The goal of the labeling updates is to improve patient safety and they will take effect immediately, according to the Austin, Texas-based company. The Orbera system and Reshape Lifesciences’ (NSDQ:RSLS) integrated dual balloon system were linked to 12 patient deaths from 2016 to mid-2018.
The labeling updates provide further definition and guidance on the appropriate use of Orbera and patient selection, according to the company. The labeling updates include:
- Clarification to contraindications. These changes clarify the previous “hepatic insufficiency or cirrhosis” contraindication related to patients with acute liver failure and decompensated cirrhosis. The changes also clarify the types of previous gastric surgery that are contraindications.
- Added precautions related to patients who are taking anticholinergic or psychotropic medications that are known to delay gastric emptying.
- Updated U.S. adverse event tables based on current market surveillance data. There were no new categories of adverse events added and occurrence rates did not materially change, according to the company.
- 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, in a news release.
The Orbera balloon device is designed to be placed in the stomach through the mouth in a minimally invasive endoscopic procedure and then filled with fluid, and stay in the stomach for a period of six months.
Apollo Endosurgery’s stock was up 2.13% to $3.83 on the news this morning.