Development of the PediaFlow Pediatric Ventricular Assist Device

描述（由申请人提供）：本申请“PediaFlow”小儿心室辅助装置的开发”旨在解决广泛挑战领域（04），临床研究和特定挑战主题04-HD-102，小儿医疗器械的开发。该项目的重点是继续开发一种完全植入式、磁悬浮、小型化的儿科心室辅助装置（VAD）-PediaFlow -该装置将作为3- 20公斤儿童心力衰竭患者移植或恢复的桥梁，迄今为止，无法通过传统成人尺寸的心室辅助装置提供支持，而必须依靠试验用VAD装置或体外膜式氧合器（ECMO）技术，尽管它的并发症和死亡的重大风险。为此，我们开发了我们认为是世界上最小的磁悬浮（磁悬浮）血泵。由于我们的超临界（高于共振频率）转子动力技术和只有一个运动部件的无阀涡轮动力设计，PediaFlow非常小。由于我们使用磁悬浮技术、流线型单流道设计和计算机优化设计过程，PediaFlow VAD在我们前两个原型的临床前测试中已经证明了无与伦比的生物相容性。我们最近完成了第三个原型的设计和初步生产，该原型的大小约为AA电池的大小。该原型的持续生产、测试和验证（这是本文提出的工作重点）将使我们能够向FDA申请研究器械豁免（IDE）状态和我们的首次临床试验。为了实现这一目标，我们将通过体外和体内测试优化和冻结我们的第三个PediaFlow（PF 3）儿科VAD原型的设计，从而形成我们的临床版本的PediaFlow VAD设计。作为该过程的一部分，我们还将开发PediaFlow泵的流量估计和生理控制算法，以及调整我们的公司合作伙伴World Heart，Inc.开发的外部电子软件和相关配件，以用于我们的PediaFlow VAD系统。完成这些任务将最终产生一个完全集成的PediaFlow系统用于临床。 公共卫生相关性：本项目的目的是完成一个完全植入式磁悬浮婴儿和儿童左心室辅助装置的设计和验证。我们提出了一系列的实验室和动物研究，将证明我们的小儿心室辅助装置的上级生物相容性和血流动力学性能。这些研究的结果将导致设计冻结，预计将向FDA提交试验用器械豁免申请。

DESCRIPTION (provided by applicant): This application, "Development of the PediaFlow" Pediatric Ventricular Assist Device" is meant to address the Broad Challenge Area (04), Clinical Research, and specific Challenge Topic 04-HD-102, Development of Pediatric Medical Devices. The focus of the project is the continued development of a fully implantable, magnetically levitated, miniaturized pediatric ventricular assist device (VAD) - the PediaFlow - that will serve as bridge to transplant or bridge to recovery for the 3-20kg pediatric heart failure patients, whom, to date, are unable to be supported by conventional adult-sized ventricular assist devices and must rely instead on investigational VAD devices or extracorporeal membrane oxygenator (ECMO) technology despite its significant risk of complications and death. To that end, we have developed what we believe to be the world's smallest magnetically levitated (maglev) blood pump. The PediaFlow is exceptionally small, due to our supercritical (above resonance frequency) rotordynamic technology and valveless turbodynamic design with only one moving part. Because of our use of maglev technology, streamlined single-flowpath design, and computer- optimization design process, the PediaFlow VAD has already demonstrated unparalleled biocompatibility in pre-clinical testing of our first two prototypes. We have recently completed the design and initial production of our third prototype, which is approximately the size of a AA cell battery. Continued production, testing, and validation of this prototype, which is the focus of the work proposed herein, will bring us to the point of application to the FDA for Investigational Device Exemption (IDE) status and our first clinical trials. To achieve this goal, we will optimize and freeze the design of our third PediaFlow (PF3) pediatric VAD prototype through in-vitro and in-vivo testing, leading to our clinical version of the PediaFlow VAD design. As part of this process, we will also develop the flow estimation and physiologic control algorithm for the PediaFlow pump, as well as adapt the external electronics software and related accessories developed by our corporate partner, World Heart, Inc, for use in our PediaFlow VAD system. Accomplishing these tasks will ultimately yield a fully integrated PediaFlow system for clinical use. PUBLIC HEALTH RELEVANCE: The aim of this project is to complete the design and validation of a fully implantable, magnetically levitated left ventricular assist device for infants and children. We propose a series of laboratory and animal studies which will demonstrate the superior biocompatibility and hemodynamic performance of our pediatric ventricular assist device. The results of these studies will lead to a design freeze in anticipation of submitting an application to the FDA for Investigational Device Exemption.