FDA Approves the Aspire Assist Stomach pump, a Minimally-Invasive Alternative to Weight Loss Surgery for People with Moderate to Severe Obesity

[Alex Brecher 10,512]

Aspire Bariatrics, Inc., announced today that the US food & Drug Administration (FDA) has approved the AspireAssist® System, an endoscopic alternative to weight loss surgery for people with moderate to severe obesity. The AspireAssist procedure is indicated for adults with a BMI of 35 to 55 who have not succeeded with more conservative therapies.

"With less than 1% of the 25 million Americans with BMIs over 35, availing themselves of bariatric surgery each year, there is clearly a need for a non-surgical weight loss procedure that is effective, safe, and reversible. AspireAssist therapy satisfies this need and additionally offers a lower cost solution to the healthcare system," said Christopher Thompson, MD, Associate Professor of Medicine at Harvard Medical School and the Director of Therapeutic Endoscopy at Brigham and Women's Hospital.

The AspireAssist provides a novel approach to obesity treatment through Portion Control. It is intended for long-term duration of use and is to be used in conjunction with diet and exercise counseling and medical monitoring. The device is implanted in a 15-minute outpatient procedure, is fully reversible, and does not alter the patient's internal anatomy.

The AspireAssist was evaluated in the PATHWAY study, a 171-subject, multicenter trial in the US, and the results will be presented in San Diego in May at Digestive Disease Week, the largest annual international meeting of gastroenterologists and gastrointestinal surgeons. In a previous randomized US clinical study with the AspireAssist, patients lost an average of 46 pounds in the first year.

"Patients with AspireAssist therapy have the opportunity not only to lose a significant amount of weight in a safe and controlled manner, but also to develop a healthier lifestyle through more mindful eating habits," said Louis Aronne, MD, FACP, the Sanford I. Weill Professor of Metabolic Research at Weill-Cornell Medicine and a co-Principal Investigator of the PATHWAY study.

"We are very happy to be able now to offer this life-changing therapy in the US to patients with obesity; many of whom felt, until now, that there were few viable solutions for them," said Katherine Crothall, PhD, President & CEO of Aspire Bariatrics.

The food and Drug Administration approved a new and unusual weight loss device Tuesday: an external pump that dumps part of the stomach contents into the toilet.

Some critics have called it "assisted bulimia" but the device, approved for use in very obese patients, helps them lose on average more than 12 percent of body weight — far more than pills or most diets.

The device is considered minimally invasive and includes a tube that goes from the inside of the stomach to a port on the outside of the abdomen. The pump can be attached to the outside port as needed to remove about a third of the stomach's contents at a time.

Aspire Bariatrics of King of Prussia, Pennsylvania, which makes the device, has a video about it here.

Clinical trials showed patient lost an average of 46 pounds during the first year and another few pounds to make 50 pounds of weight loss by the second year.

"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," the FDA said in a statement.

"There is no such thing as medical bulimia or assisted bulimia," Sullivan told NBC News. Bulimia is an eating disorder defined by overeating and then purging, often through forced vomiting.

"Patients eat less with this therapy then they did before," she said. "People think patients can eat whatever they want and then aspirate it and that's just not true. It has to be liquid enough and the particles have to be small enough to get through the tube."

The device joins a growing list of new ways to help Americans lose weight, from carefully controlled diets to surgery and a batch of devices that make the stomach smaller in effect.

"THE ASPIREASSIST DEVICE SHOULD NOT BE USED ON PATIENTS WITH EATING DISORDERS."

Diet drugs don't work terribly well and doctors are reluctant to prescribe them. This new device is the first to remove food that people have already eaten before it can be digested.

The need is growing. The latest data from the Centers for Disease Control and Prevention shows that 38 percent of U.S. adults are obese, while 17 percent of teenagers fall under that category.

"The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy," said the FDA's Dr. William Maisel.

"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," he added.

The company has not said how much it will charge for the device, which is on the market in Europe. A surgeon will also have to implant the device in a short endoscopic procedure, and that cost may vary by center.

THIS NEW DEVICE IS THE FIRST TO REMOVE FOOD THAT PEOPLE HAVE ALREADY EATEN BEFORE IT CAN BE DIGESTED.

"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 FDA noted.

Side effects include indigestion, nausea, vomiting, Constipation, and diarrhea.

Obesity is calculated using body mass index (BMI) — a measure of height to weight — that's a score of 30.

People are considered overweight when their BMI hits 25.

Someone who is 5-foot-5 and weighs 149 pounds has a body mass index of 24, considered a healthy weight. Add a pound and the same person has a BMI of 25 and is considered overweight. At 180 pounds this person has a BMI of 30 and is considered obese.

BariatricPal has a BMI calculator online here.

[VSGAnn2014 12,992]

LMAO!

[wannaBthinsoon 1,634]

ok, so it looks to me like you wear a stomach pump around your neck with a straw through a port into your stomach. Um..just no. WHO THOUGHT THIS WAS A GOOD IDEA? YIKES!

[KristenLe 5,979]

Are they joking??? It's like a sump pump for your stomach! This is just wrong!

[WLSResources/ClothingExch 3,444]

Once I got to the description of the device, I had to stop reading. It would be so much simpler to take the unwanted portion of food and, rather than ingesting it so that a little gadget will spit it out, simply toss it into the trash or back into the refrigerator. This Aspire thingie has less charm that a penny gum ball machine.

On a slightly serious side, it sounds as though it isn't being considered [openly] for people who have had surgery: "The AspireAssist procedure is indicated for adults with a BMI of 35 to 55 who have not succeeded with more conservative therapies."

It may well sell like wildfire. I wonder what horror stories will come out a couple of years along.

Edited June 15, 2016 by WLSResources/ClothingExch

[Syl 153 35]

Once I got to the description of the device, I had to stop reading. It would be so much simpler to take the unwanted portion of food and, rather than ingesting it so that a little gadget will spit it out, simply toss it into the trash or back into the refrigerator. This Aspire thingie has less charm that a penny gum ball machine.

On a slightly serious side, it sounds as though it isn't being considered [openly] for people who have had surgery: "The AspireAssist procedure is indicated for adults with a BMI of 35 to 55 who have not succeeded with more conservative therapies."

It may well sell like wildfire. I wonder what horror stories will come out a couple of years along.

It sounds like a horror story

Sent from my SM-G930T1 using the BariatricPal App

[Catmom4 149]

I actually saw this on a documentary on tv about weight loss surgery. A man in England had it and after he would eat, he would go to the bathroom and pump out the contents into the toilet. He said he did it because he didn't want to give up being able to eat "normal" portions of food... It was kind of gross to watch...

[jess9395 5,449]

I find this morally repugnant as well. It's basically setting out to intentionally waste food when people are starving. It's creating an industry out of it.

First world problems indeed.

[cseidman 175]

I find this morally repugnant as well. It's basically setting out to intentionally waste food when people are starving. It's creating an industry out of it.

First world problems indeed.

I thought the same thing!

I also can't imagine how any emotionally healthy person would think this is a good idea. Sure, I'll eat that whole pint of ice cream, cuz I can just pump it right back out. I don't get it.

Sent from my iPhone using the BariatricPal App

[OzRoo 1,492]

OMG !!! Words escape me ...

[KristenLe 5,979]

I actually saw this on a documentary on tv about weight loss surgery. A man in England had it and after he would eat, he would go to the bathroom and pump out the contents into the toilet. He said he did it because he didn't want to give up being able to eat "normal" portions of food... It was kind of gross to watch...

Mechanical bulimia...how gross!!!

[borg/assimilated 576]

Well, the jury is still out on this one. It will be interesting to see how well it works and how well embraced by the bariatric professionals over the next few years. To me pumping gastric contents into the toilet after eating is somewhat repugnant, but it may well help some people on their way to weight loss.

[reree6898 1,164]

The whole concept of that truly is disturbing to me.

[ErinMarie 186]

I would really like to know your opinion on this @AlexBrecher.

[Alex Brecher 10,512]

I would really like to know your opinion on this @AlexBrecher.

I felt very angry and upset when first exposed to this technology a few years ago....I even wrote an article about how abhorrent the concept was.

Every time I get this angry, I start doubting my feelings. So I started researching the procedure and device and talked to a few patients that are using it. I got to know the procedure a little better, understood their expectations, needs, and results.

What I see are patients benefiting from this method with an outstanding safety profile...

Sometimes our mind tricks us with hate and anger.... I don't like this so I turn it into something more rational for me.

I recently heard a very moving presentation from one of the investigators and a patient. I personally don't know that I'd recommend it, but the truth is that now that it's approved doctors and patients will decide if this succeeds or fails.