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: ReShape Integrated Dual Balloon System
PMA Applicant: ReShape Medical, Inc.
Address: 100 Calle Iglesia, San Clemente, CA 92672
Approval Date: July 28, 2015
Approval Letter: Not yet available.
What is it? The ReShape Integrated Dual Balloon System (Reshape Dual Balloon) is a weight-loss system of gastric balloons that occupy space in the stomach. The system consists of two attached balloons that are filled and sealed separately. The balloons are placed into the stomach through the mouth using a minimally invasive endoscopic procedure while the patient is under mild sedation. Once in place, the balloons are filled with about 2 cups of salt water (saline) and a blue dye (methylene blue). If a balloon breaks, blue dye will appear in the patient’s urine. When it is time to remove the balloons, they are first deflated then removed using another endoscopic procedure.
How does it work? The ReShape Dual Balloon 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 adult obese patients who have a Body Mass Index (BMI) of 30-40 kg/m2 who have been unable to lose weight through diet and exercise. Patients must also have one or more obesity-related conditions such as diabetes, high blood pressure, or high cholesterol. Reshape Dual Balloon 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 this device lost more weight than those who did not use it. The study included a total of 326 patients at 8 investigational sites in the United States. Of the 326 patients, 187 received the device and 139 underwent the endoscopic procedure but did not receive the device. All study participants received diet and exercise counseling.
Patients with the device lost an average of 14.3 pounds (25.1% of their excess weight and 6.8% of their total body weight). The patients who did not receive the device lost an average of 7.2 pounds (11.3% of their excess weight and 3.3% of their total body weight).
When should it not be used? The device should not be used in patients who
- have had previous gastrointestinal or bariatric surgery
- have gastrointestinal inflammatory disease
- have potential upper gastrointestinal bleeding conditions
- have a gastric mass
- have a large hiatal hernia
- have structural abnormality in the esophagus or pharynx
- have serious esophageal motility disorders
- have severe coagulopathy
- have hepatic insufficiency or cirrhosis
- have serious alcoholism or drug addition
- have serious or uncontrolled psychiatric illness or disorders
- are pregnant or are breastfeeding or plan to become pregnant
- have ever developed too much serotonin (serotonin syndrome) and are currently taking any drug known to affect serotonin levels
- take use aspirin, anti-inflammatory agents, anticoagulants, or other gastric irritants daily
- are known or suspected to have an allergic reaction to materials in the device
- are unwilling or unable to participate in a medically-supervised diet and behavior modification program
- take prescribed proton pump inhibitor medication for the duration of the device implant
Additional information: Summary of Safety and Effectiveness and labeling will be available online.