EXIT STRATEGY The AspireAssist drains about one-third of calories before they're absorbed.

A gastric tube implant that lets obese patients drain their stomachs into the toilet after a meal has just received the FDA's approval. The AspireAssist, manufactured by Aspire Bariatrics of King of Prussia, Pa., promises a reversible weight-loss solution that does not permanently alter internal anatomy.

Its endoscopically inserted tube and a port valve placed flush against the skin let patients empty a portion of his gastric contents into a toilet about a half-hour after eating, thus averting the absorption of 30% of consumed calories, says the company. Some have called it "machine-assisted abdominal vomiting."

When used in combination with nutrition counseling, routine exercise and frequent medical monitoring, the device offers a weight-loss solution when other non-surgical options have failed, says the company. In a clinical trial, 111 patients who received the AspireAssist and undertook lifestyle modifications lost an average 12.1% of their total body weight, while 60 patients who received lifestyle counseling lost only 3.6% of their weight.

Side effects of the device include "occasional indigestion, nausea, vomiting, constipation and diarrhea," says the FDA, and the outpatient tube placement and port valve use carry standard surgical risks. The device is intended for patients 22 years of age and older who have body mass indexes of 35 to 55. It "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," the agency notes.

Aspire Bariatrics says that at $7,000 to $10,000, the system's cost is comparable to that of gastric balloon methods.

David Bernard