Device for Treatment of Cardiac No-Option Patients

ABSTRACT Of the nearly million US patients suffering from myocardial infarction each year are poor candidates for CABG or PCI because of diffuse CAD multiple stents and failed CABG and are therefore considered andquot no optionandquot patients These patients suffer daily from severe angina shortness of breath fatigue and the like and are frequently untreatable by CABG or PCI which has been shown to have very poor outcomes under these conditions With no interventional or surgical option because of their poor arterial systems these patients are treated pharmacologically in an attempt to make them as comfortable as possible Absent a heart transplant the no option patient typically progresses to CHF The Company s technology is designed to provide the no option patient with an alternative that is not reliant on a repairable arterial system That is to leverage a staged approach for coronary retroperfusion with a novel venous pressure preconditioning VPP device Development of the VPP device has focused on overcoming limitations associated with coronary retroperfusion that have stemmed from abrupt increases in perfusion pressure leading to edema and hemorrhage of the myocardium Our approach avoids acutely raising the pressure in the coronary veins from venous mmHg to arterial values mmHg in a single step and instead regulates the pressure at an intermediate level between arterial and venous levels Current efforts from our group has demonstrated that intermediate elevations in venous pressure can arterialize venous segments and is a key requirement for preventing myocardial damage associated with venous retroperfusion at arterial pressures These findings re open the door for retroperfusion and hence can provide a therapy for no option patients through coronary venous bypass grafting CVBG Therefore the overall objective of this proposal is to validate the safety and efficacy of a VPP device that can arterialize coronary venous vessels to serve as a therapeutic bridge to CVBG Bench testing and refinement of the self expanding device supports the percutaneous delivery of the VPP which can increase the pulsatility as well as mean pressure under simulated coronary venous conditions both of which are primary stimulants for arterialization of veins Together our device and method pre arterialize the venous system for revascularization and provides a staged treatment for the no option ischemic heart NARRATIVE Approximately of the million patients that suffer heart attack per year in the US are poor candidates for bypass or coronary intervention and are considered andquot no optionandquot patients The overall objective of this proposal is to validate the safety and efficacy of a novel venous pressure preconditioning device that reduced ischemic injury and enable revascularization for the hearts of the no option patient