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FDA Approves REALIZE(TM) Adjustable Gastric Band for Morbid Obesity
Date:9/28/2007

Ethicon Endo-Surgery, Inc. Provides New Option To Treat Morbid Obesity

CINCINNATI, Sept. 28 /PRNewswire/ -- Ethicon Endo-Surgery, Inc. announced today the U.S. Food and Drug Administration (FDA) approved for marketing the REALIZE(TM) Adjustable Gastric Band, a surgical implant for weight reduction and improvement in obesity-related health conditions, such as type-2 diabetes, in individuals suffering from morbid obesity.

The REALIZE Band is an innovative device intended for use in weight reduction for patients with morbid obesity and is indicated for individuals with a Body Mass Index (BMI) of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more co-morbid conditions. It is for use in morbidly obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs.

In the multi-center U.S. clinical trial of 276 patients with the REALIZE Band, patients who completed the three-year U.S. clinical trial (n=228) lost an average of 42.8 percent of their excess body weight. Thirty-five percent of patients who completed the three-year trial lost 50 percent or more of excess body weight and 10.5 percent lost 75 percent or more of excess body weight. The most commonly reported adverse events after surgery during the U.S. clinical trial were nausea, vomiting, constipation and gastroesophageal reflux (GERD). Only nine (3.3 percent) patients experienced a serious adverse event that was considered unanticipated and related to the REALIZE Band.

"This rigorous clinical trial showed patients using the REALIZE Band experienced significant weight loss within the first year, which remained steady over three years," said Ed Phillips, MD, FACS, principal investigator in the REALIZE Band clinical trial and Director of the Center for Minimally Invasive and Bariatric Surgery at Cedars-Sinai Medical Center in Los Angeles. "This procedure, combined with the proper suppo
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SOURCE Ethicon Endo-Surgery, Inc.
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