Innavasc Medical, Inc. — Department of Health and Human Services STTR Phase I: 400

Description

Project Summary Abstract Synthetic arteriovenous grafts AVGs can provide life sustaining vascular access for dialysis patients but are subject to multiple modes of failure and complications related to chronic needle cannulation poor graft identification delayed access and bleeding These graft needle cannulation associated complications translate to millions of dollars in health care expenses hospitalizations pain and suffering To address this problem we have developed an immediate access hemodialysis graft that assures routine error free successful cannulation and prevents graft injury the Bullet Proof vascular graft This novel graft has been designed to be hemostatic durable easily identifiable and usable by dialysis technicians and patients alike In preliminary testing the Bullet Proof graft has been shown to be hemostatic self sealing resistant to posterior and sidewall penetration and more durable than current standard and early access dialysis grafts available for clinical use In this Phase I STTR application we will improve upon the current design of the Bullet Proof vascular graft Aim and will conduct a series of rigorous experiments to validate our pilot studies These experiments will consist of bench top testing designed to evaluate the self sealing resistance to back wall penetration and overall graft durability of our graft design when compared to that of the leading standard and early access vascular access grafts on the market today Aim The safety and effectiveness of our graft design will also be tested in vivo using a porcine dialysis graft cannulation model Aim In these experiments test and control grafts will be implanted and cannulated for up to weeks and evaluated for overall graft patency time to hemostasis and resistance to posterior graft wall injury Successful completion of this Phase I STTR project will result in an improved version of the Bullet Proof AVG approaching a finalized manufacturable design validation of the key design attributes of the graft and verification of the safety efficacy and patency of this novel dialysis graft technology Project Narrative Arteriovenous grafts AVGs are required by those with kidney failure in order to clear the toxins and excess fluid from their blood hemodialysis and injuries and complications of these AVGs are extremely common and result in infection pain and suffering These complications lead to millions in health care expenditures and the graftandapos s immediate use feature could eliminate the need for dialysis catheters which lead to expensive and deadly blood stream infections Our team has developed an immediate access hemodialysis graft that has been designed to be easily identifiable and usable by dialysis technicians and patients alike and assures routine error proof successful cannulation and prevents graft injury