Commercialization of Tissue Lined Stent Graft for Dialysis Access Failure

用于透析通路失败的组织衬里覆膜支架的商业化

• 批准号: 8702678
• 负责人: Don Gustavson
• 金额: $ 41.58万
• 依托单位: PERITEC BIOSCIENCES
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-25 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8702678
• 关键词: Acute; Adult; Aging; American; Anastomosis - action; Animal Model; Animal Testing; Animals; Area; Biocompatible Materials; Biological; Blood; Blood Vessels; Blood flow; Cessation of life; Characteristics; Chronic; Chronic Kidney Failure; Clinical Research; Coagulation Process; Computer Assisted; Computer-Aided Design; Corrosion; Data Analyses; Development; Devices; Diabetes Mellitus; Dialysis procedure; Disease; Elasticity; End stage renal failure; Ensure; Equipment Malfunction; Experimental Designs; Failure; Fatigue; Finite Element Analysis; Fistula; Flare; Funding; Future; Goals; Healed; Hemodialysis; Histology; Human; Hypertension; Infection; Inflammatory Response; International; Kidney Failure; Length; Marketing; Materials Testing; Measures; Mechanics; Memory; Methodology; Methods; Metric; Modeling; Patients; Performance; Peripheral; Peritoneum; Phase; Polytetrafluoroethylene; Procedures; Process; Property; Prosthesis; Protocols documentation; Radial; Recurrence; Reporting; Risk; Shapes; Solutions; Staging; Stenosis; Stents; Stress; Surface; System; Tensile Strength; Testing; Time; Tissue Model; Tissues; Torsion; Toxic effect; United States; Veins; Venous; Visual; Writing; commercialization; cost; design; design and construction; diabetic; femoral artery; fluid flow; hazard; healing; improved; in vivo; meetings; minimally invasive; mortality; nitinol; novel; patient population; prototype; response; restenosis; scaffold; screening

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 factors such 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 degree of 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, i vivo 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.

描述（由申请人提供）：估计11.5%的成年人（约2300万人）患有慢性肾脏疾病。在终末期肾病患者中，死亡率约为每1000名患者年163.8例死亡。血液透析是美国超过34.1万名终末期肾病（ESRD）或肾衰竭患者的主要治疗方法，这可能是由糖尿病和高血压等常见慢性疾病引起的。由于并非所有患者都能等待瘘管成熟的时间，或者静脉脆弱的人不能使用它，因此AV移植市场正在增加。因此，随着终末期肾病（ESRD）的美国患者数量持续上升，移植物将继续作为血管通路的一种手段。随着血液透析患者中糖尿病患者人数的增长，移植需求也可能保持强劲。目前移植物的问题是它们有很高的凝血和再狭窄的可能性，也有很高的引起感染的可能性。他们经常在静脉吻合处发生狭窄，失败率很高。尽管人们热衷于聚四氟乙烯和其他生物移植物，但目前还没有理想的解决方案来治疗ESRD，因为它们尚未被证明是有效的血管通道。此外，原生的动静脉瘘也有很高的失败率