UNANDUP, LLC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

Arrhythmias are due to irregular contractions and disorganized electrical signals within the heart and are a leading cause of death in the United StatesUSVentricular tachycardia and ventricular fibrillation are the most serious arrhythmias and are associated withk annual US deathsIn comparisonatrial fibrillationAFimpactsM Americansmaking it the most common arrhythmiaWith nearlyk annual US hospitalizations andk annual US deathsAF is associated with the highest medical costswhich are projected to exceed $B byFirst line AF therapies rely on pharmaceuticals to prevent blood clots and to restore proper rhythmWhen these approaches failcatheter ablation is an optionFor this procedureelectrical currentsor coolantsare directed to the catheter s tip to ablate those tissues disrupting normal electrical signalsCatheter ablation is an effective and increasingly used therapywith more thanM procedures performed betweenandHoweverstandard methods are complex and expose electrophysiologists to x raysBecause manually deflectable catheters rely on complex tension wire designs that are operated from a meter awayerrors accumulate in the transmission of forces and torquesAs a resultprecise catheter navigation and heartwall contact are challengingwhich can result in injury and AF recurrenceobserved inof those treatedRobotic platforms attempt to address manual ablation catheter deficienciesStandard robotic systems manipulate traditional manual catheters and place the electrophysiologist outside the x ray fieldHoweverthe technology s learning curve is highcatheter tip control is unimprovedand systems are expensiveMagnetbased robotic systems improve upon standard robotic systems by using magnetic fields to apply forces and torques directly to magnet tipped catheterswhich simplifies the cathetersThe result is a technology that provides improved navigation and better heart wall contactHowevermagnet based systems are impractically largevery expensivehard to installand difficult to usein addition to requiring a new c arm and magnetic shielding for the roomFor these reasonsbroad adoption of all AF robotic solutions has been slowAs opposed to expending energy in fighting the catheter s restoring forcethe proposed technology redesigns the catheter so that better catheter navigation and heart wall contact are accomplished using a system whose magnetic field and mass areX andX smallerrespectivelythan previously possibleThe result is an affordable technology thatprovides better catheter tip control and heart wall contactoffers an open catheter lumen for electrical leads and irrigationanddoes not require custom c arms and room constructionThe team reflects commercially successful magneticsroboticsand electrophysiology expertsThe Phase I effort focuses on proof of concept of the platformThe aims includebuilding the prototype magnet systembuilding catheters and advancerandevaluating the system s performance in beating heart phantomsAn FDA pre submission meeting will be conducted in advance of the Phase II proposal Arrhythmias represent a major cause of mortalitywhere ventricular fibrillation and ventricular tachycardia are associated withannual deaths in the United StatesUSand atrial fibrillationAFwhich affects nearly six million Americansis associated withannual deathsAs stated in theHRS EHRA ECAS APHRS SOLAECE Expert Consensus Statementcatheter ablation is an effective treatment optionhowevercontrol of the catheter requires considerable skillcan be impreciseand can result in variable heart wall contact whichtogetherincrease the likelihood of injury and arrhythmia recurrenceFor this Phase I SBIR applicationUNandamp UPshort forUnmet Needs and Underserved Populationswill demonstrate proof of concept of its patent pending magnet based electrophysiology robotic platform that provides superior ablative tip control against the heart wall and overcomes historical limitations related to usabilityresponsivenesscosteffectivenessand integrability