C. Daniel Smith, M.D. , chair of the Department of Surgery at Mayo Clinic in Florida, discusses minimally invasive surgical options for patients with gastroesophageal reflux disease (GERD). A novel device, a ring of tiny magnetic titanium beads that acts to keep stomach acid from leaking into the esophagus, is now offered at Mayo Clinic in Florida. Read more about the LINX Reflux Management System in the April 11, 2012, edition of MedCity News.
Mayo Clinic in Florida is one of the first health care institutions in the U.S. to offer a newly approved device to treat GERD. Mayo Clinic in Florida helped test the device in patients. The U.S. Food and Drug Administration (FDA) approved the device and treatment procedure on March 22, 2012, for patients with GERD who continue to have chronic reflux symptoms despite taking medication. Mayo Clinic in Florida was one of 14 centers nationally that participated in a clinical trial that led to the FDA’s approval of the device.
In patients with gastroesophageal reflux disease, liquid or food in the stomach flow back up into the esophagus due to the inability of a ring of muscle between the lower esophagus and the top of the stomach to close properly. If drugs aimed at neutralizing the acid in the stomach fails to prevent GERD, an operation designed to correct the mechanical defect is considered. Nearly 2 million patients of those patients could benefit from this treatment, which is much less complex than current surgical options, says Dr. Smith.
The results of the clinical study that led to approval of the device have not yet been published. “The data presented to the FDA, however, revealed striking results when compared to other GERD treatments that have been investigated over the past 20 years,” says Dr. Smith. “The system offers effective control of GERD with limited side effects and thus far an excellent safety record.”
The implanted device is a ring of tiny magnetic titanium beads that is wrapped around the junction between the stomach and esophagus, serving as a mechanical augmentation of the lower esophageal sphincter (the ring of muscle). The magnetic attraction between the beads is strong enough to keep the sphincter closed to refluxing acid, but weak enough so that food can pass through it into the stomach. The device can be implanted using minimally invasive surgery methods.
“I expect this device to be a game changer for the treatment of GERD in select patients who have failed management with drugs,” says Dr. Smith.
Kenneth R. DeVault, M.D. , chair of the Department of Internal Medicine at Mayo Clinic in Florida, also participated in the studies. “I have many patients who are searching for something more than medication for their reflux, but have been hesitant to undergo a traditional reflux surgery,” he says. “I think this procedure may well be a very attractive option for that group.”
Drs. Smith and DeVault were consultants to the company that developed the device and participated in the research study. Mayo Clinic licensed related technology to the company in exchange for equity.
For more information
View the Torax Medical, Inc. presentation at the January 2012 Gastroenterology and Urology Medical Devices Panel Meeting and read the FDA Executive Summary Memorandum.
Clinical trials at Mayo Clinic
Gastroesophageal reflux disease (GERD)