority and ethic committee in Belgium in June 2022 and the first patient was enrolled in August 2022. Until the end of the reporting period two patients were successfully treated with the TRiCares Topaz Transfemoral Tricuspid Heart Valve Replacement System and a third patient will be implanted in Dec. 2022. In parallel TRiCares is working in parallel on a submission for an Early Feasibility Study (EFS) in the US to gain more patients and safety data of our innovative solution.
