Given the close proximity of the esophagus to the posterior wall of the left atrium of the heart, thermal energy may enter into the esophagus during ablation, causing an atrio-esophageal (AE) fistula, which is an abnormal connection between the esophagus and atrium. It is among the most serious and life-threatening complications from ablation. This device works by using suction to pull the esophagus away using negative pressure during ablation procedures.
"While esophageal injury is uncommon during ablation, perforation of the esophagus can lead to sepsis, which is often fatal," Dr. Natale said. "This new device may allow us to better protect the esophagus during ablation, further reducing the risk of complication to ensure best possible outcomes for our patients."
TCAI physicians tested the esophageal protection device on approximately 10 patients in Europe, with plans to make it available to TCAI patients upon FDA approval. This technology could be available in the United States in two to three years.
Elizabeth Christian Public Relations