Cardiovascular Patch Protection System Using a Durable, Self-sealing Material

Period of Performance: 05/15/2017 - 03/31/2018


Phase 2 SBIR

Recipient Firm

Solinas Medical, Inc.
Principal Investigator


Project Summary This Small Business Innovation Research Phase II project supports the development of an instantly sealing vessel protection platform with enhanced durability against needle sticks. While Medicare spends over $30 billion annually on the treatment for end-stage renal disease, greater than 7% of its budget, $1.5 billion is spent treating preventable access-related complications. Many of these complications are directly or indirectly a result of repeated large bore needle cannulations and methods used to manage the access site after treatment. The technology will be the first product to prophylactically serve the AV fistula market and creates an untapped market with greater than $200 million in the U.S. This project will expand knowledge on methods to improve vascular access designed to address secondary complications instead of relying on conventional approaches of treating the complications after they have occurred. Success of this research will increase understanding on methods of creating materials for applications where closure and re-traversable access is desired. The primary value proposition of the proposed technology is to offer a prophylactic means of protecting AV access systems that undergo rapid degeneration by reinforcing the site of repeated cannulation. In an effort to support our commercialization launch the objective of the scientific aims is to demonstrate the clinical safety and effectiveness of the patch system in addressing persistent access-related complications. Specifically, the scientific aim is to conduct a prospective, clinical trial to evaluate the safety and efficacy of the patch technology in patients undergoing hemodialysis with an AVF.