AUSTIN, Texas--(BUSINESS WIRE)--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.
ORBERA® is an incision-less, non-surgical weight loss solution designed for adult patients suffering from obesity, who are not appropriate for or considering surgery, but for whom diet, and exercise or pharmaceutical interventions have not worked.
In a non-surgical (endoscopic) procedure, the thin and deflated ORBERA balloon is placed into the stomach. It is then filled with saline until it’s about the size of a grapefruit. The procedure typically takes about 20 minutes and the patient can generally go home a few hours later. After up to 6 months, through another non-surgical procedure, the ORBERA balloon is deflated and then removed.
Once the balloon is in place, the patient works with their physician and their staff in a formal lifestyle modification program to meet their long-term weight loss goals. Coaching takes place over 12 months while the balloon is in place. The program is designed to help the patient develop sustainable, healthy habits that will help keep weight off over time.
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical technology company focused on less invasive therapies to treat various gastrointestinal conditions, ranging from gastrointestinal defect repairs to the interventional treatment of obesity. Apollo's device-based therapies are an alternative to invasive surgical procedures, thus lowering complication rates and reducing total healthcare costs. Apollo's products are offered in over 70 countries today and include the OverStitch™ Endoscopic Suturing System, the OverStitch Sx™ Endoscopic Suturing System, and the ORBERA® Intragastric Balloon.
Apollo’s common stock is traded on Nasdaq Global Market under the symbol "APEN". For more information regarding Apollo Endosurgery, go to: www.apolloendo.com.
© 2019 Apollo Endosurgery, Inc. All rights reserved. Any third-party trademarks used herein are the property of their respective owners.
Cautionary Note on Forward-Looking Statements
Certain statements in this press release are forward-looking statements that are subject to risks and uncertainties that could cause results to be materially different than expectations. Important factors that could cause actual results to differ materially include: reports of adverse events related to our products, outcomes of clinical studies, developments in medical technology, regulatory approvals and extensive regulatory oversight by the FDA or other regulatory bodies, unfavorable media coverage related to our products or related procedures, reimbursement decisions by private or government payors, physician adoption and recommendations of procedures utilizing our products as well as other factors detailed in Apollo’s periodic reports filed with the Securities and Exchange Commission, or SEC, including its Form 10-K for the year ended December 31, 2018 and its Form 10-Q for the three months ended March, 31, 2019. Copies of reports filed with the SEC are posted on Apollo’s website and are available from Apollo without charge. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Apollo disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.