Mayo Clinic’s Magnetic Device for GERD Treatment Approved by FDA

July 05, 2012 -- A new device offers relief to GERD sufferers who have difficulty in following conventional medical therapy or who want to avoid a lifetime of dependence on medication. The device can be implanted using much less complex, minimally invasive surgical procedures, and has limited side effects and an excellent safety record.

GERD is a condition in which food or liquid in the stomach flows back into the esophagus as a result of a weakness in the lower esophageal sphincter (LES) which prevents it from closing properly, leading to acid reflux and heartburn. The newly approved LINX Reflux Management System is designed to encircle the LES and provide additional strength to close the weakened valve. The device is made up of a band of titanium beads, each with a magnetic core. When food is swallowed, the pressure of the swallowing force is sufficient to overcome the magnetic attraction between the beads, so the device expands, allowing food to pass through. Once the food passes though, however, the device returns to its resting state, preventing acid from leaking back through the LES.

C. Daniel Smith, M.D., chair of the Surgery Department at Mayo Clinic in Florida, and an internationally recognized expert on the treatment of GERD, says ”I expect this device to be a game changer for the treatment of GERD in select patients who have failed management with drugs,”

Although there is a possibility of adverse effects such as difficulty swallowing, pain when swallowing food, chest pain, vomiting, and nausea, results from feasibility and pivotal trials carried out in a 5-year follow-up plan by the company that developed the device indicate that the benefits obtained with the LINX Reflux Management System outweigh its risks. In considering this procedure, however, it is important to note that patients in whom the LINX device has been implanted will no longer be able to undergo Magnetic Resonance Imaging (MRI) procedures, since the magnetic beads will interfere with the machine and can cause injury to the patient and damage to the device.

Mayo Clinic in Florida expects to offer this new treatment immediately, and will be one of the first health care institutions in the United States to do so.

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