There’s good news for millions of heartburn sufferers: a new treatment may be on its way. Medtronic, a leading medical technology company, has announced the start of a clinical trial that could lead to U.S. Food and Drug Administration approval of its Gatekeeper Reflux Repair System. The system was already approved in Europe last spring. Gatekeeper attacks acid reflux right where it starts: in the lower esophageal sphincter, or LES. The LES, located at the junction between the esophagus and stomach, is supposed to let food into the stomach without letting it come back up. When age or other factors weaken the LES, heartburn can develop.
The Gatekeeper is a prosthesis made of a material similar to that used in contact lenses. The physician uses an endoscope to place the prosthesis into the esophageal wall. It is dry when inserted, but expands when it contacts moisture. This expansion creates a barrier that helps keep food in the stomach.
The Gatekeeper system is less invasive than traditional surgical procedures used to treat gastroesophageal reflux disease (GERD), said Dr. Bergein Overholt of Gastrointestinal Associates in Knoxville, Tenn., who performed the first U.S. clinical implant of the Gatekeeper system on a 28-year old male patient without complication.
"Gatekeeper Therapy may have the potential for reducing patients’ dependence on medications and improving their GERD symptoms," he added.
Dr. Paul Fockens, director of endoscopy at the University of Amsterdam Academic Medical Center, agreed. "Actually repairing the LES with the Gatekeeper System is an exciting possible alternative to expensive drug therapy and complicated, invasive LES fundoplication surgery," he said. "Not only does the procedure hold the possibility of replacing traditional therapies in some cases, we may also be able to realize significant cost savings for long-term GERD therapy."
Medtronic’s Bravo pH Monitoring System will be used to measure acid levels during the clinical trial. The Bravo system is a catheter-free technique that works while patients engage in normal daily activities. A capsule is placed in the esophageal wall after endoscopy, and it transmits data to a receiver worn by the patient.
For more information about Gatekeeper therapy, call 1-800-664-5111.
