CLEVELAND, September 12, 2022 (Newswire.com) - S4 Medical Corp, an Ohio-based company with technology originating from The Ohio State University, announced that it is stopping the Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation (EASY AF) Study due to successful achievement of the primary endpoint. After review of the data, the Data Safety and Monitoring Board advised to stop the study, as the study data demonstrates a statistically significant reduction in thermal injury to the esophagus during atrial fibrillation catheter ablation procedures.
The EASY AF Study was conducted under an investigational device exemption (IDE) approved by the U.S. Food and Drug Administration (FDA) as a prospective, multicenter, randomized controlled, double-blinded clinical study to assess a reduction of esophageal lesions attributable to radiofrequency (RF) ablation with use of Esolution (esophageal retractor) in comparison to conventional therapy (no use of an esophageal retractor). The study treated 120 patients at 11 study centers in the USA and one in Argentina.
The study was kicked off in September 2021 during the global COVID-19 pandemic. Despite this challenging environment, the company pulled off the study and met its primary endpoint. "We are thrilled with the positive results of the EASY AF Study," says National P.I. Raul Wiess, MD of The Ohio State University. "The data speaks for itself and is a testament to a well-designed device, well-designed protocol, and excellent execution of a complex study."
"A heartfelt thank you to the patients, study physicians, and research coordinators for their efforts, and we very much look forward to being able to present and publish the complete study details in the near future," says Emile Daoud, MD, Chief Medical Officer and cofounder of S4 Medical. "Based on the results of the study, we feel even more strongly there is evidence that the Esolution device may provide an important option to reduce a serious complication of catheter ablation," says Daoud.
"Completion of the IDE study and meeting our primary endpoint was a massive milestone for S4," says William Fuller, CEO and co-founder of S4 Medical. "We are another step closer to a breakthrough in esophageal management during AF ablation procedures," says Fuller. The company, formed in late 2017, will now move towards submitting this data to the FDA in its application for premarket approval for the Esolution device.
Jose Osorio, MD, Director of Cardiac Electrophysiology at Grandview Medical Center and founder of Heart Rhythm and Clinical Research Solutions, was a significant enroller in the EASY AF Study. "I was impressed with the device, the study, the way it integrated into my workflow, and I believe S4 is addressing an important medical need," says Osorio.
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, yet comprehensive solution intended at reducing complications to the esophagus during catheter ablation treatment for atrial fibrillation. S4's team is motivated by providing advanced solutions that improve healthcare. The Esolution device is an investigational device and has not been approved by the FDA for commercial use.
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Source: S4 Medical Corp