|AspireAssist System--Courtesy of Aspire Bariatrics|
The FDA has added a fourth kind of obesity treatment device to its roster of approved interventions. The agency has approved the AspireAssist System from Pennsylvania-based startup Aspire Bariatrics. The device works to drain part of the stomach contents after each meal via a surgically place tube.
This stomach-emptying approach adds to the two gastric bands, two balloon-based, stomach-filling systems and one neurostimulator that are already approved by the FDA.
The new device is indicated for obese patients, with a BMI of 35 to 55, who are age 22 or older and have failed to achieve weight loss using nonsurgical means. It's intended to be used for long-term weight loss and maintenance--for a year or two or longer.
Patients use the AspireAssist to routinely dump almost one-third of their stomach contents after a meal directly into the toilet via a drain that it is implanted directly into the stomach. The idea is essentially the reverse of a traditionally placed feeding tube--only used outside the hospital for routine use after eating. For obvious reasons, the device is not to be used on patients with eating disorders.
"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, in a statement. "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."
In a 111-patient pivotal trial, after one year of use patients using AspireAssist and receiving lifestyle therapy lost an average of 12.1% of their total body weight, as compared with a control group receiving lifestyle therapy alone, who lost only 3.6%.
The device requires a surgeon to insert a tube in the stomach with an endoscope via a small incision in the abdomen. It connects to a disk-shaped port that lies on the skin of the abdomen. About 20 to 30 minutes after a meal, the patient attaches an external connector and tubing to the valve, which opens to drain the stomach contents. The process takes about 5 to 10 minutes.
It has an automatic shut-off feature that halts its functioning after 115 cycles of use; this requires the patient to make a physician visit to continue therapy and helps ensure that patients aren't misusing the device.
There are a series of potentially risks associated with the placement of the tube, as well as the maintenance of the port valve. These include infection, leakage, bleeding, and persistent fistula development.
Aspire Bariatrics' most recent financing was $12 million in venture debt from Hercules Technology Growth Capital that came early last year and was slated to get the company through a PMA application.
- here is the FDA announcement