Orbera® Managed Weight Loss System
Real-world experience. Real results.
Over 20 years of extensive global experience with thousands of positive outcomes.
Orbera® fills the gap between the non-surgical weight loss segment and the weight loss surgery segment, allowing you to do more for your patients who require more than drug therapy and dietary advice. The comprehensive, two-part program takes a holistic approach to weight loss, combining the use of an intragastric balloon with an individually tailored support program to tackle dietary, psychological, and exercise strategies to assist adult patients – with a BMI of 30 to 40 – in losing and maintaining weight.
- Patients can achieve 3.1x1 the weight loss with Orbera® than with diet & exercise alone
- US Pivotal Study demonstrated an average EWL of 38.4%* at 6 months
- #1 in global market share for intragastric balloons
- Established safety profile with nearly 300,000 placements globally
- A more than 20 year history of helping thousands of people lose weight
- Helps to fill the stomach and encourage portion control
- Straight-forward, non-surgical procedure
- Teaches healthy habits to help you keep the weight off even after the balloon is removed
Orbera® was commercially launched outside the U.S. in 2004, and is now used to assist patients with weight loss in over 80 countries. Nearly 300,000 Orbera® balloons have been distributed worldwide.
Clinical legacy of Orbera®
The Orbera® balloon was originally designed by a group of international physicians, who identified features of an ideal intragastric balloon effective in producing weight loss:
- Spherical shape with a smooth, soft surface to reduce chance of ulcers
- Filled with sterile saline rather than air to fill the stomach and reinforce portion control
- May be filled to a volume of 400-700cc
- Radiopaque valve to support visualization within the stomach
Since Orbera®’s inception, there have been over 250 peer-reviewed Orbera® publications around the globe including data on over 8,000 patients. Retrospective and pivotal studies show, time and again, that Orbera® is safe and effective, and helps patients lose the weight and also keep the weight off even after the device is removed.
Well tolerated for the majority of patients
Across the treatment period, Orbera® was well tolerated for the majority of patients. Common adverse effects include nausea, vomiting, and gastric pain and these typically resolve within one to two weeks after placement.
Clinicians report that patients come to regard their Orbera® in a very positive manner once transient side effects have subsided, judging it "good," "very good," or "excellent."
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Important Orbera® Intragastric Balloon System Safety Information:
- The Orbera® Intragastric Balloon System is a weight loss aid for adults suffering from obesity, with a body mass index (BMI) ≥30 and ≤40 kg/m2, who have tried other weight loss programs, such as following supervised diet, exercise, and behavior modification programs, but who were unable to lose weight and keep it off.
- To receive Orbera® you must be willing to also follow a 12-month program, beginning with the placement of Orbera® and continuing for 6 months after, that includes a healthy diet and exercise plan. If the diet and exercise program is not followed, you will not experience significant weight loss results; in fact, you may not experience any weight loss.
- Losing weight and keeping it off is not easy, so you will be supervised throughout this program by a team of physicians, physiologists, and nutritionists. This team will help you make and maintain major changes in your eating and exercise habits.
- Orbera® is placed for no more than six months. Any time that the balloon is in the stomach for longer than six months puts you at risk for complications, such as bowel obstruction, which can be fatal.
- Some patients are ineligible to receive Orbera®. Your doctor will ask you about your medical history and will also perform a physical examination to determine your eligibility for the device. Additionally, at the time of placement, the doctor may identify internal factors, such as stomach irritation or ulcers, which may prevent you from receiving Orbera®.
- You must not receive Orbera® if you are pregnant, a woman planning to become pregnant within six months’ time, or breast-feeding.
- Complications that may result from the use of Orbera® include the risks associated with any endoscopic procedure and those associated with the medications and methods used in this procedure, as well as your ability to tolerate a foreign object placed in your stomach. Possible complications include: partial or complete blockage of the bowel by the balloon, insufficient or no weight loss, adverse health consequences resulting from weight loss, stomach discomfort, continuing nausea and vomiting, abdominal or back pain, acid reflux, influence on digestion of food, blockage of food entering the stomach, bacterial growth in the fluid filling the balloon which can lead to infection, injury to the lining of the digestive tract, stomach or esophagus, and balloon deflation.
- Important: For full safety information please visit Orbera.com/dfu, talk with your doctor, or call Apollo Customer Support at 855-700-0780.
CAUTION: Rx only.
Reference information on file: MKT-01290-00R01
* Results are from individual customer testimonials and your results may vary.
- Orbera® US FDA Pivotal Study.