Safety of a Novel Upper Esophageal Sphincter Balloon Dilator.

Objective: The shape of esophageal dilators has not changed in over 350 years. Clinical and animal research suggests that the upper esophageal sphincter (UES) is not round but approximates a kidney shape and that cylindrical dilators may be suboptimal. The Infinity UES Dilation System has been developed specifically for the anatomic configuration of the UES. This study evaluates the safety of the UES-specific Infinity Dilation System.

Methods: All patients undergoing dilation of the UES between January 1, 2022 and September 1, 2023 were included. Demographics, procedure indication, dilator type, minor adverse events, and major complications were abstracted. Minor adverse events, complications, and maximum dilation dimension (mm) were compared between groups.

Results: A total of 477 patients were included. Eight hundred and seventy-three total UES dilations were performed. The primary indications for UES dilation were cricopharyngeus muscle dysfunction (43%) and stenosis from radiation toxicity (40%). Twenty-three percent (202/873) of dilations were performed with an Infinity balloon, 31% (270/873) were performed using two conventional balloons placed side by side, and 46% (401/873) were performed with one singleton conventional balloon. The average maximum dilation dimension was 33 (±4.7) mm for Infinity balloons, 32 (±3.8) mm for two side-by-side balloons, and 18 (±3.4) mm for singleton balloons. There were three major complications with conventional balloons and none with Infinity balloons. There were no significant differences in minor adverse events between groups.

Conclusions: A UES-specific esophageal dilator provides a greater maximum dilation dimension and appears to be at least as safe as dilation with a single cylindrical balloon designed to dilate the esophagus.

Level Of Evidence: 3 Laryngoscope, 135:66-72, 2025.