Wednesday, February 25, 2009

Magnetic Beads for Reflux?

Filed under: Surgery

Gastroesophageal reflux disease (GERD) is considered to be a structural disorder. Usually the problem lies in the lower esophageal sphincter, that in certain patients is a little too loose at times, sending acidic stomach contents back up into the esophagus. The disease can lead to painful erosive esophagitis, or even serious conditions such as esophageal cancer.

A new clinical trial for the LINX Reflux Management System, a product of Torax Medical, Inc. (Shoreview, MN), is being conducted at selected U.S. and European centers. The device, described as a "bracelet" around the Lower Esophageal Sphincter composed of a series of miniature magnetic beads, can be implanted laparoscopically.

One of the hospitals in the United States, the UC San Diego Medical Center, is now actively participating in this early trial, as its press release testifies:

During a 20-30 minute minimally invasive surgical procedure, the device, made up of a series of magnetic beads, is secured around the bottom of the esophagus. Once in place, the magnetic attraction between the beads supports the valve to protect the esophagus from reflux, while still allowing it to open during swallowing or to release gas. Made of permanent rare earth magnets encased in titanium, the band is sized to fit each patient.

"With medical therapy alone, the production of acid in the stomach is suppressed, but the actual problem of reflux remains. The most appropriate long-term therapy for GERD is to restore the body's physiological barrier to correct the cause of reflux itself," said Horgan, the first surgeon in the western United States to implant the device in this clinical trial.

"I decided to participate in this clinical trial surgery because it may be a permanent, structural way of addressing the problem," said Gina Levine, age 43, who has suffered from GERD for more than 18 years. "I like the minimally invasive approach to this procedure and that it can be reversed if necessary."

And here's the information about the procedure, from a Torax Medical website:

The LINX™ procedure is performed by a surgeon using a minimally invasive surgical technique, called laparoscopy. The device is placed around the distal esophagus, just above the stomach, in the area of the Lower Esophageal Sphincter (LES).

Once the device is placed it will begin working immediately; magnetic attraction between the beads helps to keep the lower esophageal sphincter closed to prevent reflux, but will open to allow swallowing or the release of higher gastric pressures.

Following the procedure, under physician guidance, patients should be able to resume normal diet and will typically resume normal activities in less than a week.

Our guess is that the device will have to significantly outperform currently available therapies, such as open and Nissen fundoplications, before it is approved. But given the limited surgical therapeutic options nowadays, we really hope that the LINX Reflux Management System makes it through the trials and onto the surgical field.

For now, an empty trial page at ClinicalTrials.gov...

Product page: LINX™ REFLUX MANAGEMENT SYSTEM...

Read the UC press release here...

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