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.

This is rewarding gluttony! NO!

Awful!

1) I am very, very conscious of food waste and have been working hard to control my portions so I don't end up throwing food away because there are hungry kids out there and it makes me so sad. Also, chickens, cows, and pigs die to feed me - the least I can do is be respectful enough not to waste what's been killed for human consumption.

2) How is this teaching ANYONE good habits??? Sure, go ahead and fill your stomach to its max capacity, all you have to do is excuse yourself to the bathroom and bam, problem solved!

3) NO!

I am all for researching new, less invasive ways to manage over-eating but this is absolutely not the solution.

If like to see more trials and results from 2-3 years later. I wonder if you can use this multiple times with breaks inbetween? I won't be judgemental about something that can change someone's weight and their outlook on life. I'm also thinking this could be useful for someone who needed to lose weight in order to qualify for surgery... Say knee replacement for instance.

I've read this post and agree that I don't want to waste food, but how is this different than ordering food at a dinner with friends and only eating 1/4? After a 5 day trip with my husband, who was expected to eat his dinner and the leftover 3/4 of mine, I wonder what the right solution is.

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I've read this post and agree that I don't want to waste food, but how is this different than ordering food at a dinner with friends and only eating 1/4? After a 5 day trip with my husband, who was expected to eat his dinner and the leftover 3/4 of mine, I wonder what the right solution is.

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Bring home leftovers. Split a meal. Patronize restaurants that donate leftovers. Order a small plate or appetizer. Order a "add on" meat, many restaurants allow this--like add a shrimp skewer to your husband's meal at red Lobster. I've done all of these.

Heck even if you order a full entree and only eat 1/4 and waste the rest, it's different because you aren't doing it three times a day (or more) 7 times a week.

My first reaction when my mom told me about this today:

"You're joking"

My second reaction after she told me she wasn't joking:

"There are starving people in this world and we are THROWING more food away than we already do now..."

I don't know how this promotes a healthy lifestyle in any way shape or form. It is actually a monitored eating disorder.

I like to keep an open mind, but on this one I'm going to need some convincing.

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I've read this post and agree that I don't want to waste food, but how is this different than ordering food at a dinner with friends and only eating 1/4? After a 5 day trip with my husband, who was expected to eat his dinner and the leftover 3/4 of mine, I wonder what the right solution is.

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it's different because you aren't doing it three times a day (or more) 7 times a week.

The port limits you to 3 aspirations per day. After 30 Aspirations you need a new port and must return to your surgeon for follow up in order to get another. This limits abuse. You can't get around that. Not taking a side. Just want the right information out there.

I can't imagine ever wanting to do this.

Here is an FDA approved alternative to the two finger diet. Instead of throwing up your just empty it through a medical tube. I don't see how this is helping with the over problem of obesity... eating to much of the wrong foods. This pump removes the food before your body can start absorbing it, but if you are eating healthier how will this benefit you.

I will be astonished if this does not cause severe malnutrition problems and can you imagine the risk factors of getting an infection.

I'll pass.

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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.

I'm not sure I will ever be sold on this. I feel like bariatrics are really reaching to find new methods of weight loss, but how practical are they? Is this supposed to be temporary or permanent? Is therapy a requirement with this device?

I suppose only time will tell. Everything was doubted at one point.

I just read a pretty balanced point of view at http://conscienhealth.org/2016/06/obesity-drain-device-approved-by-fda/

"But here’s the thing. Once you get past the yuck factor, people who use this drain device are generally quite happy with it. Physicians and surgeons who were initially skeptical are surprised by how satisfied many of their patients are with their results.

Compared to other procedures and devices, it appears to be very safe and pretty easy to reverse. And people lose about 12% of their total body weight with it on average. That’s more than the average response to drugs and lifestyle therapy. It’s less than the typical response to a gastric sleeve or bypass surgery. The manufacturer claims that the costs will be significantly less than for bariatric surgeries. Finally, though, because it’s new, the long term outcomes are not yet fully known.

So you can expect to hear lots of jokes about this drain device, just as many people are still derisive about bariatric surgery. Be careful about dismissing it prematurely, though. It may turn out to be quite helpful for a significant segment of people living with obesity. Long-term data will tell us much more."

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I've read this post and agree that I don't want to waste food, but how is this different than ordering food at a dinner with friends and only eating 1/4? After a 5 day trip with my husband, who was expected to eat his dinner and the leftover 3/4 of mine, I wonder what the right solution is.

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it's different because you aren't doing it three times a day (or more) 7 times a week.

The port limits you to 3 aspirations per day. After 30 Aspirations you need a new port and must return to your surgeon for follow up in order to get another. This limits abuse. You can't get around that. Not taking a side. Just want the right information out there.

Okay so I amend my "or more" my point still stands.

I just read a pretty balanced point of view at http://conscienhealth.org/2016/06/obesity-drain-device-approved-by-fda/

"But here’s the thing. Once you get past the yuck factor, people who use this drain device are generally quite happy with it. Physicians and surgeons who were initially skeptical are surprised by how satisfied many of their patients are with their results.

Compared to other procedures and devices, it appears to be very safe and pretty easy to reverse. And people lose about 12% of their total body weight with it on average. That’s more than the average response to drugs and lifestyle therapy. It’s less than the typical response to a gastric sleeve or bypass surgery. The manufacturer claims that the costs will be significantly less than for bariatric surgeries. Finally, though, because it’s new, the long term outcomes are not yet fully known.

So you can expect to hear lots of jokes about this drain device, just as many people are still derisive about bariatric surgery. Be careful about dismissing it prematurely, though. It may turn out to be quite helpful for a significant segment of people living with obesity. Long-term data will tell us much more."

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Under the right care, with the right education and with an ethical doctor I could see this being beneficial. But some quack could open a clinic in LA and advertise this device to hungry women with a little pudge promising a thin, taut body while being able to eat as much cake and ice cream as they'd like. I guess you could argue the same thing for bariatric surgery, but there's just something that seems off about this type of procedure.

To me, it's the moral wrongness of consuming more food than you need to purge it later. Certainly, I'm guilty myself of eating more food than I need which is why I got fat in the first place. But I had the sense to feel terrible about it later just because I felt like I was feeding my hedonistic pleasure centers rather than nourishing my body (partially why I sought a restrictive procedure in the first place).

I still don't understand how this would effect long-term change as well. If I had to take my lap band out I'd do a revision at the same time because I know if I don't have my band I will go back to my old ways. This seems similar to the balloon in that sense (though the balloon doesn't cause food waste).

I'm not sold on it but I could see its applications being beneficial in certain cases. I just worry about abuse because even though there are safeguards in place, I'm sure someone out there could tamper with it and turn it into an efficient bulimia device, market it to people who shouldn't have it, and make a bunch of money.

I read about this several months ago, and as a nurse am horrified. Yes, we have lots of patients who have tubes into their stomachs for long periods of time without infection and such, so that part is fine But maintaining those tubes is a royal PITA. They hang on clothes and get pulled out, clog, and have no ends of problems. And that's just with liquids going IN. While I can see that this is slightly better than becoming bulimic because you don't have stomach acid in your throat and mouth, it just feels like medically induced bulimia without the erosion. Ugh.

Ummmmm no ???????????? your basically bulimic

Little tia

A direct port to my insides through which staph, bacteria, and more can enter my body. Sepsis, anyone?

I think not.

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It's not something I would choose personally, but I'm not going to denigrate anyone who chooses it. I am not them, I don't know their health, their lifestyle... I know nothing of them. If this can help some people lose the weight they need to lose to become healthier then that's fine by me.