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Development and Preclinical Testing of the TORVAD Ventricular Assist System in Preparation for First in Human Implantation

TORVAD 心室辅助系统的开发和临床前测试，为首次人体植入做准备

基本信息

批准号：
9477771
负责人：
Jeffrey Robert Gohean
金额：
$ 99.91万
依托单位：
WINDMILL CARDIOVASCULAR SYSTEMS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-08-23 至 2021-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9477771
关键词：
Acute Address Animal Experiments Animal Model Blood Blood Tests Cardiac Output Ceramics Chronic Clinical Computer software Conduct Clinical Trials Data Data Reporting Development Device Designs Device Safety Devices Ensure Evaluation Event Failure Fatigue Feasibility Studies Generations Goals Guidelines Health Heart Hematology Hemolysis Hemorrhage Homeostasis Howard Temin Award Human In Vitro Incidence Individual Investigation Manufacturer Name Mechanics Medical Device Minor Molecular Weight Motor Neurologic Neurologic Dysfunctions Operative Surgical Procedures Output Patient-Focused Outcomes Patients Performance Pharmaceutical Preparations Phase Physicians Platelet Activation Preclinical Testing Preparation Procedures Process Pulsatile Flow Pump Recording of previous events Reporting Risk Running Safety Software Design Software Validation Speed Stroke Sturnus vulgaris System Technology Testing Thrombus Time Trauma Validation Ventricular Work aortic valve austin design experience experimental study first-in-human hemodynamics implantation improved in vitro testing in vivo performance tests pre-clinical preservation pressure prototype public health relevance research and development sensor success ventricular assist device verification and validation von Willebrand Factor

项目摘要

DESCRIPTION (provided by applicant): The TORVAD(tm) is a unique ventricular assist system that delivers low-shear, synchronous, pulsatile flow. Blood shear due to pumping is minimized by the relatively low speed of pistons supported by hydrodynamic bearings designed to maintain a fixed gap between the piston and torus walls. The TORVAD synchronizes with the heart to preserve aortic valve flow and maintains autoregulation of cardiac output by the Frank-Starling mechanism. The design of the TORVAD also allows for inherent determination of differential pump pressure, without additional sensors, which can be used to manage patient medications and pump flow rates. These advantages have been confirmed in preliminary studies. In vitro tests have demonstrated that the low-shear design preserves high-molecular-weight von Willebrand factor and results in significantly reduced hemolysis as compared to clinically available continuous flow devices. The TORVAD's hematological results are unmatched by any other ventricular assist device. In addition, synchronous hemodynamics have been demonstrated using acute and chronic animal models. These preliminary findings demonstrate that the TORVAD has the potential to reduce bleeding, thrombus formation, and strokes that are associated with the use of other ventricular assist devices. The goal of this project is to bridge the TORVAD from R&D to first-in-human clinical trials by conducting the verification and validation steps necessary to determine the safety of the TORVAD system and to apply for an Investigational Device Exemption (IDE) for an Early Feasibility Study. This will be accomplished as follows: 1) Use previous experience with prototypes to finalize the design, implement design controls, and perform risk analysis on the system; 2) Fabricate and assemble 35 systems for testing; 3) Perform subsystem verification testing; 4) Complete in vitro design evaluation and system performance testing to confirm device performance and reliability; 5) Conduct in vivo acute and chronic animal experiments to demonstrate device safety; and 6) Apply for an IDE for an early feasibility study.

描述（由申请人提供）：TORVAD（TM）是一种独特的心室辅助系统，可输送低剪切、同步、脉动流。由于泵送导致的血液剪切通过由流体动力轴承支撑的活塞的相对低的速度而最小化，该流体动力轴承被设计成在活塞和环面壁之间保持固定间隙。TORVAD通过Frank-Starling机制与心脏一起维持主动脉瓣血流并维持心输出量的自动调节。TORVAD的设计还允许在没有附加传感器的情况下固有地确定泵压差，这可用于管理患者药物和泵流速。这些优势已在初步研究中得到证实。体外试验表明，与临床可用的连续流装置相比，低剪切设计保留了高分子量血管性血友病因子，并导致溶血显著减少。TORVAD的血液学结果是任何其他心室辅助设备无法比拟的。此外，同步血流动力学已被证明使用急性和慢性动物模型。这些初步结果表明，TORVAD有可能减少与使用其他心室辅助器械相关的出血、血栓形成和卒中。该项目的目标是通过执行必要的验证和确认步骤，将TORVAD从研发过渡到首次人体临床试验，以确定TORVAD系统的安全性，并申请用于早期可行性研究的研究器械豁免（IDE）。这将通过以下方式完成：1）使用先前的原型经验来完成设计，实施设计控制，并对系统进行风险分析; 2）制造和组装35个系统进行测试; 3）进行子系统验证测试; 4）完成体外设计评价和系统性能测试，以确认器械性能和可靠性; 5）进行体内急性和慢性动物实验，以证明器械的安全性; 6）申请IDE进行早期可行性研究。