Aspire Bariatrics wins FDA nod for weight-loss stomach tube

Aspire Bariatrics said yesterday it won FDA premarket approval for its AspireAssist device designed to treat obesity by draining a portion of the stomach’s contents after meals.

The system is placed through the insertion of a tube in the stomach via a small incision in the abdomen, with a disk-shaped port valve that lies outside the body flush against the abdomen connected to the tube. The company’s device is attached to the external connector and allows for the valve to be opened and the contents to be drained, removing approximately 30% of the calories consumed.

“The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy. 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,” FDA Center for Devices and Radiological Health deputy director Dr. William Maisel said in a press release.

The device is indicated to assist in weight loss in patients 22 and older with a body mass index of 35 to 55 who have failed to achieve and maintain weight loss through non-surgical wight-loss therapy, the company said.

The device was approved based on a 111-patient trial, Aspire Bariatrics said, in which after 1 year, AspireAssist patients reported an average weight loss of 12.1%, much higher than the 3.6% reported from the control group.

Data from the trial also indicated small improvements in conditions associated with obesity, including diabetes, hypertension and quality of life – though the improvements may be attributable to the lifestyle therapy treatments that are included alongside treatment with the device.

The company said the device requires frequent monitoring by a health care provider to monitor tube length as weight is lost and abdominal girth is reduced to maintain flush positioning of the port on the abdominal skin.

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