This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: ORBERA™ Intragastric Balloon System
Applicant: Apollo Endosurgery, Inc.
Address: 1120 S Capital of Texas Hwy, Building 1, Ste. 300, Austin, TX 78746
Approval Date: August 5, 2015
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140008a.pdf
What is it?
The ORBERA Intragastric Balloon System is a weight-loss system that uses a gastric balloon that occupies space in the stomach. The balloon is placed into the stomach through the mouth, using a minimally invasive endoscopic procedure, while the patient is under mild sedation. Once in place, the balloon is filled with salt water (saline) so that it expands into a spherical shape. The balloon can be filled with different amounts of saline (from 400 to 700 cc) to best match the patient’s body structure.
How does it work?
The ORBERA Intragastric Balloon System takes up space in the stomach to help patients lose weight. The system is temporary and should be removed after 6 months.
When is it used?
The device is used in obese adult patients who have a Body Mass Index (BMI) of 30-40 kg/m2 who have been unable to lose weight through diet and exercise. It is intended to be used while a patient participates in a diet and exercise plan supervised by a health care provider.
What will it accomplish?
During the clinical study, the group of people who used the ORBERA Intragastric Balloon lost more weight than those who did not. The study included a total of 255 patients who were followed for one-year. During that period, 125 patients received the device and had it in place for six months. After the device was removed, they were followed for an additional six months. 130 patients participated in a 12-month behavior modification program and did not receive the device.
Patients with ORBERA lost an average of 21.8 pounds (10.2% of their body weight) after the device had been in place for six months. Three months after the device was removed (9 months after device placement), patients who received the device maintained an average of 19.4 pounds weight loss. The 130 patients who participated in the behavior modification program but did not receive the device lost an average of 7.0 pounds (3.3% of their body weight).
When should it not be used?
The device should not be used in patients who:
- already have an intragastric balloon
- have had prior gastrointestinal or bariatric surgery
- have any inflammatory disease of the gastrointestinal tract
- have potential upper gastrointestinal bleeding conditions
- have a large hiatal hernia
- have a structural abnormality in the esophagus or pharynx
- have serious esophageal motility disorders
- have a gastric mass
- have a severe clotting or bleeding disorder (coagulopathy)
- have liver failure (hepatic insufficiency) or cirrhosis
- are known to have or suspected to have an allergic reaction to materials contained in the ORBERA™ system
- have any other medical condition which would not permit elective endoscopy
- have a serious prior or present psychiatric illness
- have alcoholism or drug addiction
- who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant
- are unable or unwilling to participate in a medically supervised diet and behavior modification program with routine medical follow-up
- are receiving aspirin, anti-inflammatory agents, blood thinners (anticoagulants) or other gastric irritants
- are pregnant or breast-feeding
Additional information: Summary of Safety and Effectiveness and labeling is available online.