Medical Devices

FDA Approved Obesity Treatment Devices

Currently, there are four types of FDA-approved devices designed to treat obesity: Gastric Bands, Electrical Stimulation Systems, Gastric Balloon Systems, and Gastric Emptying Systems.

Gastric Bands

Lap-Band Gastric Banding System

The Lap-Band System is a surgically implanted device that helps adults who are at least 18 years old eat less and lose weight. The Lap-Band consists of a silicone band, tubing, and an access port. The inner surface of the silicone band is inflatable and is connected by the tubing to the access port. The band limits the amount of food that can be eaten at one time and increases the time it takes for food to be digested, helping people to eat less.

The FDA approved the Lap-Band System for use in obese patients with a Body Mass Index (BMI) of at least 40. It is also approved for patients with a BMI of 30-40 with one or more obesity-related medical conditions, such as high blood pressure, heart disease, diabetes or sleep apnea. This device is indicated for use only in adult patients who have failed non-surgical weight-loss alternatives, such as supervised diet, exercise and behavior modification programs.

Lap-Band Gastric Banding System showing the device on the stomach and a diagram of the device showing the gastric band, access port, and connection tubing.
Lap-Band System

Realize Gastric Band - Approved in 2007

The Realize Band is a surgically implanted device used to help adults (18 years of age or older) lose weight. The Realize Band consists of a silicone band, tubing, and an injection port. The band helps a person eat less by limiting the amount of food that can be eaten at one time and increasing the time it takes for food to be digested.

Realize Gastric Band diagram showing the band, balloon, tubing, injection port, and septum.

Realize Gastric Band

The FDA approved the Realize Band for patients who are morbidly obese, with a BMI of at least 40. It is also approved for patients with a BMI of at least 35 with one or more obesity-related medical conditions. The Band is indicated for use only in adult patients who have failed non-surgical weight-loss alternatives, such as supervised diet, exercise and behavior modification programs.

Electrical Stimulation Systems

Maestro Rechargeable System - Approved in 2015

The Maestro Rechargeable System is an electrical stimulator that is surgically implanted into the abdomen to block nerve activity between the brain and the stomach.  It consists of a rechargeable electrical pulse generator, wire leads and electrodes and is used to help people who are at least 18 years old lose weight. 

The Maestro System works by sending intermittent electrical pulses to the vagus nerve, which is involved in regulating stomach emptying and signaling to the brain that the stomach feels empty or full. External controllers allow the patient to charge the device and allow health care professionals to adjust the device’s settings in order to provide optimal therapy with minimal side effects. Although it is known that the electric stimulation blocks nerve activity between the brain and the stomach, the specific mechanisms for weight loss due to use of the device are unknown.

The FDA approved the Maestro Rechargeable System for use in obese patients who have failed at least one supervised weight management program within the past five years and who have either: a Body Mass Index (BMI) of 40 to 45, or a BMI of 35 to 39.9 and one or more obesity-related conditions, such as diabetes, high blood pressure, and sleep apnea.

Picture of the neuroregulator, with leads connected by suture wires to the anterior vagus nerve trunk and the posterior vagus nerve trunk.

Maestro Rechargeable System

Gastric Balloon Systems

ReShape Integrated Dual Balloon System (Reshape Dual Balloon) - Approved in 2015

Image of the device.

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.

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.

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.

ORBERA Intragastric Balloon System - Approved in 2015

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.

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.

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.

Diagram showing placement of the gastric balloon inside the stomach.
ORBERA Intragastric Balloon System

Gastric Emptying System

AspireAssist - Approved in 2016

The AspireAssist helps obese patients lose weight by draining a portion of the stomach contents after meals. The device consists of a tube that connects the inside of the stomach to a port (Skin-Port) outside of the abdomen. About 20-30 minutes after eating, the patient attaches the external components including the Companion, connector, tubing, and a water-filled reservoir, and drains the stomach’s contents. The patient then flushes the stomach with water by squeezing the reservoir and draining the stomach again. This system removes approximately 30 percent of consumed calories.

The FDA approved the AspireAssist for a specific patient population—obese adults with a Body Mass Index (BMI) of 35.0-55.0 kg/m2 who have failed to achieve and maintain weight loss with non-surgical weight loss therapy. The device is intended for long-term use in conjunction with continuous medical monitoring and lifestyle therapy to help patients develop healthier eating habits and reduce caloric intake.

It is important that doctors assess potential AspireAssist patients for eating disorders prior to A‐Tube placement. Bulimia, Binge Eating Disorder, and Night Eating Syndrome are contraindications for therapy. Patients should also continue to be monitored for development of eating disorders for the duration of treatment.

Image of the AspireAssist, detailing A-Tube, Skin-Port, Lanyard, Connector, Tubing Set, Companion, and Reservoir.

AspireAssist

Page Last Updated: 07/28/2016
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