Commercial and Regulatory Development of an Enhanced Performance Hemodialysis Access Graft

PROJECT SUMMARY Objective: The goal of this SBIR CRP project is to move a novel hemodialysis access graft design through the major commercialization milestone of 510(k) submission. This STARgraft device is currently in an active clinical trial, with outcomes to date showing evidence of superior resistance to infection and occlusion failure compared to on-market grafts. There are two major task areas for this late-stage development project: • Formal testing against the FDA requirements and standards for this device type, including animal studies, in qualifying a replacement ePTFE core component for the silicone-ePTFE composite graft construction (the ePTFE core tubing used to date has been discontinued by the supplier). • 510(k) preparation, submission and clearance. Significance: The need for treatments at least 3 times per week makes maintenance of reliable vascular access for hemodialysis patients extremely challenging. More than half of all first-year hemodialysis patients, and 20% longer term, are treated via “last-resort” infection prone catheters. Successful clinical introduction of a synthetic AV graft with significantly increased resistance to infection and improved reliability in maintaining blood flow would increase access options and the quality of life for a significant number of patients, and very importantly, enable a significant reduction in the use of catheters. Innovation: The STARgraft approach is a new way to address both infection concerns and the recurrent venous- end stenosis failures in existing arterio-venous (AV) bypass access grafts. The STARgraft retains a conventional ePTFE core as the blood contact and primary structural element but features an exterior biointerface that incorporates with the surrounding tissue in a unique manner. This response exhibits a dramatically greater degree of vascularity than is found surrounding ePTFE-only devices, minimizing fibrotic capsule development and the consequent mechanical constriction effects on the graft. The vascularized and stress-relaxed tissue interface is more resistant to bacterial biofilm infections induced by repeated cannulations, and it allows the graft wall to elastically flex in response to pulsatile blood flow. Compared to a plain ePTFE graft, this flexure maintains a hemodynamic environment for blood cells and tissue inside the graft more closely resembling that in natural arteries and veins and provides longer-term flow stability. Approach: Specific aims of the CRP are straightforward: 1) Verify product design and development with the new core graft, 2) Validate in a 20-week GLP animal study, and 3) FDA 510(k) submission and clearance. Impact: 510(k) clearance, coupled with successful clinical results obtained prior and in parallel to the CRP project, will allow the company to attract the needed additional private investment for successful commercial launch, providing a safer and more reliable access graft option for a large number of dialysis patients. v0.73