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Apollo Endosurgery, Inc. (“Apollo”), a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, today announced completion of enrollment in the ORBERA® Post Approval Study evaluating the ORBERA intragastric balloon.
The ORBERA Post Approval Study is a multi-center, open-label, prospective study of the safety and efficacy of the ORBERA system within the US. The study was a requirement of the US FDA’s approval of ORBERA in August of 2015. The study has enrolled 281 patients across 11 centers. The endpoints include the patient’s percentage of total body weight loss at 26 weeks and 12 months after balloon placement and the rate of adverse events at 26 weeks, the indwell time allowed for the balloon. This study includes 12 months of follow-up after balloon placement: six months with the balloon and an additional six months of follow-up after the balloon’s removal. Patient follow up and final study results are expected in early 2020.
“The ORBERA balloon is the most studied intragastric balloon globally with impressive weight loss and safety results based on its experience in Europe, Latin America and Asia Pacific regions. Reported US clinical results have shown an improvement in both the weight loss and safety data since the initial US pivotal study as US physicians gain experience with patient management. Outcomes consistently exceed criteria identified in guidelines published by our professional societies,” said Christopher Gostout, MD, Chief Medical Officer at Apollo Endosurgery.
Apollo has met all the milestones associated with the study and the FDA has assessed the current study status as “progress adequate”.
Obesity affects over 650 million people globally. An independent review by the American Society for Gastrointestinal Endoscopy identified ORBERA as the only endoscopic treatment that met their threshold standards for the treatment of obesity.1 More than 295,000 ORBERA balloons have been distributed worldwide in over 70 countries and the medical community has been using intragastric balloons from the makers of ORBERA for over twenty years.
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 Further Information
More on the laparoscopic device market in the U.S. can be found in a series of reports published by iData Research entitled the U.S Market Report Suite for Laparoscopic Devices. The full report suite includes market research data on laparoscopes, access devices, hand instruments, insufflation devices, suction-irrigation devices, direct energy devices, ultrasonic energy devices, hand-assisted devices, closure devices, gastric bands, powered morcellators, and female sterilization devices.
The iData report series on laparoscopic devices covers the U.S. and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxembourg), Scandinavia (Finland, Denmark, Sweden, and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, market value, forecasts, as well as detailed competitive market shares, and analysis of major players’ success strategies in each market and segment. To find out more about laparoscopic device market data, register online or email us at [email protected] for a U.S Market Report Suite for Laparoscopic Devices brochure and synopsis.