It looks like an expensive bracelet, but the contraption laced in titanium beads gets placed around the esophagus rather than the wrist.
The LINX Reflux Management System is a new treatment for acid reflux, a digestive order that causes heartburn, nagging cough and other chronic symptoms in 10 million to 20 million U.S. patients. The condition occurs when a weak valve where the esophagus meets the stomach, known as a sphincter, won't close properly, allowing bile and acid to wash up.
Some doctors say the device, approved by the FDA last year, shows promise as an alternative for patients who don't find relief from drugs that reduce acid in the stomach, but don't want to get major surgery. In one such surgery to treat the disease — a procedure called Nissen fundoplication — the top of the stomach is wrapped around the esophagus to tighten the sphincter.
The LINX ring takes on the job of the sphincter. Surgeons wrap the device around the base of the esophagus through non-invasive laparoscopic surgery.
The beads on the device have magnetic cores which pull together to keep the esophagus closed but open up when food is detected. The device pops shut as the food moves farther down the digestive tract.
Anne Arundel Medical Center will insert the device in its first patients in coming weeks.
"Anything that is a shorter, simpler operation is good for the patient," said Dr. Adrian Park, chair of the department of surgery at Anne Arundel Medical Center, who added that there was need for a surgery that wasn't as invasive.
Park and other doctors said that early studies on the device, which covers about three years of use, are promising.
One study, published in the New England Journal of Medicine in February, looked at 100 people who received a magnetic sphincter device. The majority of the patients saw their symptoms reduced significantly or completely. Most also had less need to take medication.
"The early results show that the device really reduces acid exposure after it is put in," Park said. "It brings it down almost to a normal range.
The study cautioned that follow-up studies were needed to determine the long-term effects of the treatment.
One Johns Hopkins doctor said research has raised some questions about the procedure. Some patients had needed the device removed, while others had trouble swallowing after having it inserted, said Dr. John O. Clarke, clinical director of the Johns Hopkins Center for Neurogastroenterology and an assistant professor of medicine in the division of gastroenterology & hepatology at the Johns Hopkins University. He is also concerned about the long-term effects.
"It wouldn't be shocking if we find in 15 years there is slippage or other adverse reactions that were not expected," Clarke said.
But Clarke said the device's preliminary results are mostly positive and Hopkins likely will use it in the near future. One physician already is trained in how to use it, Clarke said.
"I think the good will outweigh the negatives at this point," he said.
Acid reflux turns into a debilitating condition for some patients, Anne Arundel Medical Center's Park said. Some people can't sleep, have trouble swallowing and suffer with uncontrollable heartburn.
In severe cases, acid can damage the esophagus and lead to a condition called Barrett's esophagus. Damage to the esophagus causes abnormal cells to develop and its lining to become more like that of the intestinal wall. The condition can lead to esophageal cancer.
Drugs on the market treat acid reflux by neutralizing acid in the stomach or blocking the production of acid. Studies have found that 40 percent of people on those drugs do not get enough relief from symptoms. The drugs also can lead to bone thinning.
"It doesn't speak to the underlying condition, the valve that is not working," Park said.
The Nissen surgery also isn't always effective, Park said. Success often depends on the expertise and experience of the surgeon.
Doctors said it is good to have a variety options that work on a variety of patients.
"I think it will have a niche within the treatment options," Hopkins' Clarke said about the LINX surgery.
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