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AUSTIN, TX, United States

Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 100.14K | Year: 2013

DESCRIPTION (provided by applicant): Heart failure (HF) is a major health problem in the US and worldwide. Over 100,000 people in the US are diagnosed with end stage HF annually. Heart transplantation is performed in only 2% of these cases due to lack of available donor hearts. Mechanical left ventricular assist devices (LVADs, a type of artificial heart) can allow patients with severe HF to live a productive and relatively comfortable life if cardiac transplantation is not possible for them. Our goal is toimprove the treatment of severe heart failure by developing and commercializing the TORVAD system, which is a valveless, pulsatile LVAD. The currently available LVADs use rotary, turbine-like pumps that support the circulatory system with a steady, pulse-free stream of blood, which typically means the patient no longer has a pulse. It is then difficult or impossible to measure their blood pressure and also difficult o optimize medications for their heart failure. Additionally this pulseless blood flow induces abnormal blood vessel formation in the gut and brain that can lead to serious bleeding complications. The focus of this project is to experimentally test the clinical readiness of our pulsatile LVAD and develop unique control features that will significantly improve the care of patients with heart failure. The specific design will feature a dual piston, pulsatile pump that activates simultaneously with the native heart activity, senses blood pressure, and permits remote patient monitoring, to produce an improved patient sense of well-being and safety with significantly reduced complications. Previously, in collaboration with the University of Texas Health Science Center - Houston, a series of bench top and animal studies successfully demonstrated the feasibility and superiority of synchronized pulsatile flow as compared to continuous flow support. In Phase I we will (1) Characterize hydraulic pump performance and assess potential for blood damage by the pump in bench top tests; (2) Optimize the pump control module and means for remote patient monitoring; (3) Develop blood pressure sensing capability by the pump and (4) Conduct three short-term animal experiments to demonstrate basic hydraulic performance, biocompatibility, and synchronization with the heart cycle including automatic adjustments to pump function during irregular heart rhythms and major changes in heart rate. In Phase II we will demonstrate system safety and endurance, and will (1) Conduct accelerated durability tests on critical pump subsystems; (2) Perform 180-day durability tests on two pumping systems operating in bench top simulated circulatory loops; (3) Perform five short-term animal experiments to demonstrate optimal surgical implantation and de-airing procedures, optimal hemodynamicperformance, ECG sensing and synchronicity, suction detection, pump auto-regulation, pressure sensing and control; and (4) Conduct three 30-day chronic animal tests to assess physiological performance, biocompatibility, device safety, durability, blood cell damage, and risk of stroke. We believe that our technology has the potential to improve patient quality of life while minimizing complications compared to currently available LVADs. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: We are developing an innovative blood pumping technology with the potential to advance the clinical treatment of severe heart failure, a condition that is experienced by over 100,000 US patients. We aim to conclusively demonstrate that our TORVAD system restores optimal blood flow, reduces complications, and possesses the needed endurance to effectively treat heart failure and potentially increase cardiac recovery rates, promoting the use of implantable blood pumps to treat earlier stages of the disease.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 999.38K | Year: 2016

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 TORVADandapos 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 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 Exemption IDE for an Early Feasibility Study This will be accomplished as follows Use previous experience with prototypes to finalize the design implement design controls and perform risk analysis on the system Fabricate and assemble systems for testing Perform subsystem verification testing Complete in vitro design evaluation and system performance testing to confirm device performance and reliability Conduct in vivo acute and chronic animal experiments to demonstrate device safety and Apply for an IDE for an early feasibility study PUBLIC HEALTH RELEVANCE Due to the lack of donor hearts an ever growing number of patients receive a ventricular assist device each year The TORVAD tm has 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 technology This provides the valveless pulsatile flow TORVAD with the potential to improve patient management and reduce incidence of bleeding neurological dysfunction and strokes End of Abstract


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase II | Award Amount: 745.71K | Year: 2014

DESCRIPTION (provided by applicant): Heart failure (HF) is a major health problem in the US and worldwide. Over 100,000 people in the US are diagnosed with end stage HF annually. Heart transplantation is performed in only 2% of these cases due to lack of available donor hearts. Mechanical left ventricular assist devices (LVADs, a type of artificial heart) can allow patients with severe HF to live a productive and relatively comfortable life if cardiac transplantation is not possible for them. Our goal is toimprove the treatment of severe heart failure by developing and commercializing the TORVAD system, which is a valveless, pulsatile LVAD. The currently available LVADs use rotary, turbine-like pumps that support the circulatory system with a steady, pulse-free stream of blood, which typically means the patient no longer has a pulse. It is then difficult or impossible to measure their blood pressure and also difficult o optimize medications for their heart failure. Additionally this pulseless blood flow ind


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 997.49K | Year: 2015

DESCRIPTION provided by applicant The goal of this project is to develop a miniaturized pediatric version of the TORVADTM a unique ventricular assist system that delivers low shear synchronous pulsatile flow using controlled piston motion within a toroidal chamber Low shear is achieved by the relatively low piston speed in conjunction with localized hydrodynamic bearings that maintain bulk piston torus gap at a fixed distance 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 patientandapos s medications and flow rates These advantages have been confirmed in preliminary studies with an adult TORVAD 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 a continuous flow device In addition hemodynamic compatibility has been demonstrated using acute and chronic animal models The TORVADandapos s hematological results are unmatched by any other ventricular assist device 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 develop a pediatric version of the TORVAD to be used in patients with body surface area BSA between and m The feasibility of a pediatric TORVAD has been demonstrated through the development and testing of the adult version where computational models for hemodynamics heat transfer motor design fluid dynamics and magnetostatics were used to design fabricate and verify performance with the assembled pump For this work we will Use the established computational design methodology to miniaturize the device for pediatric patients with a BSA between and m Fabricate five devices and perform design verification Conduct in vitro experiments to assess hemolysis high molecular weight von Willebrand factor preservation and platelet activation and Perform three acute animal experiments to assess implantability hemodynamic performance and synchronization PUBLIC HEALTH RELEVANCE Hundreds of children die each year waiting for a donor heart Options for mechanical circulatory support in pediatrics are limited and the development of new devices is in progress to address this unmet clinical need The pediatric TORVAD tm shows promise to address challenges associated with ventricular assist devices including the incidence of bleeding neurological dysfunction and strokes its success will provide beneficial patient outcomes and allow for more widespread use of ventricular assist devices in pediatric patients


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