AUSTIN, Texas--(BUSINESS WIRE)--Apollo Endosurgery, Inc., a leader in minimally invasive endoscopic surgical products for bariatric and gastrointestinal procedures, is proud to announce the ORBERA™ Intragastric Balloon has met the American Society for Gastrointestinal Endoscopy’s (ASGE) Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) threshold standards for the treatment of obesity.
The review and analysis, written by members of the ASGE Bariatric Endoscopy Task Force and the ASGE Technology Committee, concluded that the ORBERA™ Intragastric Balloon met or exceeded the predetermined efficacy thresholds.
“ORBERA’s recognition by ASGE as the only endoscopic treatment that currently meets their predetermined efficacy threshold underscores the importance of ORBERA as a proven and effective non-surgical solution to help patients and their doctors fight obesity before their disease requires more invasive treatments,” said Todd Newton, Chief Executive Officer of Apollo Endosurgery. “We are committed to working with professional societies to help educate physicians about ORBERA as an option for obese adults with a BMI between 30-40.”
The ORBERA™ balloon is part of the ORBERA™ Managed Weight Loss System, a comprehensive, non-surgical two-part program that includes a balloon filling space in a patient’s stomach to reinforce proper portion control.
According to the ASGE, the organization conducts systematic review and meta-analysis to assess endoscopic bariatric therapies (EBT) using diagnostic and therapeutic thresholds established in 2012 as part of its PIVI initiative. The PIVI program was initiated to identify important clinical questions related to endoscopy and to establish reasoned diagnostic and/or therapeutic thresholds for endoscopic technologies designed to resolve these questions.
“Endoscopic bariatric therapies offer a viable, safe alternative for patients who have been unsuccessful at weight loss with diet and exercise. They may also be appropriate for patients who are not suitable for, or are unwilling to undergo, a more invasive surgical procedure,” said Christopher C. Thompson, MD, MHES, FASGE, chair of the ASGE Bariatric Endoscopy Task Force, in a recent press release from ASGE.
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 done under a mild sedative, 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 done under a mild sedative, 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 – which may include a dietician, psychologist and exercise physiologist – 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 220,000 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 revolutionizing the treatment of obesity and other gastrointestinal disorders by developing less invasive solutions for a whole new group of patients not seeking treatment today. Apollo is a global innovator pushing boundaries to bring new technologies and innovative products to markets in over 80 countries today. In particular, Apollo’s bariatric products fill the gap between non-surgical weight loss solutions and invasive surgeries, allowing physicians to do more for those patients who require more than drug therapy and dietary advice. For more information regarding Apollo Endosurgery, go to: www.apolloendo.com.
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