FDA approves minimally invasive AspireAssist weight loss device

Issue: July 2016

The FDA has approved a minimally invasive alternative to weight loss surgery for individuals with moderate-to-severe obesity, which entails an endoscopically-placed percutaneous gastrostomy tube and an external device that removes a portion of the calories consumed after meals, according to press releases from the FDA and the manufacturer.

“The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy,” William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in the FDA press release. “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 AspireAssist system (Aspire Bariatrics) is indicated for adults with a BMI of 35 to 55 for whom nonsurgical weight loss therapies have failed, and entails a surgically-placed tube that drains a portion of the stomach’s contents after meals. It is intended to be used long-term, and in conjunction with diet and exercise counseling and medical monitoring.

In a 15-minute outpatient procedure, which is fully reversible and does not alter the internal anatomy, the tube is inserted into the stomach endoscopically via a small abdominal incision. Then a disk-shaped port valve is connected to the tube and remains outside the body flush against the abdomen. Patients can then attach the device to the port valve 20 to 30 minutes after meals, open the valve and then drain the contents into the toilet, which takes between 5 to 10 minutes and removes an estimated 30% of the calories consumed.

Frequent monitoring is required to shorten the tube and keep the disk flush against the skin as weight is lost. The device also includes a safety feature to ensure it stops working after 115 cycles, or about 5 to 6 weeks of therapy, after which a replacement part is required.

“With less than 1% of the 25 million Americans with BMIs over 35 availing themselves of bariatric surgery each year, there is clearly a need for a non-surgical weight loss procedure that is effective, safe, and reversible. AspireAssist therapy satisfies this need and additionally offers a lower cost solution to the healthcare system,” Christopher Thompson, MD, associate professor of medicine at Harvard Medical School and the director of therapeutic endoscopy at Brigham and Women’s Hospital, said in a press release.

The approval follows results from a clinical trial, which were presented by Thompson at Digestive Disease Week last month, showing that patients treated with the device and lifestyle therapy (n = 111) lost a mean 12.1% total body weight after 1 year vs. 3.6% of controls (n = 60) who received lifestyle therapy only, according to a press release.

According to the study abstract, mean percent excess weight loss in the treatment group was 31.5% ± 26.7% on a modified intent to treat basis (vs. 9.8% ± 15.5% in controls), and 37.2% ± 27.5% on per-protocol basis (vs. 13% ± 17.6% in controls). The difference in mean percent excess weight loss between groups was 21.7% (95% CI; 15.3-28.1) on a modified intent to treat basis and 24.2% (95% CI; 15.5-32.9) on a per protocol basis, which exceeded the predefined 10% threshold. Moreover, 58.6% (95% CI; 50.3-66.5) of the treatment group achieved more than 25% excess weight loss on a modified intent to treat basis, and 68.3% (95% CI; 58.8-76.7) on a per protocol basis.

Perioperative abdominal pain and discomfort and postoperative peristomal granulation tissue and peristomal irritation were the most common adverse events, and 3.6% of the treatment group experienced serious adverse events, according to the study abstract.

“There was no evidence to suggest compensation of aspirated calories by increasing food intake, nor evidence for development of abnormal eating behaviors in the [treatment] group,” the researchers wrote.

According to the FDA press release, side effects include occasional indigestion, nausea, vomiting, constipation and diarrhea, and there are additional risks associated with the endoscopic surgical placement of the gastric tube and the abdominal opening for the port valve, all of which may require removal of the device, and device removal may carry a risk for persistent fistula.

“Patients with AspireAssist therapy have the opportunity not only to lose a significant amount of weight in a safe and controlled manner, but also to develop a healthier lifestyle through more mindful eating habits,” Louis Aronne, MD, FACP, the Sanford I. Weill Professor of Metabolic Research at Weill-Cornell Medicine, said in a press release.

Reference:

Thompson CC, et al. Abstract #381. Presented at: Digestive Disease Week; May 21-24, 2016; San Diego.

Disclosures: Aronne reports ownership interests and board membership in Jamieson Labs, consulting for Pfizer and Novo Nordisk, consulting and grant/research support from Eisai, consulting for GI Dynamics, JOVIA Health and Gelesis, ownership interests in Zafgen and Myos Corp, and consulting and grant/research support from Aspire Bariatrics. Thompson reports consulting for Boston Scientific and Covidien, consulting, grant/research support and other financial benefits from USGI Medical, Olympus, Apollo Endosurgery, ownership interests in GI Windows, and grant/research support and other financial benefits from Aspire Bariatrics.