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.

Well...the positives- no major surgery, and tube removal is easy.

You cannot aspirate 100@% of food eaten , so you cannot overeat and still lose weight

Virtually painless

Not bulemia

Highly monitored while having the device.

Have to chew chew chew for the food to pass through.

You don't walk around with a pump around your neck- virtually unnoticeable button...

Just a few points

Lisa

My boyfriend eats less than I do. We share a meal or an app and he usually takes home half of his share. He likes to graze... There are lots of ways to minimize the waste.

Regarding this procedure, I am grateful people have choices, but I find this appalling and I am not sure I can get behind it. It's like some kind of distopia future world...

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 am an “Aspire Assist” user for the last 4 years. This method should be compared to Gastric Bypass or Gastric Sleeve. Those procedures aren´t for everyone. Neither is the Aspire Assist. We all have a problem eating so we gain weight. The difference between the methods is – as I see it :

• I have just a tube in my stomach. An ordinary procedure that is very simple. If I don’t want it or need it, I can have it taken out. Nothing is changed inside. The side effects mentioned above are very minor, compared to horrible ones with GP.
  
• I need to learn how to chew my food properly. And this will automatically make me eat less. I now can realize when I am full so I can stop eat in time. I definitely can NOT binge!
  
• Since the problem is in the head, I have time on my side to change my behavior with food, and learn how and what to eat. I am not forced to do anything if I don´t want to. The behavior change is by will.
  
• It is NOT AT ALL that I can eat a ton of food and then just express it. The chewing is crucial. If you don’t chew – you can´t use the device. And I promise you… after 45 minutes chewing your meal, you are tired of it! And my meals, when eating mindful, is more delicious nowadays.

The first period I use it to lose weight. When I reached my goal, I can use it to maintain my weight. And the body needs time to adjust.

Nobody is mentioning anything about waste to a person who eats a lot and then let it pass through the "normal" system. I just take it out a little before it passes. This is not more of a waste than the other in my eyes.

I see the Aspire Assist method as this:

• The method is not dangerous! (Makes me feel safe)
• I can eat what I enjoy! (Makes me happy)
• The reward system in the brain gets satisfied! (Makes me happy)
• I lose weight, and I keep it! (Makes me happy)

I am an “Aspire Assist” user for the last 4 years. This method should be compared to Gastric Bypass or Gastric Sleeve. Those procedures aren´t for everyone. Neither is the Aspire Assist. We all have a problem eating so we gain weight. The difference between the methods is – as I see it :

• I have just a tube in my stomach. An ordinary procedure that is very simple. If I don’t want it or need it, I can have it taken out. Nothing is changed inside. The side effects mentioned above are very minor, compared to horrible ones with GP.
• I need to learn how to chew my food properly. And this will automatically make me eat less. I now can realize when I am full so I can stop eat in time. I definitely can NOT binge!
• Since the problem is in the head, I have time on my side to change my behavior with food, and learn how and what to eat. I am not forced to do anything if I don´t want to. The behavior change is by will.
• It is NOT AT ALL that I can eat a ton of food and then just express it. The chewing is crucial. If you don’t chew – you can´t use the device. And I promise you… after 45 minutes chewing your meal, you are tired of it! And my meals, when eating mindful, is more delicious nowadays.

The first period I use it to lose weight. When I reached my goal, I can use it to maintain my weight. And the body needs time to adjust.

Nobody is mentioning anything about waste to a person who eats a lot and then let it pass through the "normal" system. I just take it out a little before it passes. This is not more of a waste than the other in my eyes.

I see the Aspire Assist method as this:

• The method is not dangerous! (Makes me feel safe)
• I can eat what I enjoy! (Makes me happy)
• The reward system in the brain gets satisfied! (Makes me happy)
• I lose weight, and I keep it! (Makes me happy)

It's really great hearing this from an actual Aspire Assist patient! Thank you very much for sharing this info with our community.

Can't believe they approved this! It's like medically assisted and condoned bulimia. There is the warning that people without eating disorders should not get it. As someone who's dealt with anorexia & bulimia, I say where there's a will, there's a way. If someone goes to a doctor that's not familiar with their history.........

I was thinking this is like having an Ostomy bag. Who wants that.. NO ONE EVER.

Hi, I am an Aspire Assist user. I have been using Aspire for 2 years. I decided to participate in the Aspire Assist study because I was able to lose weight on my own, but after a certain amount of weight, no matter what I did, I could not seem to lose more. I don't regret this decision, it was one of the best I have made in my life. That's why it's so disheartening to hear all the negative and hateful comments about the program.

This site is a site about people who had WLS or are considering it. Anyone who has WLS or is considering it, knows how hard it is to lose and keep weight off. I'm responding to the people who are curious about Aspire or considering Aspire. It is not assisted bulimia. If anything, it's early or controlled pooping. You are taking a 3rd of the food out of your body before digestion is complete. You will not absorb extra calories.

The reasons why I aspirate is calorie control. Sometimes I have a bad night and emotionally overeat. Sometimes I'm out with friends and overeat. By the time my brain registers that I'm full, I'm stuffed. Before my tube I would feel bad and sometimes compound the damage by eating more. Now with the tube, I get rid of some of the damage and do better the next day. I also work jobs where I can't move all the time and sometimes don't have access to healthy food choices. Again, I aspirate those calories. At the end of the day the A-tube is a tool. It doesn't work unless you use it. It is not a quick fix. I still can eat the foods I love.

What I love about the program is that it DOES teach you better food habits and choices. I have made a lifestyle change because of my A-tube. Watching what comes out of the tube has given me ideas of why, after eating certain foods, I still felt hungry. Certain foods I will never eat again because I can see what going on inside my body. When I started, still learning about the device, I would look at my food as it was coming out the tube. It was mostly watery and chunky. I still could name some veggies.

One day, I ate garlic bread and I noticed it was greasier than normal as I was watching it come out of the tube. It was disgusting because it stuck and clung to the tube. I could see actual fat and I could not help but think the rest of the fat that is in my body and what damage it is doing. Is it sticking to me the way it sticking to my tube? I threw out the other half of that garlic bread.

I was grateful the tube was a mirror that day. Sometimes we eat bad choices and don't realize it or realize it and rationalize it. After the tube I couldn't do that anymore.

Aspire Assist has taught me to learn how to modify some food choices and explore others. I discovered veggies that I never would had tried before and love them. When eating foods that have higher fat, I eat smaller amounts. I learned to know the difference between mental hunger and physical (mental is worse for me personally). I am more active and blessed be to at a job that does allow me to move more.

I am nearing the end of my journey with Aspire. I have lost the weight I wanted to lose with it, plus more. I am in maintenance, so I use the device less. That makes me feel empowered because again it is a tool not a quick fix. I like it when I exercise and make good choices. I don't need to aspirate but I am grateful to have the device near me for slip ups because we all have bad days. When I do get my tube removed, the lessons I have learned from it will not go away.

Also, my body will still be way it was beforehand, with no shortened stomach or intestines removed. I am truly grateful to be a part of the study. I realize that this may not be for everyone, what works for me may not work for you, but what works for you may not be for someone else. At the end we are all here because of the inability to lose weight with our own sheer will power. Don't knock down someone for using a method because you don't like it or understand it.

Hi, I'm from Sweden and Aspire is approved here and reimbursed since 2016 in Sweden. We started in 2012 with the first clinical trial and then a comparative trial GBP vs Aspire. The results are great and the method is safe. Up until now we have 165 patients using Aspire and no serious complications since 2012. Some have stopped the treatment and where happy they choose Aspire as it is completely reversible. Nothing is changed inside.

The results are am EWL of 65% after a year and continuing weight loss year 2.

Put Aspire in the right context as an alternative if you don't want or can't have one of the established surgical procedures. Before Aspire as a long term treatment, the only choice was to stay obese. Much worse if you ask me. All comments on Aspire as bulimic, a waste of food, the yuck factor and much more, is due to the fact that yo don't know about the method. We had those reactions at start in Sweden too. Today the talking is quite different most of the time. The method works, is safe and really helps people loose weight in a safe and stable way. It is controversy to bulimia as the chewing is so far from a bulimic eating. The diameter of the A-tube is 6mm. You translate that into inches. Nothing swallowed can be larger than that. It takes for ever to eat a meal so the portions are smaller. Where is the food waste now? When flushing the food smells like the food eaten 20 minutes earlier. So the yuck factor is more a question of what you where eating before. Don't see Aspire as a threat to surgical procedures, but a complement to those not wanting surgery. We have 4 years results coming up this summer in Sweden so we do have som long term results now. Still no complications....... Hope to be back to answer more comment on this forum soon.

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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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Not at all. My son has a gastrostomy feeding tube directly into his stomach. He's had it for nearly five years at this point, and has never had an infection. It's not much worse than a (large) piercing. He had some issues with granulation tissue early on, but that all resolved after six months or so when he finished healing. We occasionally have some issues with leakage around the port. Some people will get skin breakdown from it.

That said, I could see someone figuring out how to bypass the restrictions on the aspire assist port fairly easily. It doesn't seem like a good idea to me.

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If you bypass the usage with Aspire, you gain weight. With weight gaining, the tube will become too short, and you have 2 choices. Either you jump on to the train again, using the Aspire as it should be used. Or, you will be told by ur nurse it doctor that the tube have to come out. An extra control that the patient uses the device in the right way.

I just read an article about the new AspireAssist device by Dr. Yoni Friedhoff. He's a medical professional I trust and look up to:

The Aspire Assist: Surgical Bulimia Or A Case Study In Weight Bias?

I can't tell you how many people have contacted me about the Aspire Assist. What's been genuinely shocking to me is that the sentiment surrounding the online commentary, as well as the emails I'm receiving, is hugely reflective of weight bias - including from colleagues who I know are champions in the fight against weight related stigma. I wrote this post when the Aspire Assist was first launched, and I'm updating and reposting it in the hopes of triggering at least a little bit of reflection.

Is this new device simply a condemnable medical bulimia machine?

That's certainly the tenor of the discussion out there as generally the reports on this are either pretty angry or simply express revulsion.

Superficially it really does sound horrifying, and undeniably, at first blush it's not what I would consider to be the intervention I'd always hoped for. But when researching the story of course I needed to know - what type of studies have been done on it to date?

Believe it or not, their very early data's interesting. Now this isn't peer reviewed published data, just a presentation, but in it they describe the 111 patients who were randomized to receive an Aspire Assist. 74% of them completed the year long study (vs. only 50% of the control group who received the same lifestyle counselling as the Aspire Assist group but no Aspire Assist).

The results were dramatic. This 15 minute long outpatient endoscopic procedure led completers to lose nearly 40lbs on average representing a loss of 15% of their presenting weights. The completers of the control group meanwhile lost on average just 4lbs.

Not surprisingly, there were post-operative adverse effects - the most common being irritation or granulation of the stoma (the exit port). There were only 4 subjects who reported "serious" adverse effects and all were quickly resolved.

Eating behaviours were also monitored. Pre-surgically subjects were screened for binge-eating, bulimia, and night eating syndrome. None of the Aspire Assist patients were reported to experience worsened eating behaviours, while one control subject developed bulimia.

Interestingly, self-reported data actually demonstrated improvements in Aspire Assist subjects' eating behaviours with more thorough chewing, more Water consumption greater meal planning, more mindful eating, and decreased calorie consumption (confirmed by the fact that losses were greater than would be predicted by simple aspiration).

And as far as tolerability goes, the vast majority reported satisfaction with the device, with 93% of survey respondents reporting that they would be somewhat or very likely to recommend it to others.

Comparing the Aspire Assist to the other endoscopic bariatric procedure, the intra-gastric balloon (a procedure that has not been raked over society's coals) the Aspire Assist appears to lead to markedly larger losses with greater response rates and fewer serious adverse effects.

So yes, back to the shock, horror and repulsion, while I readily agree that on its surface both the premise and procedure is less than appetizing, I'm pretty sure that safety and efficacy, not grossness, are what determine the utility of an intervention. If larger, longer, studies reproduce these results whereby the Aspire Assist doesn't lead to or exacerbate disordered eating, involves minimal risk, has minimal adverse metabolic or nutritional consequences, and leads to sustained losses which in turn had demonstrable medical or quality of life benefits, why wouldn't I consider it?

As I've written before it'd be wonderful if everyone lived incredibly healthful lifestyles and in turn those incredibly healthful lifestyles guaranteed weight loss (they don't BTW), but I think my job as a physician is to ensure people are equipped to make informed decisions, not to make decisions for them, or to judge the ones that they make. If the Aspire Assist proves to be both safe and efficacious in the long run, I'll happily discuss its pros and cons with each and every suitable patient. I'll also happily discuss more traditional bariatric surgery, pharmacotherapy, purely behavioural therapy and also the option of doing absolutely nothing with them. And I'll do it all in a nonjudgmental manner too - because my job is to ensure my patients are aware of the risks and benefits of all of their treatment options, including watchful waiting, and then to support them in whatever informed decision they make. To do otherwise in my mind is contrary to the spirit of medicine and suggests one of two exceedingly common and unfair weight biases. First the one that often angrily asserts that unless a person is willing to make formative lifestyle changes, they're not worthy of being helped, or the second - that if only patients wanted it badly enough, they'd just fix themselves. Honestly, if desire were sufficient is there anyone out there who'd struggle with anything?

So is the Aspire Assist brilliant or brutal? Given it's just been born, it's going to be at least a decade before we'll even have the chance of having the robust long term data to make an informed decision. Until then all I can really say is that I'm looking forward to reading it.

I'd like to see numbers on the amount of patients who had aspire, remove it, and regain after a few years vs the regain numbers on traditional WLS patient.

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I don't want to offend anyone or be overly negative. But I have some questions (aspire users this is your opportunity to educate me) and some opinions as well. First, most of us are RNY, VSG, lapband. These surgeries force us in the short term relearn how we eat and many of us use therapy long term to deal with what makes us overeat or binge eating. Please someone describe how this device changes you mentally? Only those who make the mental shift are successful long term. Also do you have a Nut and will that be a standard of care .... Without restriction how are you learning better eating habits? What happens when the device is removed? Many many on this board have lapband removed and usually gain their weight back. What is the rate of regain after it is removed? What do the 5 and 10 year studies show? Finally my opinions. It will be hard for traditional WLS patients to get excited about this after seeing what our lapband sisters and brothers have been through. FDA approval does not impress us. Time and success will! Finally be please aware that is does gross us out the thought seeing stomach contents and if we are feeling this way the general public is going to be even more shocked and grossed out. All WLS patients need a thick skin.... And aspire patients may need to be thicker than most.

I don't want to offend anyone or be overly negative. But I have some questions (aspire users this is your opportunity to educate me) and some opinions as well. First, most of us are RNY, VSG, lapband. These surgeries force us in the short term relearn how we eat and many of us use therapy long term to deal with what makes us overeat or binge eating. Please someone describe how this device changes you mentally? Only those who make the mental shift are successful long term. Also do you have a Nut and will that be a standard of care .... Without restriction how are you learning better eating habits? What happens when the device is removed? Many many on this board have lapband removed and usually gain their weight back. What is the rate of regain after it is removed? What do the 5 and 10 year studies show? Finally my opinions. It will be hard for traditional WLS patients to get excited about this after seeing what our lapband sisters and brothers have been through. FDA approval does not impress us. Time and success will! Finally be please aware that is does gross us out the thought seeing stomach contents and if we are feeling this way the general public is going to be even more shocked and grossed out. All WLS patients need a thick skin.... And aspire patients may need to be thicker than most.

Hi all of You. Som questions to be answered. It is true that Aspire doesn't force users to eat better or less to Loos their weight. As all the restricted methods does. But we have seen, with our 165 patients over a time span of 4 years, that the users of Aspire can and will change eating behavior. It all comes down to chewing everything eaten to a size less that the inner diameter of the A-tube. When doing that, time to eat will be very much longer and you get satisfied with a lot less food that before. You eat less! Junk food taste awful so you stop eating a lot of those things. Instead of forcing people to eat less with restrictive surgery, Aspire gives a person the possibility to change eating behaviour over time. I strongly believe that if you have decided to once and for all loose weight and never regain it, you can change your eating behaviour. Aspire giver a person a chance to see the result 3 times a day. If you chew the food enough you can flush 30% out after each meal. If you don't chew enough, you can't flush. That is the therapy on the physical side. But, long term you will need a lot of support and for some also therapy. That goes for all the other surgical methods too, by the way. In Sweden we had a program to support our users and a secret Facebook account. All users can get a mentor, if they want and support each other. EWL first year is now 65% and stable after 4 years. No complications for any of our users. But, some said that they don't want to continue the use so they removed the A-tube and are back on sqare 1. Completely reversable. The mot important difference from the other surgical procedudures.