Periodic Reporting for period 1 - Trisol System (A safe and effective replacement valve for treating severe Tricuspid Regurgitation and preventing Right Ventricle dysfunction)
Reporting period: 2020-02-01 to 2021-01-31
Trisol device is a Transcatheter Tricuspid Valve Replacement, which is implanted easily and intuitively. Trisol valve is constructed out of nitinol frame with specially designed dome-shaped leaflet. Its unique design provides a comprehensive solution to eliminating Tricuspid Regurgitation while preserving the Right Ventricle function. Trisol Valve is suited to all severe Tricuspid Regurgitation patients.
The objectives of the proposed project include finalization of device safety assessment through animal studies, and validation of Trisol valve’s safety and performance in human studies to pursue CE Marking.