Unusual Obesity Device Called AspireAssist Approved by FDA

obesity device AspireAssist

The Food and Drug Administration (FDA) has approved an obesity device called AspireAssist that will allow people with a body mass index of 35 to 55 to literally drain their meals from their stomach. This unusual approach to dealing with obesity is reserved for individuals who meet specific criteria and is not without side effects.

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How AspireAssist works
The AspireAssist will prevent individuals from absorbing approximately 30 percent of the calories they consume at a meal. To make this possible, approved candidates can expect the following to occur:

  • A surgeon will insert a tube in the stomach using an endoscope via a small incision made in the abdomen
  • A port valve is positioned outside the body, flush with the abdominal skin
  • Patients are given an external connector, tubing, and a reservoir and taught how to use them
  • About 20 to 30 minutes after eating, patients attach the connector and tubing, open the valve, and drain their stomach contents into a toilet, a process that takes 5 to 10 minutes
  • Once the stomach contents are drained, the patient flushes the stomach with water from the reservoir and drains the stomach again
  • As a patient’s stomach girth declines, it will be necessary to shorten the tube so the port remains flush with the skin

Pictures of how the AspireAssist looks and is positioned in and on the body can be seen here.

Trial results concerning AspireAssist
A total of 171 obese individuals participated in the clinical trial: 111 had the device and practiced lifestyle moderation (diet and exercise) and 60 controls received lifestyle therapy only. At the end of one year:

  • Weight loss among those who had AspireAssist averaged 12.1 percent of their total body weight compared with only 3.6 percent among those in the control group
  • Participants in both groups showed improvements in diabetes, quality of life, and high blood pressure. The improvements “may be attributable to the lifestyle therapy, which includes nutrition and exercise counseling,” according to the FDA.

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More about AspireAssist

  • Candidates must be 22 years or older and have failed to lose weight using nonsurgical weight loss methods
  • The device is not for short-term use among individuals who are moderately overweight or who have eating disorders
  • AspireAssist automatically stops working once the patient has used it 115 times, or about 5 to 6 weeks. This ensures that the patient will return to the doctor for a follow-up visit, ongoing lifestyle counseling, and a replacement part for the device
  • Complications and risks associated with placing the gastric tube in the stomach endoscopically include pain, abdominal bloating, bleeding, indigestion, infection, nausea, vomiting, inflamed abdominal lining, breathing problems associated with sedation (used before placing the tube), sores in the stomach, puncture of the stomach or intestinal wall, pneumonia, and death
  • Complications and risks that may make it necessary to remove the device include abdominal pain or discomfort, leakage, inflammation or hardening of the skin around the tube placement site, infection and/or bleeding at the tube placement site, and migration of the device into the wall of the stomach
  • Side effects associated with having the device include occasional indigestion, diarrhea, nausea, vomiting, and constipation
  • Individuals who have any of the following conditions are not candidates for AspireAssist: uncontrolled high blood pressure, bulimia or binge eating disorder, night eating syndrome, anemia, inflammatory bowel disease, stomach ulcers, history of certain abdominal surgeries, pregnancy or lactation, history of serious cardiovascular or pulmonary disease, chronic abdominal pain, or coagulation disorders. Anyone who is at high risk for medical complications associated with having an endoscopic procedure also is not eligible.

The AspireAssist device joins five other FDA-regulated medical devices specifically for treating obesity. They include Lap-Band Gastric Banding System, Realize Gastric Band, Maestro Rechargable System, ReShape Integrated Dual Balloon System, and ORBERA Intragastric Balloon System.

Sources
Food and Drug Administration. FDA approved AspireAssist obesity device
Food and Drug Administration. Obesity treatment devices
Food and Drug Administration. AspireAssist—P150024

Image courtesy of Pixabay

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