Adjustable Gastric Band Approved by FDA
The Food and Drug Administration (FDA) approved another implant for weight reduction surgery, the REALIZE Adjustable Gastric Band from Ethicon Endo-Surgery. Another indication for the device is use in patients who have obesity-related conditions, such as type 2 diabetes, which the company described in a release on their website.
The device is designed for use in morbidly obese patients who have a body mass index (BMI) of at least 40 kg/m2 or patients with BMI greater than 35 kg/m2 and one or more co-morbid condition. As well, patients should have failed more conservative treatment options for weight reduction.
The REALIZE band is a soft, adjustable band constructed from silicone. The device is wrapped around the stomach to create two different chambers of the stomach. The small, upper stomach includes a narrow opening which leads to the lower stomach. This limits the amount of food that can be contained within the new, upper stomach and, thus, patients intake of food.
The multi-center trial included over 275 patients who were followed over a three year period. Of that initial cohort, 228 patients completed the trial and three years of follow-up. On average, patients lost 42.8 percent of their additional body weight. 35 percent of the patients had weight loss over 50 percent of the excess weight. Just over ten percent of the patients lost three quarters of the excess body weight. Those findings suggest that the weight loss among these patients was sustainable over time, most likely maintained in concert with lifestyle and dietary modifications.
Among the adverse events experienced by patients in the trial, those most commonly reported included vomiting, nausea, GERD, and constipation. Less than four percent of the patients experienced serious adverse events related to the REALIZE band and were unanticipated.
October 2, 2007 Related topics: Product Approval & Certification, Bariatrics & Obesity