AspireAssist Obesity Device Approved by FDA

Troy Brown, RN

Disclosures

June 14, 2016

The US Food and Drug Administration (FDA) has approved the AspireAssist (Aspire Bariatrics) obesity-treatment device, which will allow patients to drain part of their stomach contents after each meal, preventing the absorption of approximately 30% of calories consumed.

The device consists of a tube that is endoscopically placed through an incision in the skin into the stomach and a disk-shaped port valve that is placed outside the body, flush with the abdominal skin. Approximately 20 to 30 minutes after eating, the patient attaches the device's external connector and tubing to the port valve, opens the valve and drains the contents into the toilet. The process takes approximately 5 to 10 minutes.

"The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight-management therapy," William Maisel, MD, deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health, said in an FDA news release. "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."

The device is intended for use in obese patients aged 22 years or older with a body mass index of 35 to 55 who have tried and failed to lose weight through nonsurgical weight-loss therapy. It should not be used for short-term durations in moderately overweight individuals or in patients with eating disorders.

The decision follows a review of data from a clinical trial of 111 patients treated with the device and lifestyle moderation and 60 control patients who received lifestyle therapy only. After 1 year, those who used the AspireAssist device lost an average of 12.1% of their total body weight, compared with 3.6% for those in the control group. Patients in both groups had small improvements in obesity-associated conditions including diabetes, hypertension, and quality of life. "These improvements may be attributable to the lifestyle therapy, which includes nutrition and exercise counseling," the FDA explained in the news release.

Patients must be monitored closely; the device automatically stops working after 115 cycles, or approximately 5 to 6 weeks of therapy, to ensure that the patient returns for medical follow-up and a replacement part for the device. The tube must be shortened as the patient's abdominal girth shrinks so that the disk remains flush with the skin. Patients also require ongoing counseling on lifestyle modification.

Side effects include occasional indigestion, nausea, vomiting, constipation, and diarrhea.

Risks

Risks associated with 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 abdominal lining, sores inside the stomach, pneumonia, unintended puncture of the stomach or intestinal wall, and death.

A number of risks related to the abdominal opening for the port valve may necessitate removal of the device. These include abdominal discomfort or pain, irritation, hardening or inflammation of the skin around the site of the tube placement, leakage, bleeding and/or infection around the site where the tube is placed, and migration of the device into the stomach wall. Persistent fistula (an abnormal passageway between the stomach and the abdominal wall) may occur after the device is removed.

Contraindications

Contraindications for the device include uncontrolled hypertension, diagnosed bulimia or binge eating disorder, night eating syndrome, certain types of previous abdominal surgery, pregnancy or lactation, inflammatory bowel disease, or stomach ulcers. The device is also contraindicated in those with a history of serious pulmonary or cardiovascular disease, coagulation disorders, chronic abdominal pain, or patients with a high risk for medical complications from an endoscopic procedure.

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