Commercialization of Tissue Lined Stent Graft for Dialysis Access Failure

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R44DK091156-01A1
Agency Tracking Number: R44DK091156
Amount: $1,024,966.00
Phase: Phase I
Program: SBIR
Awards Year: 2012
Solicitation Year: 2012
Solicitation Topic Code: NIDDK
Solicitation Number: PA11-096
Small Business Information
10000 cedar avenue, Cleveland, OH, 44195-
DUNS: 156106952
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (216) 334-4420
Business Contact
Phone: (216) 334-4420
Research Institution
DESCRIPTION (provided by applicant): An estimated 11.5 percent of adults (approx 23 million people) suffer from chronic kidney disease. Among people suffering from ESRD, the mortality is approximately 163.8 deaths per 1,000 patient years. Hemodialysis is the leading treatment for more than 341,000 patients in the United States with end-stage renal disease (ESRD), or kidney failure, which can be caused by common chronic conditions such as diabetes and hypertension. The market for AV grafts is increasing since not all patients can wait the length of time for the fistula to mature or it cannot be used for people with fragile veins. Thus, s the number of Americans with end-stage renal disease (ESRD) continues to rise, the use of grafts will continue to be employed as a means of vascular access. As the number of diabetics within the hemodialysis patient population grows, it is also likely that graft demand will remain strong. The problem with the current grafts is their high potential for clotting and restenosis,an high potential for causing an infection. They frequently develop stenoses at the venous anastomosis and have a high rate of failure. Despite enthusiasm for PTFE and other biological grafts, there is no ideal solution to treating ESRD, as they have not been proven to be efficacious as a vascular access. Additionally, native arterial venous fistulas also a high failure rate PeriTec Biosciences has developed a novel peritoneum lined stent (PLS). The PLS has shown excellent performance in animal and international human clinical studies for both dialysis access failure and femoral artery occlusive disease. Peritec now aims to develop the stent graft to use as a treatment method to improve dialysis access stenosis. These unique tissue lined stents require special handling in a novel delivery system developed by the company to maintain their physical and biological integrity. Peritec has developed a more efficient and safe stent scaffold specifically designed to accommodate the tissue; the desired characteristics include different radial forces and flared ends. This development will take place over the next 3 years. Phase I is underway and we seek funding to accelerate development. Computer aided design (CAD) models will be tested for various non-clinical factorssuch as fluid flow analysis, risk analysis, and material characterization of stents. All tests will be performed under ASTM standards and appropriate FDA requirements will be met. Phase II, includes mechanical tests of the tissue stents to a higher degreeof function. Accelerated fatigue tests will be done with the objective of determining the relationship between the stress range and number of times it can be applied before failure. These specific tests are Pulsatile and Axial/Torsion Testing. Finally, ivivo animal testing will be performed to validate our stent designs. This will allow the use of the unique tissue lined Peritec stents to meet a serious and growing unmet need in the treatment of End Stage Renal Disease. PUBLIC HEALTH RELEVANCE:With the rapid increase in the people suffering from End Stage Renal Disease associated with aging, hypertension, and diabetes, there is a serious unmet need for creating a suitable vascular access to perform hemodialysis. Unfortunately, while the existinginitial procedures are effective in the acute stage, recurrent failure is the nom. The cost of failure is very high. One highly touted minimally invasive procedure designed to improve on these failures is using the combination of a stent and prosthetic (called a stent graft) The mechanical stent props open the blockage, and the prosthetic provides a new surface for the blood to flow through. However, after just a short period of time the prosthetic causes an inflammatory response, which leads to yet another recurrent failure. Additionally, native arterial venous fistulas also have high failure rates, albeit they do perform better than AV grafts. The vein may not mature properly to a size where blood flow is sufficient and the fistula requires months to healand the vein may become more difficult to cannulate compared to a graft. Our goal is to improve the patency in the patients intervened on with failing arteriovenous grafts and fistulas. We believe that intervening with a stent graft with a biological material attached to it an improve patency. Peritec has developed a biologically tissue lined stent which will improve on current results.

* Information listed above is at the time of submission. *

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