Devices

FDA Approves ‘Stomach Drain’ for Weight Loss

FDA has approved an Aspire Bariatrics PMA for the AspireAssist, a new obesity treatment device that uses a surgically-placed tube to drain stomach contents after every meal. “The AspireAssist device should not be used on patients with eating disorders, and it is not intended to be used for short durations in those who are moderately overweight,” an agency release says. It is intended for use in patients aged 22 and older who are obese, with a body mass index of 35 to 55, and who have failed other non-surgical weight-loss efforts. “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 agency says.

Surgeons insert a tube in the stomach with an endoscope via a small incision in the abdomen. A disk-shaped port valve that lies flush against the skin and is connected to the tube and remains in place. About 20 to 30 minutes after a meal, patients attach the device’s external connector and tubing to the port valve to drain the stomach’s contents. Once opened, it takes five to 10 minutes to drain food matter through the tube and into the toilet. “The device removes approximately 30% of the calories consumed,” FDA says.

Approval was 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% of their total body weight compared to 3.6% for the control patients,” the agency says. “Clinical trial results also suggested that both patient groups had small improvements in conditions often associated with obesity, such as diabetes, hypertension and quality of life. These improvements may be attributable to the lifestyle therapy, which includes nutrition and exercise counseling.”

Side effects include occasional indigestion, nausea, vomiting, constipation and diarrhea. “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,” FDA says. “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 the abdominal wall.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome