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CINCINNATI, OH – September 28, 2007 – Ethicon Endo-Surgery, Inc. announced today the U.S. Food and Drug Administration (FDA) approved for marketing the REALIZE™ 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.
Once the band is in place, surgeons attach the REALIZE Injection Port to the abdominal wall underneath the skin. Using the REALIZE Injection Port Applier, this can be completed in less than a minute, thereby decreasing time under anesthesia. The REALIZE Injection Port allows doctors to inject or remove saline to tighten or loosen the band. The tighter the band, the more quickly the upper stomach fills up and the less food a person can eat. Adjustments are made periodically based on the patient’s individual needs.