AUSTIN, Texas--(BUSINESS WIRE)--Apollo Endosurgery, Inc. (“Apollo”) (Nasdaq:APEN), a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, announced Digestive Disease Week presentation of a meta analysis that concluded fluid-filled balloons, like the ORBERA® Intragastric Balloon, have superior weight loss results to gas-filled balloons.
This meta-analysis reviewed twenty-one (21) randomized clinical trials with 877 patients, including trials for all three FDA-approved intragastric balloons and assessed weight loss metrics at 6 and 12 months (6 months after balloon removal). The study was led by physicians at the Mayo Clinic (Rochester, MN), Massachusetts General Hospital (Boston, MA) and Digestive Center for Diagnosis & Treatment (Damascus, Syrian Arab Republic).
The study showed fluid-filled balloons resulted in 60% more total body weight loss at 6 months compared with gas-filled balloons, with SUCRA (Surface Under the Cumulative Ranking) probabilities demonstrating superiority of liquid-filled intragastric balloons at all time points. ORBERA had the highest average weight loss of any of the intragastric balloons included in the meta-analysis.
The authors attributed the greater weight loss with ORBERA and fluid filled balloons to their impact on the gastric emptying process. The authors theorize that the gas-filled balloons are less effective because of their “inability to significantly delay gastric emptying.” The authors also reported that all balloon types are associated with similar adverse events although fluid-filled balloons maybe associated with more symptoms and worse tolerance given their more pronounced impact on gastric emptying.
“Gastric emptying is the key to how ORBERA helps patients lose weight. When a patient has an ORBERA balloon in their stomach it acts like a valve that slowly allows food they eat to pass through their stomach. Without a balloon a normal meal will typically pass through a patients stomach in 20-30 minutes. Now with an ORBERA balloon in their stomach, we have data that a large portion of that meal would still be in their stomach 2 hours after eating. This delayed emptying helps patients feel full, helps them learn proper portion control and most importantly helps them lose a clinically significant amount of weight,” said Dr. Christopher Gostout, MD, Chief Medical Officer at Apollo.
The abstract for this study can be found at https://ep70.eventpilot.us/web/page.php?page=IntHtml&project=DDW18&id=2916725
ORBERA® is an incision-less, non-surgical weight loss solution designed for adult patients suffering from obesity, who are not appropriate for or considering invasive 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 to 30 minutes and the patient can generally go home the same day. At six months, through another non-surgical procedure, the ORBERA balloon is deflated and then removed.
Once the balloon is in place, the patient receives an individually tailored support program through the ORBERA Managed Weight Loss System team of experts to help keep them motivated, coordinate their program and help them work through weight loss barriers to meet their long-term weight loss goals. Coaching takes place over 12 months, even though the balloon is removed after six months. The program is designed to help the patient develop sustainable, healthy habits that will help keep weight off over time.
For more than 20 years, the global medical community has been using intragastric balloons from the makers of ORBERA to help thousands of people lose weight. More than 295,000 ORBERA balloons have been distributed worldwide in over 70 countries.
For additional information regarding ORBERA, please visit www.orbera.com.
For full safety information please visit www.orbera.com/dfu, talk with your doctor, or call Apollo Customer Support at 1-855-MYORBERA.
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical device company focused on less invasive therapies for the treatment of obesity, a condition facing over 600 million people globally, as well as other gastrointestinal conditions. 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 ORBERA® Intragastric Balloon, and the LAP-BAND® Adjustable Gastric Banding System.
Apollo’s common stock is traded on Nasdaq Global Market under the symbol "APEN." For more information regarding Apollo, go to: www.apolloendo.com.
© 2018 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, 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 and other factors detailed from time to time in the reports Apollo files with the Securities and Exchange Commission, or SEC, including its Form 10-K for the year ended December 31, 2017 and it Form 10-Q for the three months ended March 31, 2018. 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.