SBIR-STTR Award

The overall goal of this SBIR proposal is to develop a novel device to allow easier atrial fibrillation (AF) ablation procedures by mitigating risks for esophageal injury. Atrial fibrillation is the most common chronic disease of heart rhythm, and 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 atrium. Complications of this procedure include injury to the esophagus, which lies immediately posterior to the thin walled left atrium. Injury can range from asymptomatic ulcerations in the esophageal lumen, to rare, but catastrophic atrioesophageal fistula (AEF) with subsequent stroke and death. Currently, methods to avoid these complications include avoiding ablation within 1cm of the esophagus, and esophageal temperature monitoring. However, most patients’ anatomy precludes avoiding ablation within one centimeter of the esophagus. Temperature monitoring and avoiding exceeding a certain temperature threshold can prolong the procedure and decreases procedural success rates. In 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 injury. In our physician collaborator’s practice in 2016, 19% (41 of 218) of pulmonary vein isolation procedures had incomplete isolation of at least one vein due to proximity of the esophagus. It’s clear that current techniques to protect the esophagus during ablation procedures are rudimentary, and no purpose-built device has received FDA approval for this indication. BioTex 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 procedures. The objective of this Fast Track proposal is to build fully functional prototypes, conduct benchtop testing, perform pilot animal studies demonstrating reduction of the rate of esophageal injury during radiofrequency ablation, complete a final design of the device, complete all required validations, and obtain regulatory marketing clearances. We anticipate this novel approach will be an easy replacement for existing esophageal temperature monitoring methods, and have a significant impact on patient safety and allow significant improvements in procedure efficiency and health care cost savings.

Public Health Relevance Statement:
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 procedures. This 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 procedures. The developed technology is expected to have a significant impact on patient safety, procedure time, and likely resulting efficacy by allowing more effective ablation of areas that might otherwise be too close to the esophagus to treat adequately.

Project Terms:
Ablation; Anatomy; Animals; Area; Arrhythmia; Atrial Fibrillation; Burn injury; Cessation of life; Chronic Disease; Cicatrix; Clinical; college; commercialization; Communication; Complication; Cost Savings; Data; design; Detection; Device Designs; Device or Instrument Development; Devices; Distal; Ensure; Esophageal; Esophageal injury; Esophagus; esophagus ulcer; Family suidae; Feedback; Fistula; Fund Raising; Goals; Health Care Costs; Heart; Heart Atrium; heart rhythm; high risk; improved; In Situ; Individual; Injury; Institutes; Left; Left atrial structure; Life; Literature; Marketing; Measurement; Measures; Medical Device; Medicine; Methods; Modeling; Monitor; mortality; Movement; novel; novel strategies; patient safety; Patients; Performance; Pharmaceutical Preparations; Phase; Physicians; Positioning Attribute; Procedures; product development; prototype; Publishing; Pulmonary veins; Radiation exposure; radiofrequency; Radiofrequency Interstitial Ablation; Risk; Safety; seal; sensor; Shapes; Site; Small Business Innovation Research Grant; Stroke; success; Suction; Surface; Techniques; Technology; Temperature; Testing; Texas; Thinness; Time; Tissues; Ulcer; Validation; Veins; verification and validation

The overall goal of this SBIR proposal is to develop a novel device to allow easier atrial fibrillation (AF) ablation procedures by mitigating risks for esophageal injury. Atrial fibrillation is the most common chronic disease of heart rhythm, and 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 atrium. Complications of this procedure include injury to the esophagus, which lies immediately posterior to the thin walled left atrium. Injury can range from asymptomatic ulcerations in the esophageal lumen, to rare, but catastrophic atrioesophageal fistula (AEF) with subsequent stroke and death. Currently, methods to avoid these complications include avoiding ablation within 1cm of the esophagus, and esophageal temperature monitoring. However, most patients’ anatomy precludes avoiding ablation within one centimeter of the esophagus. Temperature monitoring and avoiding exceeding a certain temperature threshold can prolong the procedure and decreases procedural success rates. In 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 injury. In our physician collaborator’s practice in 2016, 19% (41 of 218) of pulmonary vein isolation procedures had incomplete isolation of at least one vein due to proximity of the esophagus. It’s clear that current techniques to protect the esophagus during ablation procedures are rudimentary, and no purpose-built device has received FDA approval for this indication. BioTex 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 procedures. The objective of this Fast Track proposal is to build fully functional prototypes, conduct benchtop testing, perform pilot animal studies demonstrating reduction of the rate of esophageal injury during radiofrequency ablation, complete a final design of the device, complete all required validations, and obtain regulatory marketing clearances. We anticipate this novel approach will be an easy replacement for existing esophageal temperature monitoring methods, and have a significant impact on patient safety and allow significant improvements in procedure efficiency and health care cost savings.

Public Health Relevance Statement:
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 procedures. This 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 procedures. The developed technology is expected to have a significant impact on patient safety, procedure time, and likely resulting efficacy by allowing more effective ablation of areas that might otherwise be too close to the esophagus to treat adequately.

NIH Spending Category:
Bioengineering; Cardiovascular; Heart Disease; Patient Safety

Project Terms:
Ablation; Anatomy; Animals; Area; Arrhythmia; Atrial Fibrillation; Burn injury; Cessation of life; Chronic Disease; Cicatrix; Clinical; college; commercialization; Communication; Complication; Cost Savings; Data; design; Detection; Device Designs; Device or Instrument Development; Devices; Ensure; Esophageal; Esophageal injury; Esophagus; esophagus ulcer; Family suidae; Feedback; Fistula; Fund Raising; Goals; Health Care Costs; Heart; Heart Atrium; heart rhythm; high risk; improved; In Situ; Individual; Injury; Institutes; Left; Left atrial structure; Life; Literature; Marketing; Measurement; Measures; Medical Device; Medicine; Methods; Modeling; Monitor; mortality; Movement; novel; novel strategies; patient safety; Patients; Performance; Pharmaceutical Preparations; Phase; Physicians; Positioning Attribute; Procedures; product development; prototype; Publishing; Pulmonary veins; Radiation exposure; radio frequency; Radiofrequency Interstitial Ablation; Risk; Safety; seal; Shapes; Site; Small Business Innovation Research Grant; Stroke; success; Surface; Techniques; Technology; Temperature; Testing; Texas; Thinness; Time; Tissues; Ulcer; Validation; Veins; verification and validation