Medical Device Classification : Class D
Technology Readiness Level : TRL 5
Intended end use : Cardio-vascular patch
Product description : Thin and pliable (< 0.2mm), biocompatible, bioresorbing decellularised porcine pericardium which is strengthened by impregnating a natural protein – silk fibroin. This product is non-calcifying, remodelable and resorbs with time while allowing replacement with host tissue. This product finds application especially in pediatric cardio-vascular surgery for correction of congenital cardio-vascular defects
Novelty : Augmentation of mechanical strength by silk fibroin impregnation is novel. (Patent applied)
Current Development stage/ Evaluations done :
# Proof of concept completed, including mechanical and structural characterization, biocompatibility evaluation (ISO 10993), and small and large animal functional safety study.
Industry responsibility :
# Scale-up production
# Completion of Preclinical and clinical evaluation of device
# Obtaining regulatory clearances for sale
Deliverables from Institute :
Technology Transfer documents on the device and its quality assurance.
Training to industry for pilot production of the device.