IGF::OT::IGF Topic 090, Phase II, Devices to Close Ductus Arteriosus in Premature Infants IGF::OT::IGF

总结 具有血流动力学显著性动脉导管未闭的早产儿死亡率和发病率显著增加。微创、基于导管的治疗策略将是有吸引力的。 项目目标 该项目的目标是开发一种植入式动脉导管未闭闭合装置，通过早产儿的外周血管安全输送。首先，原型将在动物身上开发和测试，最终临床级设备将在NIH进行临床测试的监管开发。 我们鼓励报价人在其建议书中包括具体的里程碑，沿着详细的研究和开发计划、风险分析以及第一阶段和第二阶段的应急计划。 人们认识到，可用的动物模型可能与器械的预期人体体内几何形状不匹配。 建议报价人计划前往马里兰州贝塞斯达的NHLBI，并计划在项目启动时、项目中期和项目完成时举行会议，以确定需要进行哪些迭代。

Summary Premature infants with hemodynamically significant patent ductus arteriosus suffer increased mortality and significant morbidity. A minimally invasive, catheter based treatment strategy would be attractive. Project Goals The goal of the project is to develop an implantable patent ductus arteriosus closure device to be safely delivered through the peripheral vasculature of a premature infant. First, a prototype would be developed and tested in animals, and ultimately a clinical-grade device would undergo regulatory development for clinical testing at NIH. Offerors are encouraged to include concrete milestones in their proposals, along with detailed research and development plans, risk analysis, and contingency plans, both for Phase I and Phase II. It is recognized that available animal models may not match the desired human in vivo geometry of the device. Offerors are advised to plan for travel to NHLBI in Bethesda Maryland, and are expected to plan meetings at project initiation, mid-project to determine what iteration is necessary, and at project completion.