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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

About

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.

Outcome / Output

1. Completely indigenized technology 2. TC2 artificial valves reduce tissue overgrowth, reduces risk of valve thrombosis/thromboembolism, and improving the blood flow by increasing the area of flow. 3. Enhance the MRI compatibility by changing the frame material from Haynes 25 (cobalt alloy) to Ti6Al4V (Titanium alloy). 4. Improve thrombo-resistance and reduce bare metal exposure to the bloodstream by coating Titanium nitride (TiN) on the frame surface.
Quick Information
Thrust Areas
Medical Sciences
Focus Area
Devices and Diagnostics, Heart valve/implant, Biopharma
Status
completed
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