The device was approved to treat GERD (also known as acid reflux disease) on March 22 by the U.S., Food and Drug Administration (FDA). The Mayo Clinic in Florida will be one of the first health care institutions in the nation to offer the device.
C. Daniel Smith, M.D., chair of the Surgery Department at Mayo Clinic in Florida, an expert on the treatment of GERD who is experienced in using the device, reveals that the clinic expects to offer the device immediately.
The clinic was 1 of only 14 centers nationwide to take part in a clinical human trial that resulted in device's approval.
Dr. Smith explained:
"Mayo has been a leader in the treatment of esophageal diseases, especially GERD, and we are pleased to be offering this new treatment to our patients immediately."
GERD is a condition in which a ring of muscle (lower esophageal sphincter) between the lower esophagus and the top of the stomach doesn't close properly and as a result, causes the stomach contents (food or liquid) to flow back up into the esophagus.
Although medications to prevent GERD by neutralizing the acid in the stomach are available, if they fail to work, an operation to correct the mechanical defect is considered. According to Dr. Smith, around 1.5 - 2 million of those patients could benefit from significantly less complex treatment than current surgical options.
Dr. Smith, said:
"The new system will offer a long-needed treatment option for a large group of underserved patients."
Although results from the trial that resulted in the approval of the device have not been published, Dr. Smith explains that "the data presented to the FDA revealed striking results when compared to other GERD treatments that have been investigated over the past 20 years. The system offers effective control of GERD with limited side effects and thus far an excellent safety record."
The device, which serves as a mechanical augmentation of the lower esophageal sphincter, is a ring of tiny magnetic titanium beads wrapped around the junction between the stomach and esophagus.
Although the magnetic attraction between the beads is powerful enough to prevent acid reflux, the attraction is weak enough to allow food to enter into the stomach. Dr. Smith notes that the device can be implanted using minimally invasive surgery methods.
Over the past several decades, Dr. Smith has been involved with several new treatments and performs approximately 200 GERD-related surgeries per year.
Dr. Smith said:
"I expect this device to be a game changer for the treatment of GERD in select patients who have failed management with drugs."
Ken DeVault, M.D., chair of the Department of Internal Medicine at Mayo Clinic in Florida, who took part in these studies, said:
"I have many patients who are searching for something more than medication for their reflux, but have been hesitant to undergo traditional reflux surgery. I think this procedure may well be a very attractive option for that group."
In order to develop the LINX Reflux Management System, Mayo Clinic physicians and scientists worked together with Torax Medical. Mayo Clinic licensed related technology to the company in exchange for equity. Drs. DeVault and Smith are paid consultants to Torax Medical.
Written By Grace Rattue