CALL FOR TECHNOLOGY TRANSFER – EXPRESSION OF INTEREST (EOI)

Mitral Annuloplasty Ring

Medical Device Classification : Class D

Technology Readiness Level : TRL 4

Intended end use : For repair of regurgitant mitral valve

Product description : This is a rigid complete mitral annuloplasty ring with a metallic core(CP Titanium grade 2) and covered by a polyester suture ring used for correction of mitral regurgitation.

Novelty : The ring has a 3D configuration confirming to shape of a healthy mitral annulus during mid systole
The suture fabric has proven excellent healing properties as demonstrated in TTK Chitra mechanical heart valve.
Variants of the same like a flexible ring, TiN coated inner core may be co-developed using the same design
Patent filed: Mitral Annuloplasty ring
Appln no: 202041044910 Date of filing: 15/10/2020

Current Development stage/ Evaluations done :
# Device design for all sizes of the device
# Design of accessories and jigs and fixtures for 3 sizes of device
# Prototypes made for 3 sizes of device
# In- vitro & fatigue testing done
# POC animal studies in 3 animals for 6 month period

Industry responsibility :
# Scale-up production
# Preclinical evaluation of device manufactured under ISO 13485
# Regulatory clearances
# Clinical trials

Deliverables from Institute : Technology Transfer documents on
# Device specification and design
# Raw materials and consumables
# Manufacturing process
# igs and fixtures
# Quality assurance and control
Training would also be provided to industry