Biointegrated Synthetic Grafts for Reconstruction of Vascular Tissue

Period of Performance: 02/22/2016 - 07/21/2018


Phase 2 SBIR

Recipient Firm

Healionics Corporation
Firm POC
Principal Investigator


Use of existing smaller prosthetic grafts for vascular repair and reconstruction after severe trauma to the extremities is greatly limited by issues with stenosis and infection. We propose treating the exterior of ePTFE vascular grafts with STAR biomaterial, a well-developed microporous synthetic tissue scaffold already in human use. STAR prevents the usual formation of a constrictive fibrotic perigraft tissue capsule. Mechanical constriction effects are eliminated, permitting greater freedom for natural pulsatile and vibratory motion of the graft wall. This suppresses progression of neointimal hyperplasia by alleviating compliance mismatch and providing more favorable stress conditions at the ePTFE-neointima interface. The STAR biointerface also addresses the infection risk of ePTFE grafts; STAR biomaterial harnesses the bodys natural antimicrobial defenses by concentrating immune cells to resist infections. These biological responses are regulated by the tightly controlled and optimized porous geometry and do not require use of added biologics. Promising preliminary results suggest that this approach can lead to a major improvement in clinical performance and reliability. Phase II technical objectives are demonstrating advantages of superior patency and infection control in an ovine arterial bypass model with controlled bacterial challenge, and performing needed bench testing towards qualifying the novel graft design for human use.