CardioPort to Enable Intracardiac Beating Heart and Minimally Invasive Open Heart Surgery

DESCRIPTIONprovided by applicantThe goal of this Fast Track STTR project is to develop a novel CardioPortTM surgical device that will enable minimally invasive beating heart repair without use of cardiopulmonary bypassCPBThere is a critical unmet need for new instruments to improve the surgical repair of heart defects in childrenCurrent best surgical practices involve either open heart surgery with CPBwhich has a risk for serious adverse eventsor trans catheter procedures with large bulky devices that require a rim of tissue for stabilityand have a risk of late erosion into nearby structuresThis proposal is submitted in response to PAR"Safe and Effective Instruments and Devices for Use in Neonatal and Pediatric Care Settings " CardioPortTM is a novel cardiac instrumentation port that will improve visualization and cardiac repair capabilitiesand that is small enough to be used in trans cardiac
procedures in infants and children of all agesThe first generation prototype enables trans cardiac insertion but visualization of the surgical repair site requires use of an endoscope and camerawhich are heavy and can collide with endoscopic surgical tools used for repairThereforethe objective of this project is to integrate a camera and light source to produce a more ergonomically advanced instrumentand collect preclinical testing data to support human clinical evaluationPhase IAim Iis to optimize the CardioPortTM imaging system by optimizing the camera positionlight source and optical bulb configuration within the CardioPortTM envelope to maximize field of viewprovide uniform illuminationand minimize image distortionThe prototype will be tested in a well characterized benchtop ex vivo porcine cardiac modelThe key milestone from Phase I will be demonstration that the novel visualization system provides high resolution imaging with a field of view that includes the point of contact between the target tissue and the optical bulband a view of the instrument tip emerging from the channelPhase IIAim IIis to integrate the optimized visualization system from Phase I with the current instrument channel and flush system to create a fully functional smallermore ergonomicand light weight CardioPortTM prototypeThe instrument channel suction flush system will be optimized to remove debris and aira seal will be added to separate the fluidic and electrical systemsand the resulting prototype will be evaluated in a wellcharacterized ex vivo pig heart bench top modelPhase IIAim IIis to conduct pre clinical animal tests of the use of the integrated functional CardioPortTM prototype to close experimental atrial septal defectsTesting will include a non GLP acute and survival pilot studya GLP acute studyand a GLP chronic study withmonths of follow upHistological analysis will assess systemic embolieffective closure of the defectand healing of the heart tissue after insertion and removal of the
portSuccessful completion of this project will result in GLP testing data that that will supportK filing with the FDA