Commercialization of Tissue Lined Stent Graft for Dialysis Access Failure

描述（由申请人提供）：估计有11.5%的成年人（约2300万人）患有慢性肾脏疾病。在患有ESRD的人群中，死亡率约为每1，000患者年163.8例死亡。血液透析是美国341，000多名终末期肾病（ESRD）或肾衰竭患者的主要治疗方法，这些患者可能由糖尿病和高血压等常见慢性疾病引起。AV移植物的市场正在增加，因为不是所有患者都可以等待瘘管成熟的时间长度，或者它不能用于静脉脆弱的人。因此，随着美国终末期肾病（ESRD）患者数量的持续增加，移植物将继续作为血管通路的一种手段。随着血液透析患者人群中糖尿病患者数量的增长，移植物需求也可能保持强劲。目前的移植物的问题是它们的凝血和再狭窄的可能性很高，导致感染的可能性很高。它们经常在静脉吻合处发生狭窄，并且失败率很高。尽管对PTFE和其他生物移植物充满热情，但没有治疗ESRD的理想解决方案，因为它们尚未被证明是有效的血管通路。此外，自体动静脉内瘘的失败率也很高， PeriTec Biosciences开发了一种新型腹膜内衬支架（PLS）。PLS在动物和国际人体临床研究中表现出出色的性能，用于治疗透析通路失败和股动脉闭塞性疾病。Peritec现在的目标是开发覆膜支架，用作改善透析通路狭窄的治疗方法。这些独特的组织内衬支架需要在公司开发的新型输送系统中进行特殊处理，以保持其物理和生物完整性。Peritec开发了一种更有效、更安全的支架，专门设计用于容纳组织;所需的特性包括不同的径向力和扩口端。这一发展将在未来三年内进行。第一阶段正在进行中，我们寻求资金以加快发展。将对计算机辅助设计（CAD）模型的各种非临床因素进行测试，例如流体流动分析、风险分析和支架材料表征。所有试验将根据ASTM标准进行，并符合适当的FDA要求。第二阶段，包括组织支架的机械测试，以达到更高的功能程度。将进行加速疲劳试验，目的是确定应力范围与失效前可施加的次数之间的关系。这些特定试验为脉动和轴向/扭转试验。最后，将进行体内动物试验，以确认我们的支架设计。这将允许使用 独特的组织内衬Peritec支架，以满足终末期肾病治疗中严重且不断增长的未满足需求。

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.