Study confirms bracelet-like device for acid reflux safe, effective 5 years after implantation

For nearly the past 50 years, primary treatment for acid reflux in the United States has included medications meant to dilute acid that regurgitates from the stomach, as well as a risky procedure that involves wrapping part of the stomach around a lower esophageal muscle.

But in 2012, the Food and Drug Administration (FDA) approved the implantation of a removable device that strengthens this weak muscle at the end of the esophagus, which is the main cause of acid reflux, or gastroesophageal reflux disorder (GERD). In June, research published in the journal Clinical Gastroenterology and Hepatology suggested  the device, called the LINX, is safe and effective in patients for up to five years— prompting researchers, who say it’s the longest-studied device for the ailment, to recommend the device as a first-line treatment for GERD.

“The average reflux patient gets by on medication,” lead study author Dr. Bob Ganz, chief of gastroenterology at Abbott Northwestern Hospital and associate professor of medicine at University of Minnesota, told FoxNews.com. “But medication doesn’t fix the reflux defect; it’s just taking the acid away. This device fixes the problem in a very natural way.”

The LINX device, which looks like a bracelet and is made with medical-grade titanium beads, each with a magnetic core, is about the size of a ring finger in diameter. It’s surgically tunneled into the body and clasped around the lower esophageal sphincter, where it physiologically helps the muscle open and contract before and after food is swallowed. By correcting that weak muscle, the device effectively prevents the regurgitation of stomach acid from racing up through the esophagus.

“People with [acid] reflux are really quite miserable,” Ganz said. “They can’t eat the way they want, sleep the way want, they can’t eat late at night, and often have to sleep sitting up in chair.”

An estimated 60 million Americans suffer from some type of GERD, which is a condition is marked by that weak lower esophageal sphincter, the muscle close to the upper part of the abdomen that facilitates the transport of food from the esophagus to the stomach. A normally functioning sphincter relaxes and opens while swallowing then closes afterward, but among GERD patients this muscle is too relaxed, causing the regurgitation of stomach acids that aid digestion. When those harsh chemicals splash the esophagus, at minimum they cause heartburn, chest pain and the feeling of a lump in the throat— but at worst, they can cause ulcers, esophagitis and mutations in the sensitive lining of the esophagus, leading to Barrett’s esophagus, a precancerous condition.

Doctors aren’t sure what causes GERD but know certain foods— like chocolate and caffeine— can contribute to the weakening of the lower esophageal sphincter, and that people who are overweight are also at an increased risk. The condition affects people young and old, but infants diagnosed with GERD often outgrow it.

People ages 21 and older who are not pregnant, do not have a large-hiatal hernia, have not undergone previous esophageal surgery, and are not allergic to metal are eligible to have the device implanted. Patients with Barrett’s esophagus may have the LINX implanted with their doctors’ approval.

The St. Paul, Minnesota-based company that manufactures the LINX device, TORAX Medical, estimates between 3,000 and 5,000 patients have been implanted with the mechanism since 2012, said Todd Berg, the CEO of TORAX. Berg would not reveal exact sales numbers of the device because TORAX is a privately owned company, but he said that, roughly, since 2012 the company has seen its sales of the LINX double each year.

Offering another option for GERD patients

Prior to the FDA’s approval of the LINX device, GERD patients who were dissatisfied with medication commonly turned to a procedure called Nissen fundoplication, which involves wrapping part of the stomach around the the lower esophageal sphincter to strengthen it and prevent acid regurgitation. That operation is good for patients with severe acid reflux, but it sometimes prevents patients from belching or vomiting, said C. Daniel Smith, an esophageal surgeon at Buckhead Surgical Associates, in the Atlanta area, and a medical director for TORAX Medical.

“One of the appealing things about [the LINX device] for someone like me who has been offering surgery for reflux for over 20 years is its absence of side effects,” Smith said. “What happens with the stomach wrap is you dry-heave— even the force of vomit isn’t strong enough to open it up. This device will open up and allow patients to vomit and belch— that’s what’s been so appealing.”

After the implantation of the LINX, which takes about 30 to 45 minutes, and is usually done on an outpatient basis, patients don’t feel it any more than a patient with a knee replacement would.

“[The tissue in the esophagus] takes a while to heal, so patients will feel food hesitate and push through the device and go through the stomach,” Smith, who has implanted at least 120 patients with the LINX device, told FoxNews.com. “It’s not painful; it’s more of awareness until it’s completely healed.”

Jodi Lech, a 41-year-old oncology pharmacist in Pittsburgh, Pennsylvania, had the LINX implanted in June 2013. She said her GERD, which she’d been coping with for nearly 10 years prior, caused her to be reliant on proton pump inhibitors (PPIs), the most common treatment for the condition on a daily basis, and affected her sleep.

Although there was an adjustment period with the device, which required her to chew and swallow slowly, she said the results regarding her sleep and energy levels were instantaneous.

“I remember that first week, thinking, ‘This is amazing,’” Lech, a mother of one, told FoxNews.com. “I didn’t realize I wasn’t sleeping … but I remember sleeping very well, and I continued to sleep very well— for that whole first week.”

Validating the effects of the LINX

“This is the best studied device in the field of anti-reflux devices,” said Ganz, whose practice has focused on the invention, implantation and study of esophageal devices. “There are almost no studies [in this field] that go beyond a year, and this is a study that had predefined endpoints and was an FDA-approved study. The follow-up was rigorous, and had objective and subjective endpoints. For all those reasons, we think this is the best.”

The study was conducted at more than a dozen research centers, and enrolled 100 people ages 18 to 85 with classic acid reflux symptoms, including heartburn at minimum. Fifteen patients dropped out of the study over that five-year period.

All of the participants either had seen no success with PPIs or were dissatisfied with those medications. Participants also all had hiatal hernias, which occur when part of the stomach pushes up through the diaphragm muscle that were 3 centimeters or less in size. Hiatal hernias can cause GERD.

At the beginning of the study, patients were given a GERD-HRQL questionnaire, and were evaluated for GERD signs and symptoms. Researchers followed up with them on a yearly basis with endoscopies, barium swallows and pH testing.

At the end of the five-year study period, objective data revealed the majority of patients’ pH scores were normalized, which suggested the device was effective at suppressing acid, and subjective data indicated 85 percent of the participants had stopped taking daily medication. Heartburn was reduced to about 12 percent from 89 percent at the beginning of the study, and regurgitation was reduced to about 1 percent compared to 57 percent at baseline.

“We were surprised at how well it did,” Ganz said. “For the properly selected patient this is almost the perfect reflux device.”

Ganz noted that about 7 percent of the participants had to have the device removed. For some, it failed, but for others it caused dysphagia, or difficulty swallowing, but he said that this incidence was not statistically significant at the end of the study compared to the beginning. After the device is removed, patients don’t see any anatomical change to their bodies.

Senior study author Dr. John Lipham, chief of upper GI and general surgery at the Keck School of Medicine at the University of Southern California, and a medical director at TORAX, said potential risks of the procedure include damaging the esophagus and the stomach.

“We haven’t seen any operative complications to date with putting the device in, although it is general anesthesia.  With anything, there’s always a risk of bleeding, infection, anesthetic compilations and even death,” Lipham told FoxNews.com.

Lipham helped develop the LINX about 10 years ago and studied how it worked in pigs before the device was evaluated for efficacy in a previous pilot study involving 44 patients, and then in the current study for safety.

“What we found in this trial and in the pilot study is that it was incredibly good at controlling regurgitative symptoms,” he said. “Upwards of 99 percent of the patients had control of regurgitative symptoms after placement of the LINX, and I don’t think any of us anticipated it would be that good.”

He added that the lack of side effects was also surprising, as well as the device’s erosion rate. After eight years, in those patients who participated in the pilot study, the device eroded by only .2 percent, which was at a slower rate than researchers hypothesized, he said.

While clinical trials of the LINX involved patients with a range of GERD symptoms, those individuals who have larger hiatal hernias and more severe cases of GERD have not yet been studied outside of a clinical setting.

“The clinical trials were designed to match every clinical trial that came before, and every GERD trial limits it to patients with small hernias and not a lot of damage to their esophagus,” Lipham noted. “Because of that, we only have limited experience on patients outside the clinical trials. I’ve [implanted] 30 or 40 patients [with the LINX] that appear to have more advanced reflux and more severe hiatal hernias, but that data needs to be validated. We need to do a small trial on those patients that are different from the clinical trial patients.”

But, he added that, based on his observations of other devices, for the vast majority of patients with those characteristics of the study group the LINX is the best technology available.

Lipham has participated in trials of other devices to treat GERD, including the Stretta, which uses radiofrequency energy to remodel and strengthen muscle tissue; as well as the EsophyX, which involves a partial fundoplication to treat GERD; and the ENTERYX, a previously performed procedure for GERD that the FDA recalled in May due to safety concerns.

“In my experience, none of those three have even come close to what we’ve seen so far with the LINX,” Lipham said.

For Lech, the pharmacist in Pittsburgh, the effects of the LINX were made clear to her six months ago, about a year and a half after she got the device implanted. It was then that she opened her medicine cabinet at home and noticed all of her once-daily medications for GERD—the TUMS, the Zantac and Nexium, none of which she had touched since she got the LINX implanted— were expired.

“It all got pitched,” she said.