S4 Medical’s Esolution Esophageal Deviation Device Approved for Use in AFib Ablation Procedures

September 11, 2023—S4 Medical Corporation announced that it has received FDA de novo approval for the company’s Esolution esophageal deviation device. The device is designed to mitigate the risk of thermal injury to the esophagus during atrial fibrillation (AFib) ablation procedures. The most serious thermal injury complication, atrioesophageal fistula, is associated with high mortality, noted the company,

According to S4 Medical, the FDA approval was based on data from the EASY AF—Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation—randomized, prospective, multicenter, multinational, and double-blinded investigational device exemption study.

The EASY AF study, which enrolled 120 patients at 12 centers, demonstrated an 84% reduction in esophageal injury. The study also showed an 18% reduction in radiofrequency time and no device-related complications. The study was stopped early by recommendation of the Data Safety and Monitoring Board because of confirmation that the Esolution device demonstrated significant reduction of esophageal injury, advised the company.

Jose Osorio, MD, serves as Principal Investigator of the EASY AF study. Dr. Osorio is Director of Cardiac Electrophysiology at HCA Florida Miami in Miami, Florida, and Founder of Heart Rhythm and Clinical Research Solutions.

“I have seen a lot of innovation in electrophysiology and S4 delivered on something that solves a real problem, fits into the workflow, and works within the economics of AFib ablation,” commented Dr. Osorio in the company’s press release. “I was pleased to be a part of this study and look forward to using the Esolution device.”

EASY AF study investigators Rohit Mehta, MD, and Amin Al-Ahmad, MD, also commented on the device in the press release. Dr. Mehta is from Atrium Health Sanger Heart & Vascular Institute in Charlotte, North Carolina. Dr. Al-Ahmad is with Texas Cardiac Arrhythmia in Austin, Texas.

“Our experience with the device during the clinical trial was very positive and the trial results reinforce the safety and likely downstream efficacy we will see with use,” stated Dr. Mehta. “I am pleased there will soon be a commercially available device to help reduce esophageal complications.”

Dr. Al-Ahmad added, “The study showed very compelling data in reducing thermal injury. We also believe that there could be an increase in success rates because of the ability to perform more complete ablations without worry of esophageal complications.”

Finally, Emile Daoud, MD, who is S4 Medical’s Chief Medical Officer and Cofounder, as well as Section Chief of Electrophysiology at The Ohio State University Wexner Medical Center in Columbus, Ohio, stated, “No multicenter study has even been conducted in the United States specifically looking at endoscopic findings between control and treatment groups in atrial fibrillation. The data speaks for itself, and we look forward to using the Esolution in every AFib ablation procedure.”