Performance Evaluation of MiTiHeart LVAD

描述（由申请人提供）： 拟议竞争延续的总体目标是开发并将满足FDA IDE申请要求所需的要素纳入MiTiHeart LVAD。为了支持这一目标，并根据FDA的初步沟通，已确定需要为MiTiHeart LVAD添加经确认的电子控制器和电源系统沿着额外的体外和体内试验，以支持IDE申请。MiTiHeart LVAD是在之前的SBIR赠款和公司基金下开发的，是一种小型无血栓旋转泵，具有磁悬浮和冗余流体动力推力轴承系统。当前设计规定，所有血液接触表面均由TI-6AI-4V合金制成，并涂有创新的全氢化类金刚石碳（DLC）涂层。将肝素化有机膜外涂层应用于所有旋转DLC涂层血液接触表面。疏水性DLC涂层和亲水性有机涂层的组合提供了降低剪切应力和最小化血小板活化的创新方法，从而降低溶血和血栓形成的可能性。拟议的性能测试包括体外溶血测试、体内小牛动物测试和体外长期耐久性测试。每次试验后，将检查所有LVAD组件是否有血栓形成或涂层降解迹象，并在进行下一次试验前进行必要的修改。针对拟议的SBIR竞争延续计划，计划了以下具体目标：（1）开发MiTiHeart LVAD的控制器和电源系统，（2）制造用于性能评价的血泵，（3）进行体外溶血试验，（4）使用小牛模型进行体内动物试验，以及（5）进行体外性能和耐久性试验。作为该项目的结果，在提交IDE申请之前，将准备好一个可靠且全面表征的LVAD（带经皮控制器和电源系统），以进行所需的额外临床前试验。在第II阶段的商业化工作中，本研究开发的技术将转移给MiTiHeart Corporation（MiTi的子公司），该子公司旨在制造和销售独特的血泵，用于目前脉动式器械无法提供服务的中小型成人心力衰竭患者的目的地治疗。

DESCRIPTION (provided by applicant): The overall objective of the proposed Competing Continuation is to develop and incorporate into the MiTiHeart LVAD those elements necessary to meet the requirements for FDA IDE application. In support of this goal and based on initial FDA communications, it has been determined that the addition of a validated electronic controller and power supply system to the MiTiHeart LVAD along with additional in vitro and in vivo testing are needed to support the IDE application. The MiTiHeart LVAD, which has been developed under previous SBIR Grants and company funds, is a small non-thrombogenic rotary pump with magnetic levitation and a redundant hydrodynamic thrust bearing system. The current design specifies that all blood-contacting surfaces be manufactured from TI-6AI-4V alloy and coated with an innovative fully hydrogenated diamond like carbon (DLC) coating. A heparinized organic film overcoat is applied to all rotating DLC coated blood-contacting surfaces. The combination of hydrophobic DLC coating and hydrophilic organic coating provides an innovative means to reduce the shear stresses and minimize platelet activation, thereby reducing the potential for hemolysis and thrombosis. The proposed performance tests include in vitro hemolysis tests, in vivo bovine calf animal testing, and in vitro long-term durability tests. All LVAD components will be inspected following each test for indications of thrombus formation or coating degradation and will be modified if necessary before embarking on the next test. The following Specific Aims are planned for the proposed SBIR Competing Continuation program: (1) Develop the controller and power supply system for the MiTiHeart LVAD, (2) Manufacture blood pumps for performance evaluations, (3) Conduct in vitro hemolysis testing, (4) Conduct in vivo animal testing using a bovine calf model, and (5) Perform in vitro performance and durability testing. As a result of this program a reliable and thoroughly characterized LVAD with percutaneous controller and power supply system will be readied for additional preclinical testing required prior to submission of the IDE application. In the commercialization efforts of Phase II, the technology developed under this study will be transferred to MiTiHeart Corporation, a subsidiary MiTi, established to manufacture and market unique blood pumps for use as destination therapy for adult heart failure patients of small to medium frame that are not being served by present pulsatile devices.