A new weight-loss device that will drain up to one-third of a person’s recently-eaten meal directly out of their stomach through a tube, was approved by the U.S. Food and Drug Administration (FDA) on June 14.
The obesity treatment device, called AspireAssist, uses a surgically-placed tube to drain stomach contents after every meal. The process takes about 5 to 10 minutes.
The device is designed by Aspire Bariatrics.
The FDA says the device should be used by obese individuals with a body mass index (BMI) of 35 to 55, and aged 22 and older who have not been able to lose weight by other non-surgical ways. The agency says the device should not be used by people with eating disorders or for short durations by those who are moderately overweight.
Less than 1 percent of the 25 million Americans with BMIs over 35, undergo bariatric surgery each year, said Dr. Christopher Thompson, associate professor of medicine at Harvard Medical School and the director of therapeutic endoscopy at Brigham and Women’s Hospital.
“There is clearly a need for a non-surgical weight loss procedure that is effective, safe, and reversible,” Thompson said, adding that the AspireAssist should be “a lower cost solution” to the healthcare system.
How it Works
First, surgeons make a small incision in the abdomen and insert a tube in the stomach with an endoscope. Afterwards, a disk-shaped port valve outside the body, flush against the skin of the abdomen, is connected to the tube and remains there.
About 20 or 30 minutes after eating a meal, the patient connects the device’s external connector and tubing to the port valve, opens the valve and drains the stomach contents. When the valve is opened the food travels through the tube into the toilet. A water pouch on the device loosens food particles in the stomach. About 30 percent of the calories consumed is drained out by the device.
“The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy,” said Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.
“Patients need to be regularly monitored by their healthcare provider and should follow a lifestyle program to help them develop healthier eating habits and reduce their calorie intake,” he added.
Clinical Trial
The FDA approved the device after a clinical trial of 111 patients treated with both the AspireAssist device and lifestyle therapy—which includes nutrition and exercise counseling. The trial included 60 control patients who received only the lifestyle therapy. After a year, results showed that those on AspireAssist lost about 12.1 percent of their total body weight, while the control patients lost 3.6 percent.
Those on AspireAssist and the control group both had minor improvements in conditions often related with obesity, such as diabetes, hypertension and quality of life, which may have been caused by the lifestyle therapy, the FDA said.
“We are very happy to be able now to offer this life-changing therapy in the U.S. to patients with obesity; many of whom felt, until now, that there were few viable solutions for them,” said Aspire Bariatrics CEO Katherine Crothall.
Side effects related to the device include occasional indigestion, nausea, vomiting, constipation and diarrhea. Patients may also be subject to risks related to the endoscopic surgical placement of the gastric tube as well as the abdominal opening for the port valve.
