TiN coated coronary stent system

Intended end use : The Cobalt-Chromium-Nickel-Tungsten alloy L605 based, Titanium Nitride coated “bare metal” coronary stent system is indicated for improving coronary luminal diameter in patients with native coronary lesion length < 50 mm, and reference vessel diameter (D Ref Vessel) ranging from 2.0 mm < D Ref Vessel < 4.50 mm.

Product description : The Chitra coronary stent consists of the following components:
1. L605 based Metal Stent platform
2. Titanium Nitride Ceramic coating

Novelty(please specify patents if any filed) : Patent granted, 357096 dated 29/01/2021

Current Development stage/ Evaluations done :
# Design and choice of materials completed. 12 TiN coated coronary stent are prototyped.
# Design Verification: The safety and performance of the design has been assessed in vitro and in silico by:
(a) Stent diameter to balloon expansion characterization as per ASTM 2081-06 (2017)
(b) Dimensional verification as per ASTM F2081-06 (Reapproved 2017)
(c) Recoil study as per ASTM F2079, ISO 25539-2
(d) Foreshortening study as per ASTM 2081-06 (2017)
(e) Percent solid area study as per ASTM 2081-06 (2017)
(f) Computational structural analysis (ASTM F2514-08 Reapproved 2014)
(g) Fatigue & durability- computational analysis (ASTM F2514)
(h) Flexibility of stent as per ASTM F2606-08 (Reapproved 2014)
(i) Flexibility of stent system as per ASTM F2606-08 (Reapproved 2014)
(j) Dogboning studies as per ISO/DIS 25539-2:2019(E)
(k) Deflation time at labeled RBP as per ISO/DIS 25539-2:2019(E)
(l) Deflation time corresponding to deployed diameter as per ISO/DIS 25539-2:2019(E)
(m) TiN coating thickness measurement as per ISO/DIS 25539-2:2019(E)
(n) TiN coating surface roughness as per ISO/DIS 25539-2:2019(E)
(o) TiN coating integrity as per ISO/DIS 25539-2:2019(E)
(p) TiN coating trace element analysis as per ISO/DIS 25539-2:2019(E)
(q) DFSS based robustness (z) assessment: Critical to Quality parameters, vendor evaluation of raw materials and manufacturing process.
(r) POC Animal studies- Completed animal studies of 3 Chitra stents
The safety and performance indicators showed that the Chitra Stent is safe.

Industry responsibility for technology transfer :
# Preclinical evaluation
# Clinical trials
# Instructions For Use
# Packaging
# Regulatory

Deliverables from Institute : Technical Documentation
Work procedures & Test reports (21 Nos)
Design dossier
Technology Transfer Documentation (jointly with Industry)
# TTDOC1- Design & specifications
# TTDOC2- Raw materials and consumables
# TTDOC3- Equipment and Utilities
# TTDOC4- Jigs and fixtures
# *TTDOC5- Manufacturing process