Acid reflux disease was making Jeff Pugh's life miserable.
Like millions of Americans, he took medications to suppress and counteract the digestive juices that backed up from his stomach into his esophagus. But drugs don't address a basic underlying problem: the esophageal muscle that acts as a valve between the stomach and esophagus gets too weak or loose to shut out the acids.
For Pugh, 45, of West Norriton, the fix was a recently approved device - a tiny necklace of magnetic titanium beads that encircle the lower esophagus. The beads separate slightly during the pressure of swallowing to allow food to pass, then close to prevent the backwash of acid.
Pugh had the LINX Reflux Management System implanted in June during a minimally invasive, one-hour surgery at Einstein Medical Center in Philadelphia. It freed him from reflux symptoms that included excruciating heartburn, a sleep-disrupting nighttime cough, and esophageal bleeding. It also liberated him from daily doses of an antacid, a proton pump inhibitor, and other drugs.
"I went into the hospital in the morning, came home at 3 p.m., and that night I had roast beef, a baked potato, and asparagus," recalled the Continental Bank commercial-loan executive. "I had the procedure on a Friday and was back to work on Monday. This really was a godsend."
Not all patients have such an easy adjustment. In the pivotal, five-year study that led to Food and Drug Administration approval in March 2012, six of the 100 patients had to have the device removed because of persistent difficulty with swallowing or other complications.
But the ability to remove the LINX is an advantage. The only other surgical treatment for unmanageable reflux, called fundoplication, involves wrapping the upper portion of the stomach (the fundus) around the esophagus and sewing it into place. The surgery is difficult or impossible to reverse, and can have side effects such as bloating, an inability to belch or vomit, and swallowing problems.
Einstein bariatric surgeon Ramsey Dallal, who performed Pugh's LINX procedure, said only a small minority of gastroesophageal reflux disease (GERD) patients had such severe, hard-to-control reflux that they were candidates for fundoplication or the new device.
"But GERD is so common," he added, "that we're talking hundreds of thousands of people."
For them, GERD can lead to serious complications. They may develop asthma or breathing problems if the acid goes into the lungs. Or Barrett's esophagus, a tissue abnormality that is a risk factor for esophageal cancer. Or chronic hoarseness.
"I had a patient last year who could barely speak and was going to get fired because he couldn't talk on the phone," Dallal said. "After the [LINX] operation, his voice was completely normal."
The LINX is the invention of Torax Medical Inc., a Shoreview, Minn., company created to find a way to treat what doctors call an "incompetent esophageal sphincter."
"We knew reflux disease is based on patients' having a mechanical defect," said Torax CEO Todd Berg. "But when you start from scratch to develop a device to fix the defect, it's not obvious what the parameters need to be."
It took more than 100 animal studies to figure out how much magnetic attraction would allow the titanium beads to separate during swallowing and spring back.
Because of the metal beads, LINX patients cannot have MRI exams. They may also still need to take reflux medications.
The LINX costs the same as fundoplication - $15,000 to $20,000 - but insurers are balking at covering it, Berg said.
"Unfortunately, payers say, 'We still think it's investigational,' " Berg said. "When we appeal the refusal, we win more than we lose."
Einstein, one of 14 centers in the pivotal study, is the only hospital in the Philadelphia area now offering the LINX. But the company, Berg said, hopes it will be more widely available as more physicians are trained to implant the device.