Gastric balloon for obesity treatment gains FDA nod

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The US FDA has approved the Reshape Integrated Dual Balloon System (ReShape). The system is a temporary weight-loss system of gastric balloons that are placed in a minimally invasive manner to occupy space in the stomach. They should be removed after six months.

The Reshape Dual Balloon system consists of two attached balloons that are filled and sealed separately. The balloons are placed into the stomach through the mouth using an endoscopic procedure while the patient is under mild sedation. Once in place, the balloons are filled with saline and methylene blue. When it is time to remove the balloons, they are first deflated then removed using another endoscopic procedure.

 

The device is for use 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 healthcare provider.

 

In the REDUCE pivotal clinical study, a prospective, randomised multicentre study to evaluate the safety and efficacy of the intragastric balloon system in obese patients as an adjunct to diet and exercise in the treatment of obese patients with one or more obesity-related comorbid conditions, 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 eight investigational sites in the USA. 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 counselling.

 

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).

 

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 oesophagus or pharynx; have serious oesophageal 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; 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 behaviour modification programme; and take prescribed proton pump inhibitor medication for the duration of the device implant.

 

 

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