FDA Panel Backs New Device for Chronic Heartburn
LINX Would Be Used in Patients With GERD That Doesn’t Respond to Drugs
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Clinical Trial Patients Had Suffered From GERD for Years continued...
The acid level in the patients’ esophagus was assessed before and 12 months after LINX was implanted via minimally invasive “keyhole” surgery. Just over half of the patients saw their acid level fall by at least one-half.
Improvement on a subjective quality-of-life assessment -- which asked such questions as when and how often heartburn occurred and whether it kept them up at night -- was even greater, both at 12 months and 24 months after surgery, Venkataraman-Rao said.
But because the study did not have a comparison group that did not get the device, there’s “no way of knowing whether subjects would have improved on their own,” Venkataraman-Rao said.
Three-quarters of the implanted patients experienced side effects, the most common being difficulty swallowing, which in some cases took six months or more to resolve, she said. The second most common side effect, reported by a quarter of the patients, was pain. The implant had to be removed from five of the patients.
Because LINX is magnetic, patients who might need MRI scans would not be eligible to have it implanted.
Torax says it plans to conduct a follow-up study of 200 patients to confirm the device’s long-term safety and effectiveness.
Advisory committee member Steven Schwaitzberg, MD, an associate professor of surgery at Harvard, urged that the company follow patients for at least 10 years. “I think it’s going to be an obligation that we have to the public,” Schwaitzberg said.
“I’m really worried about safety,” he said, noting that LINX could stay in some patients for as long as half a century.