Tuesday, June 21, 2016

New obesity treatment device AspireAssist approved by FDA

Image courtesy:Aspire Bariatrics
One more gadget added to the armamentarium of obesity treatment device as FDA approves  The AspireAssist device[1]. This device uses a surgically placed tube in the stomach to drain about 30% of the content after every meal. AspireAssist, is created by Segway inventor Dean Kamen and a team of bariatricians and was patented in 2013[2].

It is not a short term procedure and is not indicated in patients who are moderately obese. Its main indication is in patients aged 22 and older, with BMI between 35-55 and who have failed to achieve and maintain weight through non-surgical procedure.

The short OPD procedure consists of endoscopically placing a tube in the stomach through a small incision in the abdomen. A small disc shaped port valve is connected to the tube and it lies outside the abdominal skin flushed with the body. The patient is taught to drain the content of the stomach 20-30 minutes after a meal into toilet. For optimal weight loss the patients should drain the contents atleast 3 times daily[3].

AspireAssist is in use in parts of Europe since late 2011. In a trial of 111 study participants who received AspireAssist and lifestyle modification vs 60 control participants who only received lifestyle modification, AspireAssist patients lost 3 times the body weight by simple lifestyle modification only.

All the patients are monitored closely as it requires shortening of the tube as patients lose weight and abdominal girth. Frequent electrolyte checkup and nutritional supplement are required, along with dietary and life style modification. The patient is also taught the hygiene of the abdominal port.

Side effects of the tube include diarrhea, indigestion, nausea and vomiting.

The risks associated with AspireAssist include risk of the surgical procedure and risk associated with the abdominal port. Surgical risk includes sore throat, pain, abdominal bloating, indigestion, bleeding, infection, nausea, vomiting, sedation-related breathing problems, inflammation of the lining of the abdomen, sores on the inside of the stomach, pneumonia, unintended puncture of the stomach or intestinal wall and death. 

A number of complications associated with the abdominal port requires removal of the tube and closing the port. Patient may present with abdominal discomfort or pain, irritation, hardening or inflammation of the skin around the site where the tube is placed, leakage, bleeding and/or infection around the site where the tube is placed and device migration into the stomach wall.

Contraindication to AspireAssist includes diagnosed bulimia, diagnosed binge eating disorder, night eating syndrome, certain types of previous abdominal surgery, pregnancy or lactation, inflammatory bowel disease or stomach ulcers. Certain systemic conditions like uncontrolled hypertension, serious pulmonary or cardiovascular disease, coagulation disorders, chronic abdominal pain also places the patients at high risk for abdominal surgery.



[1] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm506625.htm
[2] http://www.popsci.com/gadgets/article/2013-01/segway-inventor-patents-gadget-sucks-food-directly-out-stomach
[3] http://www.aspirebariatrics.com/about-the-aspireassist/

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