Thermedical Inc. — Department of Health and Human Services SBIR Phase II: NHLBI

Description

Ischemic ventricular tachycardiaVTcauses more than half of thesudden cardiac deathsSCDthat occur annually in the United StatesImplantable cardioverter defibrillatorsICDsare the standard of carebut they are expensivethe total cost of an ICD implant exceeds $and not curativePatients who receive ICDs are subject to periodic shocks to halt episodes of VTand those shocks can be traumaticRF ablation represents a potential method for curing VTand at a much lower cost than ICDsbut while RF ablation has been successful at treating atrial arrhythmiasit has not so far been as effective at treating VTAn ablation tool capable of treating VT has the potential to eliminate the need for ICD implantsgreatly reducing the cost to the health care system of treating VT while also improving the lives of patients affected by VTWe have developed an ablation system and catheter for the treatment of VTOur technology delivers heated saline along with RF energyand is unique in its ability to treat the large volumes of cardiac tissue necessary to eliminate arrhythmogenic tissue located deep in the ventricular wallOur technology is capable of treating much larger volumes of tissue than conventional RF because saline carries the heat generated by RF into tissue by convectionWe have demonstrated that our ablation system can cure VT in an infarcted animal modelOur primary aim is to carry out apatient clinical trial to establish the safety of our technology and to begin to demonstrate the efficacy of the Thermedical system for treatment of VTBefore beginning the human clinical trialwe will complete verification and validation activities to ensure the electrical safety of the system and the biocompatibility of the catheter materialsand to validate the catheter packaging and sterilizationAdditionallyprior to the human trial we will carry out a final safety study oninfarcted caninesWe will conduct thepatient study at the Mayo ClinicPatients will be eligible for the study if they have recurrentsymptomatic VTif they have failed prior cardiac catheter VT ablationif the etiology of the arrhythmia is related to ischemic structural heart diseaseand if a target arrhythmia has been treated by an implanted ICDThe primary safety endpoints of this study will be the absence of Major Adverse Cardiac EventsMACEprior to hospital discharge in more thanof the patientsand the absence of serious adverse events that are potentially device related withindays for more thanof the patientsThe primary efficacy endpoints of the study will be non inducibility of the clinical VT and treatment of clinically relevant scar