Pilot Clinical Investigation of Rigid Tilting disc TTK Chitra-Titanium Heart Valve Model TC2 - the next version of the highly successful TTK-Chitra Heart Valve, Model TC1
Implementing Organization
Project Overview
A next generation rigid tilting disc TTK Chitra Titanium heart valve, Model TC2, with enhanced performance and MRI compatibility. The Model TC2 is made of Ultra High Molecular Weight Polyethylene disc, Titanium 6-aluminium 4-vanadium alloy frame and a Poly Ethylene Terephthalate sewing ring. The new design has undergone multiple stages of design verification including in silico verification, in vitro assessments and comprehensive pre-clinical in vivo evaluation using animal models, conforming to the requirements of IS/ISO 5840:2005, ISO 5840:2015 and is now investigated through phase I clinical trials.
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