Apollo Endosurgery Announces Presentation of the Brazilian Intragastric Balloon Consensus Statement at ObesityWeek
Includes retrospective analysis of over 32,000 ORBERA cases demonstrating strong safety and efficacy of intragastric balloon therapy
AUSTIN, Texas–(BUSINESS WIRE)–Apollo Endosurgery, Inc. (“Apollo”) (NASDAQ:APEN), a leader in less invasive surgical medical devices for bariatric and gastrointestinal procedures, announced the presentation of the largest global review of intragastric balloons titled “Brazilian Intragastric Balloon Consensus after more than 40,000 cases” at ObesityWeek 2017 – the combined annual meetings for both American Society for Metabolic & Bariatric Surgery (ASMBS) and The Obesity Society (TOS).
This presentation reported the results of a consensus meeting held in Sao Paulo, Brazil in June 2016 of 39 endoscopists with up to 17 years of experience providing intragastric balloon therapy to patients. The group aggregated retrospective data on their experience with intragastric balloons in over 40,000 cases. The expert meeting was held to discuss and evaluate clinical and technical aspects of intragastric balloons (indications, contraindications, techniques, adverse events, multidisciplinary follow-up) with the aim of reaching a consensus on best practice guidelines based on scientific literature and their extensive experience. The threshold for inclusion in the meeting was a minimum experience of 300 intragastric balloon procedures.
Key data reported encompassed experience from 41,886 intragastric balloon procedures conducted by the endoscopists:
- Mean percentage total body weight loss of all patients was 18.4% (+/- 2.9%).
- ORBERA® was used in 78.2% (32,753) of the reported intragastric balloon procedures.
- Adverse event rate after the adaptation period was 2.5%, the most common being hyperinflation and device deflation.
- Of the five types of intragastric balloons discussed, ORBERA had the lowest incidence of adverse events at 2.0%.
- Early removal rate due to intolerance was 2.2%.
- There were twelve (<0.03%) deaths during the presence of an intragastric balloon, of which three (<0.01%) were considered device related.
“The Brazilian market has been one of the pioneers in intragastric balloon therapy and is today very advanced with over 40,000 patient experiences represented by those in attendance at the consensus,” said Dr. Manoel Galvao Neto, lead author of the study and Clinical Associate Professor of Surgery at Florida International University and Coordinator of the Esophaegeal Motility Lab at Hospital Estadual Mario Covas in São Paulo, Brazil. “The majority of the experience is with ORBERA and our conclusion was that intragastric balloons such as ORBERA lead to very satisfactory weight loss and a very low rate of adverse events.”
“This is a remarkable study that captures the experience of physicians who collectively have placed more than 40,000 intragastric balloons, the vast majority with our ORBERA balloon,” said Todd Newton, CEO of Apollo Endosurgery. “To our knowledge, it is the first of its kind regarding intragastric balloons and the results reinforce the very strong safety and efficacy profile of ORBERA.”
The full peer-reviewed manuscript (http://dx.doi.org/10.1016/j.soard.2017.09.528) of this study titled “Brazilian Intragastric Balloon Consensus (BIBC): practical guidelines based on experience of over 40,000 cases” was recently accepted for publishing by Surgery for Obesity and Related Diseases (“SOARD”), which is the official scientific journal of the American Society for Metabolic and Bariatric Surgery (“ASMBS”).
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 277,000 ORBERA® balloons have been distributed worldwide in over 80 countries.
For additional information regarding ORBERA®, please visit orbera.com.
For full safety information please visit 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 disorders. 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 80 countries today.
Apollo’s common stock is traded on NASDAQ Global Market under the symbol “APEN.” For more information regarding Apollo Endosurgery, go to: apolloendo.com.
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: developments in medical technology; regulatory approvals and extensive regulatory oversight by the FDA or other regulatory bodies; reports of adverse events related to our products; unfavorable media coverage about our products or related procedures; reimbursement decisions by private or government payors; physician adoption and recommendations of procedures utilizing our products; misuse or off label use of our products by physicians 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, 2016 and its Form 10-Q for the three months ended September 30, 2017. 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.
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