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New Products In Brief

Recent product approvals and launches

Torax Medical Inc.’s Linx reflux management system for treating gastroesophageal reflux disease (GERD) has gained PMA approval, FDA announced March 22. GERD is a chronic condition in which food or liquid in the stomach flows back into the esophagus. Linx is surgically implanted at the lower esophageal sphincter to keep it closed and prevent the backward flow of stomach contents. The device, which is composed of a ring-shaped, magnetized series of titanium beads, is approved for GERD patients who continue to have symptoms despite the use of maximum medical therapy for reflux. In January, FDA’s Gastroenterology and Urology Devices panel voted 9-0 that the device’s benefits outweigh the risks for treating GERD, despite concerns that the firm’s 100-patient pivotal study missed its primary efficacy endpoint and lacked a control group. (See [A#01120116017].) As a condition of approval, Shoreview, Minn.-based Torax will institute a training program to educate new users on patient selection, device implantation and post-procedural care, FDA noted.

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