Silk Vascular Grafts with Optimized Mechanical Properties for the Repair and Regeneration of Small Caliber Blood Vessels.

As the incidence of cardiovascular diseases has been growing in recent years, the need for small-diameter vascular grafts is increasing. Considering the limited success of synthetic grafts, vascular tissue engineering/repair/regeneration aim to find novel solutions. Silk fibroin (SF) has been widely investigated for the development of vascular grafts, due to its good biocompatibility, tailorable biodegradability, excellent mechanical properties, and minimal inflammatory reactions.

A Route to Translate a Silk-Based Medical Device from Lab to Clinic: The Silk Biomaterials Srl Experience.

The medical device is a nerve conduit entirely made of silk fibroin. It is a tubular scaffold used for repairing peripheral nerve gaps, whose function is to protect the severed nerves and to favor their natural healing process. As any implantable medical device, the conduit must perform its function without causing adverse effects to the patient, meaning that it must be compliant with a range of regulations aimed at evaluating the risks related to the constituent materials and the manufacturing process, the toxicological impact of the processing aids, the biological safety, the functional performance, and the ability to sustain tissue regeneration processes.