A vote of 9-0 was casted on January 11 from the the FDA’s Gastroenterology and Urology Devices Panel to endorse approval on a device which will treat severe heartburn, otherwise known as gastroesophageal reflux disease (GERD).
The device was tested in clinical trials at the Keck School of Medicine of the University of Southern California. John Lipham is associate professor of surgery at USC and led the clinical investigation.
Lipham integrated the clinical trials of this new device as a part of his ongoing studies to find new ways to treat acid reflux or GERD.
“This device is a huge advance for the treatment of reflux, which affects millions of people in the United States. In fact, I have a list of patients waiting for it to be implanted,” Lipham was quoted on USC’s website.
The device was created by Torax Medical, Inc. based in Minnesota. Made up of magnetic, titanium beads, the bracelet-like device is implanted around the end of the esophagus near the lower esophageal sphincter valve. When this valve is weakened, acids from the stomach are able to reflux up into the esophagus, thus causing GERD to develop over a period of time.
According to the American College of Gastroenterology, more than 60 million Americans experience heartburn at least once a month and more than 15 million experience heartburn symptoms everyday.
With 15 to 20 minutes needed for implantation of the device, the procedure is almost completely outpatient, whereas acid reflux disease is more commonly treated via a surgical procedure. This procedure calls for the esophagael sphincter to be reconstructed. This invasive procedure results in the inability to belch or vomit and has been shown to lead to further bloating or gastro issues.
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