News Archive

MUSC Hopes to Launch Clinical Research Study for GERD Patients That Don't Respond to Drugs

January 19, 2012 – It is generally accepted that approximately 40% of the U.S. population has symptoms of gastroesophageal reflux disease (GERD). In addition, for about 40% of those patients, their symptoms fail to respond to the major therapy of this condition, proton pump inhibitors (PPIs). In this situation, a surgical procedure known as a laparoscopic fundoplication is often considered the next option. There has been considerable interest for years in the development of a less invasive surgical approach to this condition.

The LINX System is designed to help
the lower esophageal sphincter (LES)
resist opening to gastric pressures.

On January 11, representatives of Torax Medical Inc. successfully presented data to a public hearing of the U.S. Food & Drug Administration (FDA) regarding implantation of a LINX device, a series of titanium magnets around the junction of the esophagus and stomach via a limited surgical (laparoscopic) approach. (Read Torax press release.) Because of the minimal surgery and the absence of adverse effects combined with excellent clinical responses at two years in the early studies, an FDA advisory board consisting of gastroenterologists, surgeons and others voted unanimously (9-0) as a recommendation for commercial use of this novel new GERD therapy.

FDA Panel Backs New Device for Chronic Heartburn (MedicineNet.com)

This decision was particularly encouraging to the GI team at MUSC since Dr. David Adams (Head, General and Gastrointestinal Surgery and Co-Director, Digestive Disease Service Line) and I are hoping to begin a study with this approach at MUSC in patients with poor response to PPI therapy.