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

Description

Project SummaryEach yearnearlyinfants in the United States are born with a complex congenital heart disease that requires surgical intervention within the first year of lifeFor infants and young children with heart rhythm abnormalitiesinterventional treatment can be especially difficultas the size of their vasculature and or congenital anomalies typically preclude a transvenous approach for implanting a cardiac device such as a pacemaker or defibrillatorAs a resultinfants must undergo a sternotomy or thoracotomy to access the epicardial surface of the heartWe have developed a novel minimally invasive pericardial access tool to deliver pacing and defibrillation leads to the epicardial surface of the heart under direct visualization from an endoscopeUtilizing this toolwe hypothesize that we can safely and effectively deliver pacing and defibrillation therapy through a single small portBy using a percutaneous approachthis should reduce pain and risk of infectiondecrease procedure timesand minimize operative complications from an open surgical approachIn additiondirect visualization of the procedure makes it safer than blind pericardial puncturesOur team has utilized an immature porcine model for the acute implantation of cardiac devicesWe also demonstrated that cardiac therapy delivered by percutaneous approach was as safe and effective as an open surgical techniqueThe specificnear term goal of this project is to assess long term safety and efficacy of the implantation tool and techniques through the followingspecific aimsAimImprove the design and develop the process to manufacture the pericardial access tool for preclinical bench testingSuccess is defined as producing a minimum ofunits that pass preclinical bench testingsterilizationand post production quality controlsAimAssess the safety of the pericardial access tool in an acuteAimcomparison study to thoracic trocarsand the efficacyAimof accessing the pericardial space in a pericardial adhesion modelSuccess is defined as demonstrating safety of the procedure in acute infant pigletswith functional pacemakersdefibrillatorsmonths after implant in the efficacy studyThis research could have a transformative impact in changing current clinical practice by converting an open surgical approach to a minimally invasive percutaneous procedureWhile the study design focuses on the unique needs of infants and children with congenital heart diseaseextrapolation of these findings may benefit thousands of adult patients who have indications for cardiac resynchronization therapy but do not achieve successful implantation due to lack of transvenous access or adequate coronary sinus venous tributaries to pace key locations in the left ventriclewhich could be resolved with our proposed tools and techniques Project NarrativeWe are proposing novel tools and techniques to place pacemakers and cardiac defibrillators in infants and children with congenital heart diseasewho cannot receive devices via transvenous routeThis system allows for minimally invasive port access with direct visualization of the heart for safer implantation and avoiding the need for open chest surgeryWe hope this provides an important solution for this unique group of pediatric patients who are currently precluded from receiving standard pacemaker and defibrillator therapies