Ethicon Seeks OK of Gastric Obesity Band
U.S. firm Ethicon Endo-Surgery said it has filed for marketing approval of its adjustable gastric band to treat morbid obesity.
The Johnson & Johnson subsidiary said it has submitted to the Food and Drug Administration data from a trial involving 276 patients with a body mass index of 40 or more — or 100 pounds or more above their ideal body weight — or with a BMI of 35 or more plus one or more obesity-related conditions, such as type 2 diabetes.
The study measured percent of excess weight loss at three years.
Ethicon’s gastric band — approved outside the United States since 1996 — is fitted around the uppermost part of the stomach during laparoscopic surgery to create a small pouch and restrict food consumption.
The band has already been implanted in more than 100,000 patients worldwide, Ethicon said.
