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

DESCRIPTIONprovided by applicantThe TORVAD tmis a unique ventricular assist system that delivers low shearsynchronouspulsatile flowBlood 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 wallsThe TORVAD synchronizes with the heart to preserve aortic valve flow and maintains autoregulation of cardiac output by the Frank Starling mechanismThe design of the TORVAD also allows for inherent determination of differential pump pressurewithout additional sensorswhich can be used to manage patient medications and pump flow ratesThese advantages have been confirmed in preliminary studiesIn 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 devicesThe TORVADandapos s hematological results are unmatched by any other ventricular assist deviceIn additionsynchronous hemodynamics have been demonstrated using acute and chronic animal modelsThese preliminary findings demonstrate that the TORVAD has the potential to reduce bleedingthrombus formationand strokes that are associated with the use of other ventricular assist devicesThe goal of this project is to bridge the TORVAD from Randamp 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 ExemptionIDEfor an Early Feasibility StudyThis will be accomplished as followsUse previous experience with prototypes to finalize the designimplement design controlsand perform risk analysis on the systemFabricate and assemblesystems for testingPerform subsystem verification testingComplete in vitro design evaluation and system performance testing to confirm device performance and reliabilityConduct in vivo acute and chronic animal experiments to demonstrate device safetyandApply for an IDE for an early feasibility study PUBLIC HEALTH RELEVANCEDue to the lack of donor heartsan ever growing number of patients receive a ventricular assist device each yearThe TORVAD tmhas the potential to address common complications associated with existing ventricular assist devices due to reduced blood trauma made possible by a unique low shear piston pumping technologyThis provides the valveless pulsatile flow TORVAD with the potential to improve patient management and reduce incidence of bleedingneurological dysfunctionand strokesEnd of Abstract