<em>ReShape</em><sup>®</sup> FDA Approval Featured on Med Device Online

ReShape® FDA Approval Featured on Med Device Online

FDA Approves Non-Surgical Balloon Device To Treat Obesity

The U.S. Food and Drug Administration (FDA) on Tuesday approved the first intergastric balloon device for obesity treatment available in the United States. The ReShape Integrated Dual Balloon System is minimally invasive, reversible, and appropriate for patients with a body mass index (BMI) between 30 and 40 kg/m2 who do not qualify for bariatric surgery. However, while early studies look promising, experts urge caution until there is data to support the effectiveness of the device long-term.

The device works by occupying space within the stomach, which makes the patient feel full without changing the stomach’s anatomy. Using an endoscopic procedure, a clinician inserts the balloons into the stomach and, once they are in place, inflates the balloons with a sterile saline solution. According to an FDA press release, the device may trigger other mechanisms that are not yet fully understood.

The FDA has approved the device for patients having a BMI range between 30 and 40 and suffering from one or more conditions related to their obesity, such as high blood pressure, high cholesterol, or diabetes. The FDA indicated that the device should be used alongside a strict diet and exercise regimen, and only when that regimen has failed on its own.

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