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.