Pharmaceutical

FDA approves new weight loss device

bathroom scale iStock CROPPED FDA approves new weight loss deviceThe Food and Drug Administration (FDA) has approved a new weight loss device that allows patients to drain part of their stomach contents after each meal, preventing the body from absorbing about a third of consumed calories.

The AspireAssist, manufactured by Aspire Bariatrics, consists of a tube that is inserted into the stomach by a surgeon with an endoscope via a small incision in the abdomen. A disk-shaped port valve that lies outside the body, flush against the skin of the abdomen, is connected to the tube and remains in place.

About 20 to 30 minutes after meal consumption, the patient attaches the device’s external connector and tubing to the port valve, opens the valve and drains the contents. Once opened, it takes approximately five to 10 minutes to drain food matter through the tube and into the toilet.

Patients who choose AspireAssist require frequent monitoring by a health care provider to shorten the tube as they lose weight and abdominal girth, so that the disk remains flush against the skin. Frequent medical visits are also necessary to monitor device use and weight loss and to prove counseling on lifestyle therapies.

The device also has a safety feature that keeps track of the number of times the drain tube is connected to the port and automatically stops working after 115 cycles (approximately five to six weeks of therapy), after which patients must return to their doctor for a replacement part for the device in order to continue therapy.

AspireAssist is not recommended for people with eating disorders, nor is it recommended for short durations in those who are moderately overweight. It is designed to assist in weight loss patients ages 22 and older who are obese, with a body mass index of 35 to 55, who have failed to achieve and maintain weight loss through non-surgical weight-loss therapy.

“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 device was approved based on a clinical trial of 111 patients treated with AspireAssist and appropriate lifestyle therapy, and 60 control patients who received only the lifestyle therapy. After one year, patients using AspireAssist lost an average of 12.1 percent of their total body weight compared to 3.6 percent for the control patients.

AspireAssist side effects include occasional indigestion, nausea, vomiting, constipation and diarrhea.

Risks associated with the endoscopic surgical placement of the gastric tube include sore throat, pain, abdominal bloating, indigestion, bleeding, infection, nausea, vomiting, sedation-related breathing problems, inflammation of the lining of the abdomen, sores on the inside of the stomach, pneumonia, unintended puncture of the stomach or intestinal wall and death.

Risks related to the abdominal opening for the port valve include abdominal discomfort or pain, irritation, hardening or inflammation of the skin around the site where the tube is placed, leakage, bleeding and/or infection around the site where the tube is placed, and device migration into the stomach wall. All have the potential to necessitate removal of the device. After device removal, there may be a risk of persistent fistula, an abnormal passageway between the stomach and abdominal wall.

AspireAssist should not be used in patients with certain conditions including 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. Patients with a history of serious pulmonary or cardiovascular disease, coagulation disorders, chronic abdominal pain, or those at high risk of medical complications from an endoscopic procedure should not use AspireAssist.

Source: FDA