The U.S. Food and Drug Administration (FDA) announced the approval of a new minimally invasive obesity treatment device on Tuesday. This surgically-placed tube allows draining of a portion of the stomach contents following each meal the FDA said.
The AspireAssist device is only to be used for a short period of time by those moderately overweight and only by those without eating disorders. Patients who are 22 years of age or older who suffer from obesity with a body mass index (BMI) of 35-55 and have failed to achieve or maintain weight loss by other weight loss techniques will soon be eligible for this new treatment.
“The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “Patients need to be regularly monitored by their health care provider and should follow a lifestyle program to help them develop healthier eating habits and reduce their calorie intake.”
The tube placement is done by a surgeon who inserts a tube into the stomach with an endoscope through a small incision in the stomach area. The disk-shaped port valve sits outside of the body to be drained 20-30 minutes after each meal. The tube draining process takes 5-10 minutes and will remove 30 percent of consumed calories.
Clinical trials were conducted by the FDA of 111 patients. Those patients were treated with both AspireAssist and lifestyle therapy along with 60 others who only received lifestyle therapy. Those using AspireAssist lost around 12% of their body weight in comparison to less than 4% loss for those who only received lifestyle therapy.
Both groups showed small improvements in obesity-related conditions such as diabetes and hypertension the FDA said. The drain is to remain flush with the patient skin so frequent care while placed is required during weight loss. The drain is set to automatically stop after approximately 5-6 weeks of therapy, making it necessary for patients continuing to seek physician care. Some patients reported indigestion, nausea, vomiting, constipation and diarrhea during us. Other minor-to-serious surgical and other risks can be associated with the device.
This device should not be used in those with uncontrolled hypertension, diagnosed bulimia, diagnosed binge eating disorder, night eating syndrome, certain types of previous abdominal surgery, pregnancy or lactation, inflammatory bowel disease or stomach ulcers.
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