Apollo Endosurgery, Inc. (“Apollo”) (Nasdaq:APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures announced today that it has received FDA approval for its proposed labeling updates for the ORBERA® Intragastric Balloon System. The goal of the labeling updates is to improve patient safety and these will take effect immediately. The updated US Orbera Directions for Use is available here.
The labeling updates improve patient safety by providing further definition and guidance on the appropriate use of the ORBERA® Intragastric Balloon System and patient selection. The most notable safety labeling updates included:
- Clarification to contraindications. These changes clarified that the previous “hepatic insufficiency or cirrhosis” contraindication related to patients with acute liver failure and decompensated cirrhosis. The changes also clarified the types of previous gastric surgery that are contraindications.
- Added precautions related to patients who are taking anti-cholinergic or psychotropic medications that are known to delay gastric emptying.
- Updated US adverse event tables based on the current market surveillance data. There were no new categories of adverse events added and occurrence rates did not materially change.
- Other procedure technique-related edits were made to the instructions for use.
“‘Hepatic insufficiency or cirrhosis’ has been clarified so that it is not interpreted incorrectly as disallowing Orbera’s use in a broad spectrum of liver disease patients including non-alcoholic fatty liver disease (NAFLD) and its subtype non-alcoholic steatohepatitis (NASH),” said Dr. Christopher Gostout, Apollo’s Chief Medical Officer.
Approximately 100 million individuals in the United States are estimated to have NAFLD and weight loss is identified by the American Association for the Study of Liver Diseases in their patient treatment guidelines as one of the most effective treatments to stop and potentially reverse the progression of fatty liver disease.