New Treatment for Reflux Gains FDA Clearance

The FDA has cleared a new system for the treatment of gastroesophageal reflux disease (GERD). GERD is caused by a weakened lower esophageal sphincter between the esophagus and stomach that allows bile and acid from the stomach to reflux back up into the esophagus, causing heartburn and irritation of the esophagus.

The Stretta Procedure, developed by Curon Medical Inc., applies controlled radiofrequency energy through a flexible catheter to the lower esophageal sphincter (LES) muscle and gastric cardia to create thermal lesions. As the lesions heal, the barrier function of the LES is augmented, reducing the frequency of reflux events.

Clinical trials showed that Stretta reduced the exposure of the esophagus to acid in the majority of patients and significantly reduced heartburn and regurgitation. Of the patients studied, 70% were able to discontinue acid-suppressing medications and 87% discontinued proton pump inhibitor medications.

Curon Medical Inc. (Sunnyvale, CA) was formerly known as Conway Stuart Medical Inc.

Edited by Ursula Jones