FDA Approves Revised Labeling for Orbera Intragastric Balloon System

Apollo Endosurgery’s Orbero intragastric balloon system received approval for updates to its U.S. labeling that include new physician directions for use, physician training and patient directions for use.

The system’s last labeling update occurred on June 6, 2017 and included information about adverse events of acute pancreatitis and spontaneous hyperinflation, which did not occur during its U.S. pivotal study.

The revised directions for use include specific U.S. rates for acute pancreatitis, spontaneous hyperinflation, gastric and esophageal perforation and aspiration.