JACS reports study on LINX Reflux Management System for GERD treatment

An estimated 1 in 5 U.S. adults suffer from Gastroesophageal Reflux Disease (GERD), a chronic, often progressive disease that can cause debilitating symptoms and in certain cases lead to esophageal cancer. GERD is caused by a weak esophageal sphincter muscle that opens abnormally allowing harmful gastric fluids from the stomach to reflux into the esophagus. Acid reflux medications, such as Prevacid®, Nexium®, and Prilosec®, are designed to reduce the amount of acid in the stomach, but they do not prevent reflux from occurring. The Journal of the American College of Surgeons (JACS) reports on a study from a leading medical center that implanted the LINX® Reflux Management System, an FDA-approved medical device for the treatment of GERD. Based on the results of this study, this center has adopted LINX as the standard of care.

In the study, over a period of six years 100 consecutive patients suffering with GERD who had been on daily reflux medications for several years underwent laparoscopic surgery to have the LINX System implanted. The primary reasons cited for undergoing the procedure were the ineffectiveness of acid reflux medications, poor quality of life, and fear of cancer. At a median follow-up of 3 years post implant, 93% of patients reported significant improvement in their quality of life, and 85% reported complete cessation of their acid reflux medication. There were no intraoperative complications related to the LINX System. For more information, please visit http://www.journalacs.org/article/S1072-7515(13)00356-6/abstract.

These results were consistent with the results from a multicenter, prospective trial of the LINX System published this year in the New England Journal of Medicine, conducted as part of the FDA pre-market approval process.

The LINX System offers an alternative to the Nissen fundoplication, a surgical procedure in which part of the stomach is wrapped around the esophagus in order to reconstruct the sphincter. This procedure permanently alters the normal anatomy and, compared to implanting the LINX System, is more invasive. During a LINX procedure, a surgeon implants a small device comprised of magnetic beads around the weak sphincter, while leaving the stomach intact. The magnets support the weak sphincter to help prevent reflux. In the study, both the LINX System and the Nissen fundoplication were offered to each patient; all but one patient elected the LINX procedure. Post procedure and follow up, 91% of patients responded that they would undergo the LINX procedure again.

Philip O. Katz, M.D., Chairman of Gastroenterology at Albert Einstein Medical Center and past president of the American College of Gastroenterology, commented, "Currently we have limited options for treatment of patients who have incomplete symptom relief with acid suppression medications. The reflux inhibitor Baclofen is limited by side effects and is not FDA approved. Antireflux surgery has been underutilized due to concern for waning of initial success and potential side effects. Endoscopic options such as Endocinch, radio frequency application, and TIF have met with limited success in selected patients. As such, there is a real therapy gap between medical therapy and fundoplication. Magnetic sphincter augmentation offers an exciting and needed new surgical option for these patients."

Source:

Torax Medical, Inc.

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