Improved Esophageal Safety in Atrial Fibrillation Elimination

Project Summary The overall goal of this SBIR proposal is to develop a novel device to allow easier atrial fibrillationAFablation procedures by mitigating risks for esophageal injuryAtrial fibrillation is the most common chronic disease of heart rhythmand can be treated with application of radiofrequency energy or cryo to ablate susceptible portions of the endocardial surface of the pulmonary veins through the left atriumComplications of this procedure include injury to the esophaguswhich lies immediately posterior to the thin walled left atriumInjury can range from asymptomatic ulcerations in the esophageal lumento rarebut catastrophic atrioesophageal fistulaAEFwith subsequent stroke and deathCurrentlymethods to avoid these complications include avoiding ablation withincm of the esophagusand esophageal temperature monitoringHowevermost patientsanatomy precludes avoiding ablation within one centimeter of the esophagusTemperature monitoring and avoiding exceeding a certain temperature threshold can prolong the procedure and decreases procedural success ratesIn fact a significant high rate of procedures must be aborted because the position of the esophagus relative to the ablation site creates unacceptably high risk for injuryIn our physician collaborator s practice inofof pulmonary vein isolation procedures had incomplete isolation of at least one vein due to proximity of the esophagusIt s clear that current techniques to protect the esophagus during ablation procedures are rudimentaryand no purpose built device has received FDA approval for this indicationBioTex has licensed from the Texas Heart Institute and Baylor College of Medicine to create the first ever device designed for controlled deformation of the esophagus away from the left atrium and pulmonary veins as well as enhanced temperature monitoring to improve the safety and efficacy of atrial fibrillation ablation proceduresThe objective of this Fast Track proposal is to build fully functional prototypesconduct benchtop testingperform pilot animal studies demonstrating reduction of the rate of esophageal injury during radiofrequency ablationcomplete a final design of the devicecomplete all required validationsand obtain regulatory marketing clearancesWe anticipate this novel approach will be an easy replacement for existing esophageal temperature monitoring methodsand have a significant impact on patient safety and allow significant improvements in procedure efficiency and health care cost savings Project Narrative This proposal aims to develop a fully functional esophageal protection device to temporarily deform the shape of the esophagus and monitor luminal temperature during atrial fibrillation ablation proceduresThis project proposes to bring together expertise in medical device development with clinical collaborators to develop a novel device for protecting the esophagus during atrial fibrillation ablation procedures and solve an important problem for all cardiologist performing such proceduresThe developed technology is expected to have a significant impact on patient safetyprocedure timeand likely resulting efficacy by allowing more effective ablation of areas that might otherwise be too close to the esophagus to treat adequately