Product and Regulatory Development of a Needle-Free Hemodialysis Access Port

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Product and Regulatory Development of a Needle-Free Hemodialysis Access Port PROJECT SUMMARY Objective: The overall objective of this SBIR Phase IIB Bridge Award project is to advance a new Needle-Free Hemodialysis Access Port to the stage of IDE approval for a subsequent first in Human study. Significance: For the nearly 500,000 End Stage Renal Disease (ESRD) kidney failure patients in the US on hemodialysis (HD), the need for thrice-weekly in-clinic treatments requiring cannulation by large dialysis needles (up to 2 mm diameter) is time consuming, painful and unpleasant and makes maintenance of a reliable vascular access site extremely challenging. As a result of high failure rates with the established permanent vascular access methods – arteriovenous (AV) fistulas and AV grafts – more than half of all first-year hemodialysis patients, and more than 20% longer term, are treated via infection-prone catheters. There are frequent hospitalizations with unsustainable costs to the healthcare system and a miserable quality of life for most patients. Home HD treatment saves $20,000 per patient year, can be done at the patient’s convenience, significantly improves patient health, and has the major quality-of-life benefit of enabling many patients to continue productive employment. Patient surveys cite needle aversion as the biggest obstacle to increased home self-treatment. A new access option that overcomes this barrier would encourage increased home HD. Innovation: Previous percutaneous port devices providing blunt cannula access to the lumen of an AV graft were functional and patient-appreciated but eventually failed clinically and commercially from infection issues at the exit site and poor patency of the grafts. Healionics has developed technologies that overcome these issues by use of its STAR porous biomaterial at tissue interfaces, enabling a reintroduction of the needle-free HD access port concept. STAR’s optimized pore geometry induces a permanently vascularized tissue interface that leverages the body’s natural defenses against bacterial infection. Application of STAR to the outside of an AV graft eliminates capsular contraction forces, preserving graft wall flexibility and preventing the usual failure mode of progressive venous-end neointimal hyperplasia. Improvements to the hemostasis valve design and other components are expected to further improve reliability and safety versus earlier port devices. Approach: Specific aims for the project are 1) extend the prototype development and initial preclinical testing done under R44HL26256 into a more complete device design, 2) conduct formal technical verification, fabrication process development, reliability testing and preclinical studies, and 3) prepare and submit a successful IDE application to the FDA. IDE approval will allow a first-in-human Early Feasibility Study to begin soon after conclusion of the SBIR Phase IIB project period, supported by investment funding secured during the SBIR project period. Impact: Project success would enable significant reductions in the use of high-risk catheters and circumvent the main barrier to increased self-care at home. This would greatly reduce the cost of kidney failure care and improve patient safety and quality of life for a significant part of the ESRD patient population. v0.34