![](\"\/wp-content\/uploads\/BMT-wing\/TiN_coated_coronary_stent.jpg\")
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Intended end use :<\/b>\u00a0The 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.<\/p>\nProduct description :<\/b>\u00a0The Chitra coronary stent consists of the following components:
\n1. L605 based Metal Stent platform
\n2. Titanium Nitride Ceramic coating\n
Novelty(please specify patents if any filed) :<\/b>\u00a0Patent granted, 357096 dated 29\/01\/2021<\/p>\nCurrent Development stage\/ Evaluations done :<\/b>
\n# Design and choice of materials completed. 12 TiN coated coronary stent are prototyped.
\n# Design Verification: The safety and performance of the design has been assessed in vitro and in silico by:
\n(a) Stent diameter to balloon expansion characterization as per ASTM 2081-06 (2017)
\n(b) Dimensional verification as per ASTM F2081-06 (Reapproved 2017)
\n(c) Recoil study as per ASTM F2079, ISO 25539-2
\n(d) Foreshortening study as per ASTM 2081-06 (2017)
\n(e) Percent solid area study as per ASTM 2081-06 (2017)
\n(f) Computational structural analysis (ASTM F2514-08 Reapproved 2014)
\n(g) Fatigue & durability- computational analysis (ASTM F2514)
\n(h) Flexibility of stent as per ASTM F2606-08 (Reapproved 2014)
\n(i) Flexibility of stent system as per ASTM F2606-08 (Reapproved 2014)
\n(j) Dogboning studies as per ISO\/DIS 25539-2:2019(E)
\n(k) Deflation time at labeled RBP as per ISO\/DIS 25539-2:2019(E)
\n(l) Deflation time corresponding to deployed diameter as per ISO\/DIS 25539-2:2019(E)
\n(m) TiN coating thickness measurement as per ISO\/DIS 25539-2:2019(E)
\n(n) TiN coating surface roughness as per ISO\/DIS 25539-2:2019(E)
\n(o) TiN coating integrity as per ISO\/DIS 25539-2:2019(E)
\n(p) TiN coating trace element analysis as per ISO\/DIS 25539-2:2019(E)
\n(q) DFSS based robustness (z) assessment: Critical to Quality parameters, vendor evaluation of raw materials and manufacturing process.
\n(r) POC Animal studies- Completed animal studies of 3 Chitra stents
\nThe safety and performance indicators showed that the Chitra Stent is safe.\nIndustry responsibility for technology transfer :<\/b>
\n# Preclinical evaluation
\n# Clinical trials
\n# Instructions For Use
\n# Packaging
\n# Regulatory\nDeliverables from Institute :<\/b>\u00a0Technical Documentation
\nWork procedures & Test reports (21 Nos)
\nDesign dossier
\nTechnology Transfer Documentation (jointly with Industry)
\n# TTDOC1- Design & specifications
\n# TTDOC2- Raw materials and consumables
\n# TTDOC3- Equipment and Utilities
\n# TTDOC4- Jigs and fixtures
\n# *TTDOC5- Manufacturing process
\n# *TTDOC6- QA\/QC\n
![](\"\/wp-content\/uploads\/BMT-wing\/TiN_coated_coronary_stent-1.jpg\")
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