CELL PRESERVATION SERVICES INC — Department of Health and Human Services SBIR Phase I: R

Description

The need for the development of new strategies for treatment of cardiac arrhythmiasincluding ventricular arrhythmiashas experienced a palpable increase in the last few yearsVentricular ArrhythmiaVAor ventricular tachycardiaVTis a severe abnormal heart rhythm which can cause death if not treated immediatelyVentricular FibrillationVFis the most serious form of VAVF is most commonly caused by VT and is responsible forof sudden cardiac deathsSCDWhile several treatment options are currently in use under investigationmany if not all remain suboptimalThis is critical as it is estimated that SCD is responsible fordeaths in the US annuallyWhile various treatment options currently exista number of issues have been reported including the high cost of treatmentpatient discomfortorgan toxicity and incomplete treatment among othersAs such there is an ever growing urgency and compelling need for the development of new strategies and devices to treat VTThe intent of this project is to develop and characterize a new endovascular based endocardial cryoablation treatment strategy and catheter systemICEolatefor the treatment of VTThis technology will enable the focalspotas well as linear ablation lesions and have the capability of conducting electrical activity mappingincluding cryomappingof cardiac tissue prior to and following ablationAdditionallythe technology will be used in conjunction with transesophageal echocardiogram imaging which will enable direct visualization of lesion formationThe prototype unit and preliminary data collected to date strongly support the potential of this approachThe major goals of this Phaseproposal are todevelop the ICEolate cathetertest this new treatment protocol in an ex vivo tissue modelandconduct a pilot in vivo study to validate developmentThe successful completion of this project will lead to a new minimally invasive endovascular based approach for the management of VT and other cardiac arrhythmiasFurtherthis project will provide data in support of establishing dose parameters necessary for optimal clinical application for the treatment of cardiac arrhythmiasOnce completedthis project will provide for an effectiveminimally invasive treatment option for individuals suffering from VTcontributing to efforts for improving patient survival and quality of life This application proposes to develop a novel cryoablation strategy for the treatment of ventricular tachycardia and other cardiac arrhythmias