Novel Collagen-Based Peripheral Endoprosthesis

描述(逐字摘自申请者摘要)：尽管 接受经皮腔内血管成形术(PTA)和血管内成形术 支架植入治疗外周动脉粥样硬化病变的患者，这些 这些技术存在一些缺陷，限制了它们在临床上的整体成功。 高再狭窄率仍然是PTA的主要并发症和 血管内支架植入手术。这项研究的总体目标是 一种新型胶原基人工骨(CBE)的设计、开发和体内试验 以降低PTA术后再狭窄率。 在第一阶段的研究中，我们设计并开发了一个CBE原型 它可以通过标准的经皮腔内给药 干预技术。与CBE原型相比，CBE原型的通畅率更高 以ePTFE血管移植物为基础的犬股骨假体原型 动脉模型。在第二阶段，我们将进一步完善CBE的设计， 并评估CBE在动脉粥样硬化动物体内的表现 模特。待第二阶段研究完成后，我们会继续进行第三阶段研究。 计划并积极开展CBE的临床试验和商业化 设备。 建议的商业应用： 仅在1995年，美国就有超过15万例经皮腔内血管成形术(PTA)手术用于治疗周围动脉粥样硬化病变。晚期再狭窄的发生通常会导致再次干预，从而导致患者护理总成本的显着增加。如果拟议的假体装置运行良好，5%的再狭窄率可以转化为每年节省超过1亿美元的相关医疗费用。

DESCRIPTION (Verbatim from the Applicant's Abstract): Despite the wide acceptance of percutaneous transluminal angioplasty (PTA) and intravascular stenting for treating patients with peripheral atherosclerotic lesions, these techniques suffer some drawbacks, which, limit their overall clinical success. A high rate of restenosis remains the major complication of PTA and intravascular stenting procedures. The overall goal of this research is to design, develop and test in vivo a novel collagen-based endoprosthesis (CBE) for reducing the rate of post-PTA restenosis. In the phase I investigation, we have designed and developed a CBE prototype that can be reliably delivered by standard transluminal percutaneous intervention techniques. The CBE prototype had a superior patency rate compared to an ePTFE vascular graft-based endoprosthesis prototype in a canine femoral artery model. In the phase II, we will further improve the design of the CBE, and evaluate the in vivo performance of the CBE in an atherosclerotic animal model. Upon completion of the phase II research, we will continue the phase III program and actively pursue clinical trials and commercialization of the CBE device. PROPOSED COMMERCIAL APPLICATION: There were more than 150,000 percutaneous transluminal angioplasty (PTA) procedures performed to treat patients with peripheral atherosclerotic lesions in the U.S. in 1995 alone. The occurrence of late restenosis typically lead to reinterventions that result in a significant increase of the total costs of patient care. If the proposed endoprosthesis device functions well, a 5% reduction of the restenosis rate can be translated into a savings of more than $100 million dollars a year in the associated healthcare costs.