(RxWiki News) A FDA panel has given unanimous support to LINX, an implantable device to treat chronic and severe acid reflux. That means LINX is one step closer to being available for US patients.
The LINX Reflux Management System is a flexible ring of titanium magnetic beads. It's implanted on the lower end of the esophagus to prevent stomach acid and food from rising.
The magnetic attraction between the beads work to resist the gastric pressure that causes acid reflux. But when people are eating, it allows food and liquids to pass into the stomach normally.
"Ask your doctor if LINX might work for your symptoms."
LINX is produced by Torax Medical, a medical device company based in Minnesota. The device has already been on the market in some European countries for two years.
It received a positive recommendation from the FDA Gastroenterology and Urology Devices Advisory Panel. The FDA typically follows the recommendations of its panel, giving Torax an optimistic outlook on approval.
The panel found that LINX was safe and effective for treating acid reflux in patients who have not responded to medication.
Acid reflux, also called gastroesophageal reflux disease, or GERD, affects about 19 million adults in America. LINX is intended for severe cases, and doctors typically try non-surgical methods such as weight loss and medications first.
The FDA panel's recommendation was based on a clinical trial involving 100 patients with severe GERD. On average, they had over 80 episodes of heartburn per week, and had suffered from symptoms for 13 years.
The researchers running the trial tested the patients' acid levels in their esophagus before and after LINX was implanted. Acid levels fell by at least 50 percent in over half the patients.
Additionally, the patients reported major improvements on quality-of-life surveys.
Side effects included difficulty swallowing for as long as six months, and pain. Five patients had their implant removed.
LINX is not recommended for patients who need MRI scans, due to the magnetic nature of the beads.
Torax plans a follow-up study of 200 patients to test LINX's long-term safety and effectiveness.