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.
About GERD
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)
I have been taking Nexium for several years with no result. I would like information on the procedures and where is the Clinic located in Florida.
Thank you for contacting Mayo Clinic. The Mayo websites include a wealth of information about gastroesophageal reflux disease. Please visit http://www.mayoclinic.org/gerd/ and http://www.mayoclinic.com/health/gerd/DS00967. The appointment information for Mayo Clinic in Jacksonville, Florida, is available at http://www.mayoclinic.org/gerd/appointments.html#florida.
how much does this cost without any insurance?
Thank you for contacting Mayo Clinic. The recommended course of treatment depends on each patient’s specific medical situation and so the expense also varies. The cost of treatment can be estimated after a course of treatment is determined for your condition. For an appointment for evaluation of your health situation, please contact Appointments at http://www.mayoclinic.org/patientinfo/appointments.html.
I saw this new treatment and thought it was extremely interesting. However, I have also heard that acid reflux patients cannot undergo an MRI after having it. Isn’t that a significant issue?
Dr. Smith responds: Yes, it is true that patients who have had this device implanted should not undergo an MRI. For most patients a CT scan can achieve the same results as an MRI and patients with this device can undergo a CT, so this is not a strong reason to avoid this procedure and device. Also, there have been a few patients with this device who have accidentally undergone an MRI without any problems or complications. This has lead to some current research to see if an MRI is possible with this device. Again, at this time the FDA guidelines for this device would be to not have an MRI if you’ve had this device implanted.
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I’ve always been a strong advocator of surgery for people who suffer from severe acid reflux. I’ve never been to fond of PPIs or other otc drugs. I personally feel that if your reflux is so severe that it can’t be treated with simple lifestyle and diet changes, surgery would be the best alternative.
I am wondering if this device works for people who have a hiatel hernia? My prescription PPI’s help manage symptoms but I still have problems, especially at night. I know there is surgery to help hiatel hernias but apparently mine is not large enough to warrant the surgery even though I continue to have issues.
“This device can be used in patients with small hiatal hernias (3cm or smaller). It has not been tested in patients with a hiatal hernia larger than 3 cm and therefore the FDA has restricted its use in those patents,” Dr. Smith responds.
The Mayo Clinic websites include a wealth of information about gastroesophageal reflux disease. Please visit http://www.mayoclinic.org/gerd/ and http://www.mayoclinic.com/health/gerd/DS00967. Appointment information for Mayo Clinic is available at http://www.mayoclinic.org/patientinfo/appointments.html.
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