Onocor LLC — Department of Health and Human Services STTR Phase I: NHLBI

Description

During the past decade there has been an exponential growth in the numberscope and complexity of catheter based interventions for structural heart diseaseTranscatheter aortic valve replacementTAVRendovascular aneurysm repairEVARvena caval filters and intracardiac defect closure are all well developed and growing treatment strategiesThe recent FDA approval of left atrial appendageLAAocclusion for atrial fibrillation and patent foramen ovalePFOclosure for cryptogenic strokehas opened the door for the high volume application of these proceduresThe trend shows signs of acceleration with ever more complex therapeutic options on the horizon including devices for transcatheter mitral replacementTMVRCurrently remedial surgical procedures are required to retrieve misplaced devicesA transcatheter retrieval system would represent a major advance that would spare patients the pain of remedial surgical procedures and provide asafety netthat promotes the use of these less invasive procedures and expands the number of patients who benefit from themOur group has begun development of such retrieval systemThe system consists ofcustomized coaxial catheter for introduction of the system and recovery of the target implanta novel nitinol wire woven basket designed to envelopecompress and retrieve the target implantmechanical advantage system for steady application of the withdraw force andmanipulation tools to aid in orienting the target implantIn preliminary work we have demonstrated the effectiveness of the basket in compressing large stentsaortic valve framesaortic aneurysm stentsThe feasibility of introducing early prototypes into the heart and withdrawing them in animal models has also been shownSince the last submission of this applicationstudies of initial prototypes have identified weakness in the design which have been improved significantlyThe goal of the current Phase I STTR proposal is to strengthen the existing proof of principle data and justify the further optimization of the design and implementation of the Onocor Retrieval system A growing number of cardiovascular diseases are now treatable by transcatheter therapyThese procedures are complex and prone to device misplacementeven by experienced operatorsCurrently remedial surgical procedures are required to retrieve misplaced devicesA transcatheter retrieval system would be a major advance that would spare patients pain and provide asafety netthat promotes the use of less invasive proceduresOur group has begun development of such retrieval systemThis Grant will aid in the development process