Are you one of the 40% of people on PPIs dissatisfied with their current treatment? Do you continue to have symptoms while you are taking medications? If so, you might be interested in learning about the latest study on the LINX Reflux Management System. The study, published in the New England Journal of Medicine (February 21, 3013 issue), shows promising results for this device, designed to augment the valve between the stomach and esophagus.
About the LINX Reflux Management System
Why it was developed
Multiple studies have shown that about 60% of people with GERD are generally satisfied with their therapy, which usually includes PPIs. The other 40%, however, have persistent symptoms. Traditional antireflux surgery, laparoscopic Nissen fundoplication, is utilized by only 1%. LINX was developed by Torax Medical, Inc. to fill the needs of the 40% who continue to suffer.
How it works
The LINX Reflux Management System involves the placement of a ring, or “bracelet” of magnetic beads around the lower esophageal sphincter (LES), the valve that connects the esophagus and stomach. Reflux occurs when the LES is damaged and fails to function properly. The LINX system augments the function of the damaged valve. The bracelet “opens” (by separation of the magnetic beads) as food passes from the esophagus into the stomach. The ring of beads then closes after the food passes, augmenting the damaged LES and preventing reflux.
How the device is placed
The device is placed during a minimally invasive surgical procedure that takes typically 30-45 minutes. Since the treatment is new, patients typically stay in the hospital overnight, although the procedure is designed to be an outpatient procedure eventually. Immediately upon discharge patients resume full activity and a regular diet.
FDA approval of LINX
Initial studies of the device indicated that it was safe and effective, resulting in approval by the FDA in the spring of 2012.
What the latest study found
This latest study published in the New England Journal of Medicine reports on three-year data of a five-year study, which looked at 100 patients with GERD before and after treatment to determine the effect of the LINX implant. Torax Medical, Inc. sponsored the study.
Measure of Success
Three measures were used to evaluate success:
- Level acid exposure in the esophagus,
- Patient reports of reflux symptoms, and
- Level of PPI usage.
Overall, exposure to esophageal acid decreased, reflux symptoms improved, and the use of PPIs decreased. In fact, after 3 years, 64% of patients had acid reflux cut by at least half, 75% exhibited a significant improvement in quality of life, and 87% had been able to stop taking PPIs. Additionally, after three years, 94% of the patients were generally satisfied with their reflux condition compared to just 13% prior to the implant.
Most common side effects
The most common side effect was difficulty swallowing (dysphagia). More than half of patients had difficulty swallowing immediately after the implant, although that number dropped in the second (11%) and third (4%) years. Six patients had the device removed.
At the time of this study publication, almost 500 LINX devices have been placed worldwide with similar results.
Are you a candidate for LINX?
The LINX device is intended for patients who are dissatisfied with their treatment with PPIs and are looking for an alternative; however, not everyone is a candidate for the procedure. The device is not intended for those with a large hiatal hernia or whose LES function is completely degraded. The LINX system is currently only available at select centers around the United States with that number to increase substantially over the next several years.
Want to learn more about antireflux surgery? Our overview explains the procedures most commonly done today or check out Dr. Dengler’s posts on when to consider surgery and what to look for in a doctor.
(1) N ENGL J MED 368;8 FEBRUARY 21, 1013
Reviewed by: Dr. Dengler, RefluxMD Medical Director