The FDA's Gastroenterology-Urology Devices Panel voted unanimously that LINX's Reflux Management System, a laparoscopically implanted device designed to treat gastroesophageal reflux disease, has a favorable risk-benefit profile and was safe and effective, according to an FDA report.
The system is a sterile, single-use device designed to support a weak lower esophageal sphincter and prevent reflux. Consisting of titanium beads with a magnetic core strung together on a titanium wire, the device is placed around the gastroesophageal junction at the LES. The magnetic beads rest against each other to prevent the LES from opening. The magnetic attraction is disrupted when the patient swallows to allow food to pass through. The panel did not vote specifically on whether to recommend approval.
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The system is a sterile, single-use device designed to support a weak lower esophageal sphincter and prevent reflux. Consisting of titanium beads with a magnetic core strung together on a titanium wire, the device is placed around the gastroesophageal junction at the LES. The magnetic beads rest against each other to prevent the LES from opening. The magnetic attraction is disrupted when the patient swallows to allow food to pass through. The panel did not vote specifically on whether to recommend approval.
Related Articles on Gastroenterology:
Fecal Immunochemical Test Now Available to Patients at Home
Global Gastrointestinal Device Market to Reach $14.6B
Gastrointestinal Endoscopic Device Market Expected to Hit $2.7B by 2018