PEDIATRIC BLOOD PUMP DEVELOPMENT--PHASE II

这项工作的主题是开发一种机械循环系统 专门用于儿科护理的支持系统(MCSS)， 涵盖了从新生儿到幼儿的各种患者的需求。一个 关于目前批准用于这类设备的共同意见 病人是不成比例的大块头，而且总体上缺乏 与成人护理中使用的MCSS相关的技术创新。这个 本申请的基础是一系列成功的 在过去12个月中进行的体外和体内实验 Nimbus及其发展伙伴匹兹堡大学(UOP)， 这证明了他们的儿科血泵概念的合理性。 现在，在第二阶段，我们打算完成基本的设计和验证 该产品，并完成其设备就绪的主要部分 预期临床试验中的测试。 达到这些目标将验证儿科血泵的概念是 在IDE临床试验中进行安全性评估。这样的审判将是 第三阶段计划的主题，我们将寻求资金来完成 管理IDE设备的完整法规要求，完全制造 合格的硬件，确定组件可靠性级别，并进行 临床试验本身。 拟议的商业应用：Nimbus的新产品具有潜力 在美国和国外的所有医院进行商业应用， 进行新生儿-儿科心脏手术。

The subject of this work is development of a mechanical circulatory support system (MCSS) intended specifically for use in pediatric care, covering the needs of patients ranging from neonates to small children. A common opinion regarding devices currently approved for this class of patients is that they are disproportionately large, and in general, lack technical innovation associated with MCSSs used in adult care. The underpinnings for the present application are a series of successful in vitro and in vivo experiments conducted during the past 12 months by Nimbus and its development partner the University of Pittsburgh (UOP), which demonstrated the soundness of their pediatric blood pump concept. Now, in Phase II we intend to complete the basic design and validation of the product, and to accomplish a major portion of its device readiness testing in anticipation of clinical trials. Meeting these aims would verify that the pediatric blood pump concept is safe to be evaluated in IDE clinical trial. Such a trial would be the subject Of a Phase III program, wherein we would seek funding to complete the full regulatory requirements governing an IDE device, fabricate fully qualified hardware, determine component reliability levels, and conduct the clinical trial itself. PROPOSED COMMERCIAL APPLICATION: The new Nimbus product has potential commercial application in all hospitals, both in the U.S. and abroad, that perform neonatal-pediatric cardiac surgery.