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Apollo Endosurgery Announces FDA Approval of Revised Labeling for the ORBERA® Intragastric Balloon System
Jun. 05, 2018 09:26AM PST
Medical Device InvestingApollo Endosurgery (Nasdaq: APEN) a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, announced today that the United States Food and Drug Administration (FDA) has approved updates to the ORBERA® Intragastric Balloon System’s U.S. labeling including a new Physician Directions for Use (DFU), Physician Training, and Patient Directions for Use. As …
Apollo Endosurgery (Nasdaq: APEN) a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, announced today that the United States Food and Drug Administration (FDA) has approved updates to the ORBERA® Intragastric Balloon System’s U.S. labeling including a new Physician Directions for Use (DFU), Physician Training, and Patient Directions for Use.
As quoted in the press release:
Apollo’s last ORBERA labeling update occurred on June 6, 2017 and included information regarding adverse events of acute pancreatitis and spontaneous hyperinflation, which were not seen during the ORBERA United States pivotal study. The newly revised and approved labeling announced today provides updates for these two events and also adds information regarding the risks of gastric and esophageal perforation, aspiration, and death. The table below summarizes the global rate of occurrence for these adverse events as included in the revised DFU (data as of March 31, 2018) and in the previous DFU (data as of March 31, 2017).
