Pre-Clinical Development & Testing of the CorWave Membrane LVAD.

The CorWave LVAD employs a novel wave membrane technology to generate low shear blood propulsion, synchronized to the native left ventricle. Here, we report the results of preclinical testing of hemodynamics, hemocompatibility, and durability for the CorWave LVAD. The pump motor, membrane, blood flow path, magnetics, and mechanical components were designed using extensive computational simulations, then rigorously tested. Durability was tested at the material, component, pump, and system level with both real-time and, when feasible, accelerated fatigue tests. Hemocompatibility was assessed in vitro and in acute (<6 hr) and chronic (up to 90 day) implants in sheep, including "thrombo-provocative" tests in which anticoagulation was reversed 10 mins after pump implant and pump output was intentionally kept to 1-3 LPM. An adaptive algorithm to automatically adjust to changes in hemodynamics was developed and tested with In vitro mock circulation loops (MCLs), acute implants in sheep with induced heart failure or RV-bypass, and chronic implants in healthy sheep. These studies were used to evaluate and improve the pump algorithm for synchronization with the LV, arrhythmia detection, suction detection and response, and responses to hemodynamic changes. Material testing and simulations predict multi-decade durability of the wave membrane. Multiple prototype pumps have completed 2-year durability tests. 12 life cycle test stands have been built and validated to commence multi-year, real-time durability testing of the clinical version of the LVAD, currently in production. Hemodynamic testing demonstrated successful LV synchronization to 95% of the native LV contractions, while the algorithm successfully detected arrhythmias, suction events, heart rate changes, and after-load changes. Responses to suction events and changes in pre-load have been revised and are undergoing confirmatory testing. Low hemolysis and preservation of von Willebrand factor activity were demonstrated in chronic implants. Thrombo-provocative studies demonstrated successful design modifications to eliminate thrombus on vulnerable pump surfaces. The CorWave LVAD has undergone extensive design efforts and a comprehensive pre-clinical test regime to establish the clinical design will have the required durability, hemocompatibility, and adaptability to commence clinical trials. [ABSTRACT FROM AUTHOR]