June 14, 2016
The AspireAssist is a new, FDA-approved weight loss solution for people with obesity. Unlike many other weight loss procedures, it’s non-surgical and reversible.
The U.S. Food and Drug Administration approved a new obesity treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal.
The AspireAssist device should not be used on patients with eating disorders, and it is not intended to be used for short durations in those who are moderately overweight.
It is intended to assist in weight loss in patients aged 22 and older who are obese, with a body mass index of 35 to 55, and who have failed to achieve and maintain weight loss through non-surgical weight-loss therapy.
Watch the video provided by www.Aspirebariatrics.com
How it Works?
The AspireAssist works by reducing the calories absorbed by the body, while helping you make gradual, healthy changes to your lifestyle. After eating, food travels to the stomach immediately, where it is temporarily stored and the digestion process begins. Over the first hour after a meal, the stomach begins breaking down the food, and then passes the food on to the intestines, where calories are absorbed. The AspireAssist allows patients to remove about 30% of the food from the stomach before the calories are absorbed into the body, causing weight loss.
What is the procedure?
The AspireAssist tube is placed during a 15-minute outpatient procedure. Patients can usually return home within one to two hours, and many return to work very quickly compared to invasive bariatric surgeries. The does not usually require general anesthesia, and instead is typically performed under “twilight anesthesia” (also called conscious sedation or Monitored Anesthesia Care), which is used during many dental procedures.
The FDA reviewed results from a clinical trial of 111 patients treated with AspireAssist and appropriate lifestyle therapy, and 60 control patients who received only the lifestyle therapy. After one year, patients using AspireAssist lost an average of 12.1 percent of their total body weight compared to 3.6 percent for the control patients.
Clinical trial results also suggested that both patient groups had small improvements in conditions often associated with obesity, such as diabetes, hypertension and quality of life. These improvements may be attributable to the lifestyle therapy, which includes nutrition and exercise counseling.
Some important things(risks) you should note about AspireAssist:
- Patients require frequent monitoring by a health care provider to shorten the tube as they lose weight and abdominal girth, so that the disk remains flush against their skin.
- Frequent medical visits are also necessary to monitor device use and weight loss and to provide counseling on lifestyle therapies.
- The device also has a safety feature that 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); patients must return for a medical visit to get a replacement part for the device in order to continue the therapy.
- This safety feature helps ensure patients use the device properly during therapy.
- Side effects related to use of the AspireAssist include occasional indigestion, nausea, vomiting, constipation and diarrhea.
- The endoscopic surgical placement of the gastric tube is associated with risks, including 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.
- Risks related to the abdominal opening for the port valve include 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.
- All have the potential to necessitate removal of the device. After device removal, there may be a risk of persistent fistula, an abnormal passageway between the stomach and the abdominal wall.
- Contraindication :AspireAssist is contraindicated in those with certain conditions, including uncontrolled hypertension, diagnosed bulimia, diagnosed binge eating disorder, night eating syndrome, certain types of previous abdominal surgery, pregnancy or lactation, inflammatory bowel disease or stomach ulcers.
AspireAssist is also contraindicated in patients with a history of serious pulmonary or cardiovascular disease, coagulation disorders, chronic abdominal pain or those at a high risk of medical complications from an endoscopic procedure.
The AspireAssist System is manufactured by Aspire Bariatrics located in King of Prussia, Pennsylvania.
- FDA News