IMMEDIATE FIT USING INNOVATIVE TECHNOLOGY TRANSTIBIAL PROSTHESIS

 描述（由申请人提供）：iFIT Prosthetics，LLC（r）及其创始人的目标是创建并商业化一种模块化、即时适配、完全可调的经胫骨假体系统，该系统适用于大规模生产，使用高强度聚合物材料注塑成型，成本仅为传统假体的一小部分。这一目标已经实现，现在IIB阶段竞争性更新的目标是：i）完成经胫骨窝其余尺寸的注塑模具制造，以制造适合大多数截肢者的全系列经胫骨假体，ii）开发工艺和制造程序，以符合联邦CMS耐用医疗设备法规和FDA器械法规，iii）完成所有部件的国际标准（ISO 10328）耐久性测试，iv）为经股截肢者开发类似器械，以及v）对我们的器械和传统制造的假体进行更严格的有效性比较研究。最终的设计可以安装到截肢者的残肢只使用几个手持工具。我们的设备舒适、重量轻、功能强大，并且可以在患者身上进行对齐。该系统与大量市售的假足和硅胶销悬挂系统兼容。我们与Advanced Design Concepts（ADC）及其工程团队的合作在开发该产品方面取得了巨大成功。本研究的主要商业利益iFIT Prosthetics，LLC（r）已做好充分准备，以实现IIB期两年竞争性续约的目标。这种美国制造的、创新的、以消费者为中心的、具有成本效益的替代目前假肢制造状况的替代品的商业化，为增加获得假肢装置的机会和改善国内外越来越多的经胫骨和经股骨截肢者的生活质量带来了巨大的希望。

 DESCRIPTION (provided by applicant): The goal of iFIT Prosthetics, LLC(r) and its founder was to create and commercialize a modular, immediate fit, fully adjustable, transtibial prosthesis system suitable for mass production using high strength polymer materials that are injection molded at a fraction of the cost of conventionally made prostheses. This goal was achieved and now the aims of this Phase IIB competitive renewal are to; i) complete injection mold manufacture for the remaining sizes of transtibial sockets to make a full line of transtibial prostheses to fit most amputees, ii) develop processes and manufacturing procedures to comply with federal CMS Durable Medical Equipment regulations and FDA Device regulations, iii) complete international standards (ISO 10328) durability testing for all components, iv) develop similar devices for transfemoral amputees, and v) conduct a more rigorous comparative effectiveness study between our devices and conventionally manufactured prostheses. The final design can be fit onto the amputee's residual limb using only a few hand-held tools. Our device is comfortable, light in weight, highly functional, and can be aligned while remaining on the patient. This system is compatible with a large number of commercially available prosthetic feet and silicone pin suspension systems. Our collaboration with Advanced Design Concepts (ADC) and their engineering team has been highly successful in developing this product. The principal business interest in this study iFIT Prosthetics, LLC(r) is well poised to carry out the aims of ths Phase IIB two-year competitive renewal. Commercialization of this American-made, innovative, consumer-centered, cost-effective alternative to the current state of prosthetic fabrication holds great promise to increase access to prosthetic devices and to improve the quality of life for the large and growing number of persons with transtibial and transfemoral amputations domestically and internationally.