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 over 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 more than 75 countries. Over 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."
Request more information about Orbera®
Important Orbera® Intragastric Balloon System Safety Information:
- The Orbera® Intragastric Balloon is made to help you lose weight. From the time that your balloon is placed and for six months after it is removed, you need to follow a healthy diet and exercise program to lose weight. You may not lose weight if you do not follow the program. Your doctor’s clinical team, including dieticians, nutritionists and/or exercise trainers, should help you on your weight loss journey.
- The Orbera® Intragastric Balloon is for adults who are suffering from obesity and have not been able to lose weight and keep it off. To receive an ORBERA balloon, you must be willing to follow a 12-month program. The program begins with the use of the balloon and a healthy diet and exercise program for 6 months. That is followed by 6 more months of a healthy diet and exercise program without the balloon in your stomach.
- 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.
- You must maintain regular contact with your doctor while the balloon is in your stomach. Nausea and vomiting are common when the balloon is placed. Patients typically adjust to the balloon in the first few weeks, then these symptoms improve. If you adjust to the balloon, but then you begin to feel significant stomach pain, contact your doctor immediately as this may be signs of a significant problem with your stomach and could lead to death..
- Do not use Orbera® for more than 6 months. Prolonged balloon placement may increase the risk of the balloon deflating. A deflated balloon can cause the bowels to block, requiring surgery. While it has not yet been reported, it is possible for an unaddressed blockage to cause death.
- Call your doctor if you have any concerns about your health or well-being at any time during the 6 month placement of the balloon.
- For full safety information please visit Orbera.com/isi, 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.
** Apollo Care coaches are Texas-based Registered Dieticians.
*** Available at participating practices, terms and conditions apply.
- Orbera® US FDA Pivotal Study.