S4 Medical announced today that its EASY AF FDA study data was published in JACC: Electrophysiology.
| CHAGRIN FALLS, Ohio , Feb. 1, 2024 /PRNewswire/ -- S4 Medical announced today that its EASY AF FDA study data was published in JACC: Electrophysiology. This prospective, randomized, multicenter, double-blinded study was completed at 12 centers and evaluated esophageal injury related to ablation energy for ablation of atrial fibrillation using the Esolution® esophageal deviation device. The Data Safety and Monitoring Board recommended stopping the study early due to an 85% reduction in esophageal injury with use of Esolution with no device-related adverse events. Based on this data, Esolution became the first device approved by the FDA to reduce the risk of ablation-related esophageal injury. The Esolution device is designed with a pliable outer sheath for safe esophageal intubation, and then vacuum suction holes that allow the device to apply a circumferential suction force that pulls in all the walls of the esophagus. Esolution uses its bilateral deflecting arm to deviate the segment of the esophagus to the right and left without device repositioning. “The Esolution device truly represents a breakthrough in adding safety to ablation of atrial fibrillation,” said Emile Daoud, M.D., S4 Medical Chief Medical Officer. “Our goal was to improve outcomes without any interruption in workflow and no added procedure time. To have achieved these goals will translate to enhanced patient care and procedural outcomes.” “With more than 300,000 atrial fibrillation ablation procedures in the U.S. alone and the risk of esophageal injury to so many patients, we are pleased to provide a simple solution that allows physicians to treat patients with significantly reduced risk,” said William Fuller, Cofounder and CEO of S4 Medical. “While others are attempting to manage thermal injury through temperature, esophageal cooling, and other methods, the Esolution is the only device that deviates the esophagus away from the treatment zone, protecting this anatomy so that the operator can focus on the ablation procedure.” About S4 Medical Corp S4 Medical Corp is a medical device company focused on innovative solutions for cardiac procedures. The company’s initial product is a simple solution intended to reduce complications to the esophagus during catheter ablation procedures for atrial fibrillation. S4’s team is motivated by making medical procedures safer and more effective. For more information please visit S4medical.com. Media Contact
SOURCE S4 Medical |
View original content:
