FDA Panel Says LINX Implantable Device to Treat GERD is Safe, Effective

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.

Next Up in GI & Endoscopy

FDA Panel Says LINX Implantable Device to Treat GERD is Safe, Effective

Next Up in GI & Endoscopy

The 5 highest-paid gastroenterologists in Miami

Gastroenterologist named chair of Metro Health's department of medicine

Gastroenterologists' growing burdens

RCM trend report: How leaders can protect revenue + adapt to disruption

Next Up in GI & Endoscopy

The 5 highest-paid gastroenterologists in Miami

Gastroenterologist named chair of Metro Health's department of medicine

Gastroenterologists' growing burdens

Join the 40,000+ ASC leaders who start their day with Becker's