Medical Devices
LINX™ Reflux Management System - P100049
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: LINX™ Reflux Management System
PMA Applicant: Torax Medical, Inc.
Address: 4188 Lexington Avenue, Shoreview, MN
Approval Date: March 22, 2012
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf10/P100049a.pdf
What is it? The LINX™ Reflux Management System (LINX device) consists of a series of titanium beads, each with a magnetic core, connected together with titanium wires to form a ring shape. The LINX device is surgically implanted around the lower end of the esophagus. It is used to treat gastroesophageal reflux disease (GERD) in patients who continue to have GERD symptoms despite the use of maximum medical therapy for the treatment of their reflux.
How does it work? The LINX device is implanted around the lower esophageal sphincter (a sphincter is a muscle that surrounds and closes a bodily opening) to strengthen a weak sphincter. Using the device helps to prevent the contents of the stomach from backing up into the esophagus (reflux). By restricting the flow of stomach contents into the esophagus, the patient will improve their heartburn symptoms and reflux (regurgitation) and may no longer require medicines to treat these symptoms.
Even though the LINX device helps to prevent stomach contents from flowing back into the esophagus, it does not prevent movement of food or liquids down the esophagus into the stomach. When the patient swallows, the pressure in the esophagus increases and the magnetic beads move apart on the titanium wires. As the beads move apart, the magnetic force decreases. This separation of the beads allows food or liquids to pass normally into the stomach. After the food or liquids have passed into the stomach, the magnetic beads return to the closed position.
When is it used? The LINX device is used in patients who continue to have symptoms of GERD, such as heartburn and reflux, despite maximum medical therapy (daily use of medicines such as proton pump inhibitors). It is intended to be used by patients who would be considered candidates for anti-reflux surgery.
What will it accomplish? The LINX device will help prevent abnormal amounts of acid from the stomach moving back into the esophagus. In a clinical study of 100 patients implanted with the LINX device, 64 patients either had normal amounts of acid in the esophagus or at least a 50% improvement in the amount of acid in the esophagus. Additionally, 92 patients had improvement in their GERD symptoms, so they felt better. The clinical study also found that 93 patients were able to reduce their medicines or no longer needed to take any medicines to treat their GERD symptoms.
The most common adverse events experienced by patients were difficulty swallowing (76 events in 68 patients) and some of the patients had their esophagus expanded (dilated). The second most common adverse event was pain (25 events in 24 patients).
Patients who have the LINX device should not be exposed to, or undergo, an MRI (Magnetic Resonance Imaging). Exposure to MRI could cause serious injury to the patient and the device may be damaged.
When should it not be used? The LINX device should not be used in anyone who may be allergic or is allergic to titanium, stainless steel, nickel, or iron (ferrous) materials.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.
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