Commercialization of a Simple Automatic Perfusion System for ECPR

DESCRIPTIONprovided by applicantThe use of ECMO in conjunction with CPRa technique known as "ECPR"has been shown to reduce central nervous systemCNSdamageimprove brain function after recoveryand result in survival to hospitaldischarge rates up toA limiting factor for widespread adoption of ECPR is the need for a simple automatic perfusion system that is inherently safeand provides full support with minimal operator interventionDeveloped under SBIR fundingHLMCs patented technologies have been combined to form a compacthighly portablesafe and simple to use automatic perfusion systemAPSThis device will lower the barriers for implementation of emergent ECPR and facilitate expanded use of these procedures resulting in improved outcomes for refractory cardiac arrestThe APS system is also envisioned as a tool for salvaging donor organs after cardiac deathDCDThe user requirements for DCD support and ECPR are equivalentallowing broader application of the APS in the expanding field of extracorporeal supportIn Phase I and IIa prototype was developed for use in bench and animal testing and customer evaluationsIn vivo studies demonstrated restoration of cardiac function with ECPR afterminutes of untreated ventricular fibrillationAdditional studies with controlled and uncontrolled DCD animal models confirmed device functionality and demonstrated conditioning of organs to transplant status following extended periods of warm ischemia up tominutesParamedical personnel were trained on the use of MCsystemand assisted in animal studies to evaluate the usability of the systemThe goal of this Phase IIb NHLBI Bridge application is to advance the simple automatic perfusion system developed in Phase I II to a commercial product for ECPRWe will capture critical feedback from users and consolidate electronics to improve safety and usabilityThe system will undergo complete verification and validation testing to prepare for regulatory submissionIn vivo studies will be performed to assess device functionality and durabilityAt the end of Phase IIb we will have a highly integrated cardio pulmonary support system for use in ECPR with fully automated regulation of flowoxygenCOand temperature to support "controlled reperfusion" strategieswhile providing stableauto regulated perfusionWe anticipate this APS device will lower the barriers for implementation of emergent ECPRand will result in expanded acceptance of these procedures resulting in greatly improved ECPR outcomes and greater availability of donor organs if resuscitation is not possible