S4 Medical Secures FDA Approval for esolution®, a Breakthrough Esophageal Protection Device in Atrial Fibrillation Ablation

S4 Medical is committed to improving the safety of atrial fibrillation ablation procedures. The recent FDA approval of its esolution® Esophageal Deviation Device was based on data from the EASY AF (Esophageal Deviation During Atrial Fibrillation Radiofrequency Ablation) study.The study enrolled 120 patients across 12 centers and showed an 84% reduction in esophageal injuries. The study also demonstrated an 18% decrease in radiofrequency time with no device-related complications.

Esophageal thermal injury is a known serious complication associated with atrial fibrillation (AF) ablation procedures. The most severe complication is esophageal fistula, which is caused by esophageal thermal injury and has a high mortality rate. The approval of the Esolution device represents the first FDA-approved treatment strategy to mitigate this risk.

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Catheter ablation is a surgical procedure used to treat patients with refractory paroxysmal and persistent atrial fibrillation. Ablation modifies electrical pathways in the heart tissue by locally targeting cells that support problematic current pathways. In examples of ablation used to treat atrial fibrillation, a common strategy is to create lesions at specific target locations, such as the top of the left atrium, the mitral isthmus, or the posterior wall.

One of the highest risks during the ablation procedure is esophageal injury.The esophagus is often in close proximity or in contact with the left atrium. Damage to esophageal cells during ablation can lead to death. One factor contributing to damage and mortality is the sensitivity of esophageal tissue to radiofrequency energy and/or heat, both of which can directly harm esophageal tissue and/or the esophageal artery. Therefore, esophageal deflection is a critical step in this surgical procedure.

Last year, S4 Medical completed a multicenter, randomized, blinded, prospective IDE study, which was stopped early based on the recommendation of the Data Safety and Monitoring Board, as it was confirmed that the esolution device significantly reduced esophageal injury. Dr. Emile Daoud, co-founder and Chief Medical Officer of Ohio State University, stated that no multicenter studies have been conducted in the U.S., particularly comparing endoscopic findings between atrial fibrillation control and treatment groups. The data speaks for itself, and there is anticipation for using this solution in future AF ablation procedures.

Atrial fibrillation (AF) is an epidemic. Globally, approximately 33 million people have AF, with 1 million Americans diagnosed with the condition each year. As the global population ages, cases are expected to continue growing for decades.

Innovations in catheter ablation technology have made procedures safer and more effective, but the risk of esophageal injury still exists. The energy delivered during catheter ablation can pass through the heart wall and cause damage to the esophagus. Doctors have found that this occurs more frequently than previously thought.

According to reports, inUp to 47% of patients undergoing catheter ablation for atrial fibrillation may experience esophageal injuries related to the ablation energy, and a small proportion of these patients may develop life-threatening esophageal fistulas.To avoid esophageal injury, electrophysiologists often modify the delivery of ablation energy, but this may affect the outcome and efficiency of the procedure.

The esolution device of S4 Medical is a patented technology designed to safely deflect and protect the esophagus. Developed by a team of doctors including electrophysiologists, cardiac anesthesiologists, and gastroenterologists, esolution isThe only device with the potential to protect the esophagus during catheter ablation。

# About S4 Medical

S4 Medical Corp is a medical device company focused on innovative solutions for cardiac surgery, headquartered in Ohio, USA, and dedicated to improving the safety of atrial fibrillation ablation procedures. The company's initial product is a simple solution designed to reduce complications to the esophagus during atrial fibrillation catheter ablation. The goal of the S4 team is to make medical procedures safer and more effective.