Mayo Clinic in Jacksonville, Fla., is among 15 centers worldwide studying the safety and effectiveness of an innovative, surgically implanted, investigation device for treating gastro-esophageal reflux disease (GERD).
GERD is a progressive disease resulting from a weak or defective lower esophageal sphincter. The defective sphincter, normally closed unless food or liquid passes to the stomach, allows stomach contents to reflux into the esophagus, causing heartburn and damaging the esophagus. About 20 million Americans suffer daily from GERD, often resulting in life-long medical therapy.
"Medical therapy is effective in controlling and suppressing acid production in the stomach but does not address the source of the reflux, which is a malfunctioning esophageal sphincter," said C. Daniel Smith, M.D., a Mayo Clinic surgeon investigating the new treatment. "This new device is designed to restore the function of the esophageal sphincter and prevent reflux."
If the device proves effective, Dr. Smith says, "It could make a significant difference in the treatment options we can offer patients."
The device is a ring of magnetic beads that is placed laparoscopically using small incisions in a procedure that takes less than an hour. The magnetic ring helps to keep the sphincter closed, but the magnets release and allow the valve to open under the pressure of food or drink in the esophagus. The system was evaluated in a feasibility study, which validated its ability to significantly reduce the incidence of reflux, restoring acid exposure to normal levels for most of patients in the study. The current clinical study will evaluate the safety and effectiveness of the system.
Reference: For more information about the clinical trial, contact study coordinator Barbara Berg @ 904-953-2854.
This study is funded by the manufacturer, Torax Medical Inc. Dr. Smith has no financial interest in the technology or company related to this research.