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



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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.

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I saw this on FB but I thought it was a joke lol

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After reading everyone's stories, I am still not convinced that this will work in the long term. What I can see this tool being used as, for patients that are 500 lbs or more, is a device to lose enough weight to have a safer WLS. I've seen the balloon used on The Fat Doctors in this way.

Edited by Evenya

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attachicon.gif 160614-aspire-bariatirics-inline-mdl_2c0b5783916fae2da3b8a5001af1a157.nbcnews-ux-2880-1000.jpg

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.

After reading all the responses on all 5 pages, im convinced that lots of people are pretty close minded and i wonder if you remember some of the negative and hurtful responses you got from some friends when you first decided on your WLS.

If this procedure is successful for many and is so very non invasive, i support it completely. Get over your pre conceived notions. The studies have been going for years now and it has proven to be both safe and effective. If it can help people to lose weight, and is safe, effective and proven through years of studies, i support it. Please, AA folks, keep writing about your experiences.

Triss

Sent from my SM-N920P using the BariatricPal App

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Lmao 😂 people crazy what's the point if you going to eat the same foods that made you the way you are. Soon as it come out what happens then. Oh ok😩

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I see this as “ purging “ without the esophageal burn.
Secondary bulimia


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