# Improved Esophageal Safety in Atrial Fibrillation Elimination

> **NIH NIH R44** · BIOTEX, INC. · 2020 · $615,943

## Abstract

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.

## Key facts

- **NIH application ID:** 9928496
- **Project number:** 5R44HL144369-03
- **Recipient organization:** BIOTEX, INC.
- **Principal Investigator:** Ashok Gowda
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $615,943
- **Award type:** 5
- **Project period:** 2018-08-21 → 2022-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9928496

## Citation

> US National Institutes of Health, RePORTER application 9928496, Improved Esophageal Safety in Atrial Fibrillation Elimination (5R44HL144369-03). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9928496. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*