Ethicon Endo-Surgery, Inc., Files For FDA Approval Of New Gastric Band For Treatment Of Morbid Obesity
Ethicon Endo-Surgery, Inc., a Johnson & Johnson company, today announced that it has submitted a Premarket Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for its adjustable gastric band, an implantable device intended to treat morbid obesity.
The company’s submission includes results from a prospective multi-center clinical trial of 276 patients with a body mass index (BMI) of 40 or more (100 pounds or more above ideal body weight) or a BMI of 35 or more, with one or more obesity-related conditions such as Type 2 diabetes. The primary endpoint for the study was percent of excess weight loss at three years. Patients with these BMI are classified as morbidly obese.
The clinical trial was designed to evaluate the safety and effectiveness of the device, which has been commercially available outside the U.S. since 1996 and has been implanted in over 100,000 patients worldwide. The device is a soft, adjustable band that is fitted around the uppermost part of the stomach during laparoscopic surgery, creating a small pouch and restricting food consumption.
“The submission of this application to the FDA is an important milestone as we seek to provide the bariatric community more treatment options and solutions for morbid obesity, a life-threatening disease that continues to grow throughout the world,” said Kenneth Sumner, Ph.D., vice president, Worldwide Clinical and Regulatory Affairs, Ethicon Endo-Surgery, Inc. According to the American Society for Bariatric Surgery (ASBS), about 15 million people in the U.S. have morbid obesity, and in 2006, about 177,000 people had some type of bariatric surgery.
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