Torax Medical Inc., a medical device company focused on the minimally invasive treatment of gastroesophageal reflux disease (GERD) has commenced a pivotal clinical trial of its LINX Reflux Management System.
The trial, which is being conducted at 15 leading academic and private medical centers in the U.S. and Europe, will evaluate the safety and effectiveness of the LINX System in patients suffering from GERD despite medical therapy.
GERD is caused by a defective lower esophageal sphincter, a ring-like muscular valve that surrounds the esophagus. When defective, it allows abnormal reflux of stomach acids and bile into the esophagus. Approximately 19 million adults in the U.S. suffer on a daily basis from the symptoms of GERD. Medical therapy, such as the daily use of proton pump inhibitors (PPIs), may improve heartburn symptoms but it does not address the mechanically defective sphincter, allowing gastric reflux to continue. Chronic gastric reflux may lead to numerous complications including ulcerations and esophageal cancer. The incidence of esophageal cancer is rising at a faster rate than any other cancer in the U.S.
Robert Ganz, M.D. of Minnesota Gastroenterology and a Principal Investigator in the trial shared these comments, "Many people who suffer from GERD do not get complete relief of symptoms with drug therapy. The LINX System is intriguing because it may provide both symptom relief and correction of the physiologic defect."
The LINX Reflux Management System is intended to restore the normal barrier function in the esophagus for patients who suffer from GERD and is designed to be an outpatient, minimally invasive procedure. The device is implanted laparoscopically, with the patient likely to resume normal activities and diet at discharge. In addition to its therapeutic benefits, Torax Medical anticipates that the LINX System will have the potential to eliminate the burdens associated with lifelong drug therapy and the typical complications associated with conventional surgical repair.
Todd Berg, President and CEO of Torax Medical, considers the LINX System a promising advancement for the treatment of GERD, "We believe the simplest approach to treating GERD is to augment the body's existing sphincter so that it can function normally. Excellent clinical results were achieved in feasibility trials with the LINX System and we expect these positive clinical outcomes to continue in this Pivotal Trial".