IGF::OT::IGF SBIR Topic 079 Phase I- Bioabsorbable Stents for Pediatric Pulmonary

IGF::OT::IGF SBIR 主题 079 I 期 - 用于儿科肺的生物可吸收支架

• 批准号: 8757438
• 负责人: MARIA PALASIS
• 金额: $ 20万
• 依托单位: LYRA THERAPEUTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-27 至 2014-03-26
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8757438
• 关键词: Accounting; Aortic coarctation; Biological; Cardiovascular system; Catheters; Childhood; Contractor; Data; Development; Device Designs; Devices; Human; Imagery; Inflammatory; Laboratories; Lung; Mechanics; Morphology; National Heart, Lung, and Blood Institute; Performance; Phase; Protocols documentation; Pulmonary artery structure; Research; Safety; Small Business Innovation Research Grant; Stents; System; Techniques; artery stenosis; base; constriction; design; implantation; in vivo; prototype; research study; restenosis

The contractor shall deliver transcatheter stents using conventional interventional cardiovascular techniques includingguiding catheters or sheaths, translesional guidewires, and balloon-expandable or self-expanding delivery systems.During Phase I the contractor shall focus on mechanical and biological performance of the proposed biodegradablestents in the intended use for pulmonary artery stenosis and aortic coarctation, taking into account mechanicalstrength required for the application; geometry of the access vessels and geometry and morphology of targetvessels including tapering and branching; strategies to avoid inflammatory restenosis or constriction; and delivery,implantation, and visualization strategies. At the conclusion of Phase I, a candidate device design shall be selected forclinical development based on in vivo performance of a mature prototype resembling a final design. At the conclusionof Phase II the contractor shall obtain an investigational device exemption (IDE), and a supply of devices provided, fora first-in-human research protocol, involving at least 10 subjects, to be performed by the sponsoring NHLBI laboratory.The contractor shall perform or obtain safety-related in vivo experiments and data to support the IDE.

承包商应使用传统的介入心血管技术输送经导管支架，包括引导导管或护套、经病变导丝以及球囊扩张或自扩张输送系统。在第一阶段，承包商应重点关注拟议的可生物降解支架在预期用途中的机械和生物性能对于肺动脉狭窄和主动脉缩窄，考虑到应用所需的机械强度；通路血管的几何形状以及目标血管的几何形状和形态，包括逐渐变细和分支；避免炎症再狭窄或收缩的策略；以及递送、植入和可视化策略。在第一阶段结束时，应根据类似于最终设计的成熟原型的体内性能选择候选设备设计用于临床开发。在第二阶段结束时，承包商应获得研究设备豁免 (IDE)，并为首次人体研究方案提供设备供应，该方案涉及至少 10 名受试者，由主办的 NHLBI 实验室执行。承包商应执行或获取安全相关的体内实验和数据以支持 IDE。