27 Jun 2016 --- A recently approved obesity device, AspireAssist, claims to reduce mealtime calorie consumption by 30% by inserting a surgically placed tube to drain a portion of stomach contents.
AspireAssist has been approved by the US Food and Drug Administration and is the latest in high-tech products claiming to tackle the obesity crisis.
The device, that allows the user to remove un-digested food from their stomachs before bodily consumption, should not be used with patients who have a history of eating disorders, or whom are only mildly overweight.
Food is removed from patients’ stomachs via a tube inserted into their stomach through a small incision in the abdomen. This is connected to a valve outside the body, that when attached to an external tube, allows the user to drain 30% of the food in their stomach before the calories are absorbed by the body.
“The AspireAssist device helps provide effective control of calorie absorption, which is a key principle of weight management therapy,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “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.”
Clinical trials showed that patients who used AspireAssit for one year combined with appropriate lifestyle counselling, lost 12.1% of body weight, whereas patients receiving only the lifestyle counselling lost 3.6% of their body weight. Results also suggested that there had been small improvements in conditions often associated with obesity, such as diabetes, hypertension and quality of life.
Due to the complex nature of the product, patients using AspireAssit require frequent monitoring by health care providers. As patients loose weight, tubing needs to be adjusted and monitored, and on-going counselling is vital to the overall success of the method.
The device has many safety features to ensure the users’ wellbeing. It keeps track of the number of times the drain tube is connected to the port and automatically stops working after 115 cycles (approximately five to six weeks of therapy), ensuring that patients aren’t over using the drain function.
The product is now available to US and non US patients who are over 22 years of age, have a BMI between 35 and 55 and have been unable to loose and keep weight off through traditional methods.