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FDA panel backs implantable device to control GERD
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An implantable device to relieve the symptoms of pathologic gastroesophageal reflux disease has been unanimously approved by an FDA advisory panel.
The LINX Reflux Management System (Torax Medical) is an expandable band of connected titanium beads, each containing a magnetic core. Placed laparoscopically around the gastroesophageal junction, the beads augment an ineffective esophageal sphincter, according to the manufacturer.
The nine-member advisory panel debated some concerns about the potential risk of dysphagia but agreed that the clinical benefit outweighed the risk.
A trial included 100 patients implanted with the device. The primary endpoint was defined as pH normalization or improvement of at least 50% in at least 60% of patients at 1 year. The treatment group achieved a 64% success rate, according to the manufacturer.
One secondary endpoint was improvement of at least 50% in a standard quality of life survey in at least 60% of patients after 1 year. The treatment group achieved a 92% success rate.
Another secondary endpoint was defined as a reduction from baseline in daily proton pump inhibitor use by at least 50% in at least 60% of patients at 1 year after implantation. The treatment group achieved a 93% success rate on this measure, according to the manufacturer.
Regarding safety, nine serious adverse events occurred in six patients.