Wednesday, August 31, 2016

New weight-loss device that drains food from the stomach via a tube is approved by the FDA

A bizarre new weight-loss device that drains food from the stomach via a tube surgically inserted through the abdomen wall, has been approved in the US.
A new weight loss device, AspireAssist, has been approved by the FDA to help treat obesity
Around 30 minutes after eating, the Aspire Assist device allows an obese patient to pour 30 per cent of the contents of their stomach out via the tube and into the toilet.
The device drains food from a person's stomach via a tube that is inserted through the stomach wall. It is connected to a port valve that rests flush against the skin of the patient's stomach
The stomach contents are removed before the food is absorbed, thus helping to prevent weight gain.
The device is made up of a disk-shaped port valve that sits outside the body, flush against the skin of the stomach. 
Internally, surgeons connect a tube from the patient's stomach, attaching it to the port valveThe device is made up of a disk-shaped port valve that sits outside the body, flush against the skin of the stomach
Internally, surgeons connect a tube from the patient's stomach, attaching it to the port valve.
After eating, the patient attaches an external connector and tube to the port valve.
The valve is then opened and the stomach contents drained via the tube into the toilet.
Once opened, the device takes five to 10 minutes to drain food from the patient. 
It's the latest option for millions of obese Americans who have been unable to lose weight via more traditional methods. 
Obesity is considered one of the nation's leading public health problems because it can trigger diabetes and lead to heart disease and other serious health problems.
About 38 per cent of all US adults are obese. A 5f 9ins person would be obese at 203 pounds.
Last week the Centers for Disease Control and Prevention reported that rates of obesity among women had reached 40 per cent for the first time. 

That compares to a 35 per cent obesity rate for men.
Dr William Maisel, of the US Food and Drugs Administration, said: 'The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy.
'Patients need to be regularly monitored by their healthcare provider and should follow a lifestyle program to help them develop healthier eating habits and reduce their calorie intake.'  
The FDA dictates the device should not be used for patients battling eating disorders, and it is not intended to be used for short periods of time in those who are moderately overweight.
It is designed to assist patients aged 22 or older who are obese, with a body mass index of 35 to 55.

Furthermore, it is to be used in those patients who have failed to achieve and maintain weight loss through non-surgical weight-loss therapy, the FDA said.
The FDA reviewed results from a clinical trial of 111 patients treated with AspireAssist and appropriate lifestyle therapy.
They were compared against a control group of 60 patients who received only the lifestyle therapy.
After one year, patients using AspireAssist lost an average of 12.1 per cent of their total body weight compared to 3.6 per cent 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 (high blood pressure) and quality of life. 
These improvements may be attributable to the lifestyle therapy, which includes nutrition and exercise counseling. 
The FDA reviewed results from a clinical trial of 111 patients treated with AspireAssist and appropriate lifestyle therapy.
They were compared against a control group of 60 patients who received only the lifestyle therapy.
After one year, patients using AspireAssist lost an average of 12.1 per cent of their total body weight compared to 3.6 per cent 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 (high blood pressure) and quality of life. 
These improvements may be attributable to the lifestyle therapy, which includes nutrition and exercise counseling.
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. After eating, the patient attaches an external connector and tube to the port valve. The valve is then opened and the stomach contents drained via the tube into the toilet
After that patients are required to 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 seen with AspireAssist included nausea, vomiting, constipation and diarrhea.