FDA greenlights esophagus-moving device to protect the organ during afib ablation procedures

The FDA has granted a de novo clearance to a small, vacuum-powered catheter designed to take hold of a patient’s esophagus and gently move it out of the way during cardiac ablation procedures aimed at treating atrial fibrillation.

One of the most common irregular heart rhythms, affecting millions of people in the U.S., afib is frequently treated by delivering thermal ablation within the heart’s left atrium. However, that heat energy can travel outside of the beating cardiac muscle—and with the esophagus only separated from the outer wall of the atrium by a thin layer of fat, unintended damage to the organ can lead to long-term and potentially deadly complications.

S4 Medical’s solution is the Esolution, an esophagus-retracting catheter that is inserted into a patient’s mouth and down their throat. The device, developed first at The Ohio State University, uses suction at its tip to hold onto the organ from the inside, then curves to physically keep the esophagus away from the energy source.

The company’s previous studies using animals have shown that by moving it to the side by about 20 mm or more, temperature changes in the walls of the esophagus can be kept under 0.2 degrees Celsius during high-power ablation.

S4 Medical’s clinical study in humans was stopped early last year after the trial successfully met its primary goal ahead of schedule, by reducing the number of esophagus injuries compared to standard ablation procedures by 84%. 

The Centers for Disease Control and Prevention estimate that more than 12 million people in the U.S. will be diagnosed with afib in 2030—and developers of heart ablation procedures have been seeking ways to minimize potentially harmful side effects.

One of those methods includes developing pulsed field ablation—a next-generation technique being worked on at Boston Scientific, Medtronic and Johnson & Johnson’s Biosense Webster division—which uses tuned electric fields to target the heart’s contracting muscle cells, while avoiding damage to more-resistant nerve cells and nearby tissues such as the esophagus.