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Home Industry News S4 Medical Gets FDA Authorisation for Esophageal Deviation Instrument

S4 Medical Gets FDA Authorisation for Esophageal Deviation Instrument

20th September 2023

S4 Medical Corporation is dedicated to enhancing safety in atrial ablation treatments and stated that the U.S. FDA had granted de novo certification for their esolution® esophageal deviation instrument.

The conclusive research revealed an 84% decrease in esophageal damage, an 18% decrease in radiofrequency duration, and no problems involving the device.

A recognized and significant consequence of atrial fibrillation (AF) ablation operations is thermal damage to the esophagus. The FDA has now authorized the esolution device as part of an initial strategy to reduce the chance of severe consequences, including chance of death.

CEO of the company, William Fuller, explained that although existing ablation methods are successful, esophageal damage is a possibility with each surgery. “This is an important day for patients with AF and their care providers. Protecting the esophagus is long overdue.”

“No multi-center study has even been conducted in the U.S. specifically looking at endoscopic findings between control and treatment groups in atrial fibrillation,” says co-founder and Chief Medical Officer Emile Daoud, MD, of The Ohio State University. “The data speaks for itself, and we look forward to using the esolution in every AF ablation procedure.”

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