Torax Medical rolls out LINX procedure for GERD patients to select specialists

TAMPA—A few dozen approved surgeons specializing in gastro-esophageal reflux disease or gastro-intestinal surgery across the nation are offering a revolutionary procedure for patients with gastro esophageal reflux disease (GERD). It’s so new; many primary care physicians and some specialists aren’t aware of it as an option.

“The FDA approved the LINX Reflux Management System two years ago, but when the New England Journal of Medicine published an article discussing the efficacy of the system … then healthcare providers, patients and the media took notice,” said Gopal Grandhige, MD, a board-certified, Yale fellowship-trained, laparoscopic general surgeon with Suncoast Surgical Associates in Tampa, director of the Tampa Bay Reflux Center, and a LINX-approved surgeon.

Torax Medical opted to launch the procedure nationwide at approved centers, one or two per state. The company develops and markets products designed to restore human lower esophageal sphincter function via its technology platform, Magnetic Sphincter Augmentation (MSA), which uses attraction forces to augment weak or defective sphincter muscles to treat GERD that often irritates the esophagus, causes heartburn and other symptoms. Left untreated, reflux could lead to serious complications, such as esophagitis, stricture, Barrett's esophagus and esophageal cancer.

“Torax Medical has been extraordinarily concerned with patient outcomes and patients’ well-being by only releasing the LINX device to centers that do a lot of reflux work, in order that the proper evaluation and appropriate patients are chosen for this minimally invasive procedure,” said Grandhige.

The LINX System’s new device is a quarter-sized flexible band of magnets encased in tiny titanium beads. The magnetic attraction between the beads helps keep a weak esophageal sphincter closed to prevent reflux. Implanted around a weak sphincter just above the stomach, the minimally invasive procedure typically takes less than an hour to complete. Most patients even go home the same day of the procedure.

“The force of swallowing breaks the magnetic bond to allow food and liquid to pass through, and then the magnetic attraction closes the lower esophageal sphincter back to form a barrier,” said Grandhige.

A procedure developed in the 1990s called the laparoscopic Nissen fundoplication currently is the most common procedure performed for heartburn.

“The problem with the procedure is that each surgeon performs it differently because it’s best used for a completely dysfunctional sphincter,” said Grandhige. “In this procedure, the top part of the stomach – the fundus – is wrapped around the lower esophagus to improve the reflux barrier. In patients who have severe reflux, this procedure works very well and has minimal side effects of bloating and dysphagia. The problem with the Nissen fundoplication is that it works too well in those patients with mild to moderate reflux, and these patients may report gas bloating because of the decreased ability to belch.

The LINX Reflux Management system standardizes the surgery, leading to more reproducible results, he said.

Three years after sphincter augmentation with the LINX System, the majority of treated patients were able to substantially reduce or resolve their reflux symptoms, while also eliminating their use of reflux-related medications, according to the New England Journal of Medicine summary.

In 100 percent of patients, severe regurgitation was eliminated, and nearly all patients (93 percent) reported a significant decrease in the need for medication. Ninety-four percent reported satisfaction with their overall condition after having the LINX System procedure, compared to 13 percent before treatment while taking medication.

“Surgical options such as the Nissen fundoplication offer a static solution to the treatment of reflux which is required in late-stage disease,” said Grandhige. “The LINX procedure is dynamic because opening and closing simulates the normal sphincter, except you’re keeping it closed so you don’t have reflux. Now we have a choice for patients that we can tailor-make the surgical approach to this problem.”

The Tampa Bay Reflux Center offers three procedures for reflux: one endoscopic (incision-less) procedure and two laparoscopic procedures.

“By offering various options, we’re able to tailor an appropriate treatment for our patients, without pigeon-holing all patients into one option,” said Grandhige.

Like Nissen fundoplication, the procedure is done laparoscopically through five small punctures in the abdomen.

“Once we’re in the OR, we can decide which procedure the patient is better suited for, depending on anatomy,” he said. “For example, the LINX procedure cannot be done if the patient has a hiatal hernia larger than three centimeters.”

Another patient benefit is a quicker return to eating solid food.

“We try to get LINX patients to eat regular food right away to train the device,” he said. “With the Nissen procedure, they’re on a prescribed diet for at least two weeks.”

Because the procedure is new, insurance coverage varies by provider and is usually approved on a case-by-case basis, but Medicare has started to approve a portion of the procedure.

Florida LINX-approved surgeons:

• Florida Hospital Celebration Health

James C. Rosser, MD

www.floridahospital.com/contact

• Florida Hospital Orlando

Steve Eubanks, MD

www.floridahospital.com/contact

• Mayo Clinic in Florida, Jacksonville

Kenneth R. Devault, MD

C. Daniel Smith, MD

• Tampa Bay Reflux Center

Brandon, Tampa, and South Tampa

Gopal Grandhige, MD