Perfusion Solutions, Inc. — Department of Health and Human Services SBIR Phase I: R

Description

LVAD use is increasing for both bridge and destination applicationsbut the need for right ventricular assist is apparenteven in patients selected to avoid this complicationThese patients usually receive a temporary right ventricular assist deviceRVADwith a short livedexternal pump when the need becomes apparentalthough the survival rate is superior with a pre operatively planned biventricular implantThe difficulty is a paucity of good implantable systems for RVAD useExisting implantable LVAD pumps adapted to this use bring with them significant compromises for right sided usePSI has created a new design of highspecific speedpump well suited to the high flow but low pressure conditions of the pulmonary circulationThe true axial flow pump would be used as an interposition implant in the pulmonary arteryThe design presents minimal blockage to flow to potentiate deposition or impose parasitic load on the ventricle if the pump stopsA unique bearing creates minimum shear stresses on bloodhas low residence timesand works well over a very wide speed rangePTFE copolymer blood contacting surfaces are proposeda class of material with a record of success in the pulmonary circulationPhase I feasibility issues include demonstrating adequate performance with low static pressure droplow bench test hemolysisappropriate calculated shear stress fields with no stagnation separation zones to activate platelets and depositionand potential for high durabilityWith demonstration of feasibility during phase Iphase II will proceed to implant studies to confirm performance and clot free behavior Narrative Left ventricular assist devicesLVADshave proven to be a lifesaving treatment for end stage heart failureHowevermany patients are excluded from this treatment because of obviously inadequate right ventricular functionwhile some LVAD recipients die or have poor quality of life because their right side function proves to be poorer than expectedToday only temporary right side assist pumps are availablewhich is inadequate for large number as of patientsLVAD pumps have been adapted out of necessity for right side usebut this comes with many compromisesThis project will demonstrate a new implantable pump uniquely suitable for right side use for these patients