Two months after a regulatory panel recommended the approval of the Linx Reflux Management System, the U.S. Food and Drug Administration approved the minimally invasive device developed by Torax Medical of Shoreview, Minnesota to treat acid reflux. In announcing the premarket approval Thursday, the FDA said that Torax will “institute a required training program to educate new users on patient selection, device implantation and post-procedural care of patients” as a condition of approval.
The Linx Reflux Management System uses a small, flexible band of interlinked titanium beads wrapped around magnetic cores, which is laparoscopically implanted around the esophageal sphincter. The magnetic attraction is designed to resist the opening of the sphincter to gastric pressure, thereby preventing the entry of stomach acids into the esophagus. At the same time, much higher pressures from swallowing can overcome the magnetic pull and allow food and liquid to pass normally into the stomach.
It is intended for patients who experience severe and ongoing acid reflux despite being treated with drugs and other therapies.
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FDA noted that the most common adverse effects associated with the device were difficulty swallowing, pain when swallowing food, chest pain, vomiting and nausea.
It also warned that patients electing to undergo the procedure will no longer be able to undergo a magnetic resonance imaging (MRI) because the magnetic titanium beads of the Linx system will interfere with the machine and may cause harm to the patient.
While Torax has been awaiting U.S. approval, the Linx anti-reflux treatment has been available in Europe since 2010.
The U.S. approval will come as good news to both the company and its investors who have poured in millions of dollars. Previously, a spokeswoman would not reveal how much money the company has raised, but regulatory filings dating back to 2003 show that it is at least $35.5 million. Investors of the company include Sanderling Ventures, Thomas McNerney & Partners, Accuitive Medical Ventures and Kaiser Permanente Ventures.
Brian Mower, the company’s vice president of finance, could not be immediately reached.
[Photo Credit: Surachai]
