The AspireAssist is a new, reversible endoluminal weight loss device that induces weight loss in obese patients (BMI 35-55) by reducing caloric absorption and reducing eating rate. Using a modified PEG technology, the AspireAssist enables patients to remove up to 30% of stomach contents after a meal, in the privacy of a restroom. The device also requires that patients chew their food extensively to fit through the 6mm tube, resulting in more than a 2x increase in average meal consumption time1.
01: Dual Mechanism Weight Loss
CONTROL OVER RESULTS
About 20 to 30 minutes after each meal, patients attach the system to a discreet button on the abdomen. Stomach contents empty directly into a toilet. Patients clear any occlusions using water from the reservoir to flush the tube. After use, the device stores back in a small handheld case.
GRADUAL HEALTHY CHANGES
Successful patients use the device two to three times per day initially, and can reduce the frequency of use over time, as they approach their goal weight. Monthly lifestyle counseling sessions are required to reinforce healthy changes for sustainable weight loss.
02: Simple Procedure
The device is placed using the standard “pull” PEG technique by a trained endoscopist. Monitored Anesthesia Care (MAC) is typically used. The average procedure time is 15 minutes, and patients are typically discharged within 2 hours.
Transillumination is required to ensure safe placement of the tube. In the US Pivotal Trial, the tube was successfully implanted in 99% of patients during the initial procedure (110/111 procedures)². One patient required repositioning in a subsequent procedure to achieve transillumination, and the tube was successfully placed.
03: Clinical Results
The AspireAssist has been studied in several hundred patients across both the EU and US, with consistently excellent weight loss results.
Per-Protocol data above includes all treated subjects who completed the scheduled follow‐up visits up to and including 52 weeks.
Sources: US Pivotal Study: The PATHWAY Study (n=171), Per protocol population. Reference below. European data collected from Sweden, Spain, Czech Republic, Germany, Austria, Italy. N=80 at year 1 and n=25 at year 2 (ongoing studies, completers only included).
Percutaneous Gastrostomy Device for the Treatment of Class II and Class III Obesity: Results of a Randomized Controlled Trial. Thompson CC, Abu Dayyeh BK, Kushner R, Sullivan S, Schorr A, Amaro A, Apovian C, Fullum T, Zarrinpar A, Jensen M, Stein A, Edmundowicz S, Kahaleh M, Ryou M, Bohning JM, Ginsberg G, Huang C, Tran D, Martin J, Jaffe D, Farraye F, Ho S, Kumar N, Harakal D, Young M, Thomas C, Shukla A, Ryan M, Haas M, Goldsmith H, McCrea J, Aronne L. Am J Gastroenterol advance online publication, 6 December 2016. Download PDF or View Online.
Aspiration therapy leads to weight loss in obese subjects: a pilot study. Sullivan S., Stein R., Jonnalagadda S., Mullady D., Edmundowicz S. Gastroenterology 2013;145:1245–1252.
A novel endoscopic weight loss therapy using gastric aspiration: results after 6 months. Forssell H, Norén E. Endoscopy. 2015 Jan;47(1):68-71.
04: Track Record of Safety
Building on 35 years of clinical experience with PEG tubes, the AspireAssist has the lowest SAE rate of any FDA-approved endoscopic weight loss device at 3.6% in the US Pivotal study. All SAEs in the US study were treatable with medication or tube removal. All subjects were monitored closely for electrolyte and metabolic values, and no clinically-significant abnormal values were noted in any subject outside of normal lab variations. The most common adverse events were post-procedure pain, post-procedure nausea / vomiting related to the anesthesia, peristomal granulation tissue, and peristomal irritation.
In the US Clinical Study, 3.6% of subjects (4 out of 111) experienced a serious adverse event. These adverse events were (1) Peritonitis (mild pneumo‐peritoneum without abscess, 1 subject), treated with IV antibiotics, (2) Abdominal pain post‐procedure (1 subject), treated with pain medication, (3) Non‐bleeding pre‐pyloric ulceration (1 subject), treated with A-Tube removal, and (4) A-Tube replacement (1 subject). All SAEs were successfully treated without surgical intervention.
For complete safety information, please see the Instructions for Use.
05: High Patient Satisfaction
In a multinational survey, AspireAssist patients report high satisfaction with the therapy and would be very likely to recommend the therapy to a friend.1
06: Patient Monitoring
Patients must be monitored regularly for weight loss progress, stoma site heath, and metabolic and electrolyte balance. The device includes a Counter mechanism, allowing 115 uses before a new Counter must be issued by the clinician. This mechanism allows clinicians to track device usage and requires patients to return for follow-up.
07: Interested in Learning More?
If you are interested in the AspireAssist for yourself or a friend, please click here to find a physician in your area.
If you are a healthcare professional interested in using the AspireAssist in your practice, please call us at 877-312-0007 or complete the form below to have an Aspire representative contact you:
¹Self-reported; 2015 multinational survey of 63 AspireAssist patients in Sweden, Italy, and Spain.
²Excluding one subject where procedure was aborted due to suspected gastric varices, and one subject where procedure was aborted due discovery of a previous (undisclosed) Roux-en-Y gastric bypass surgery.
09: About the US Pivotal Study
The PATHWAY study was a randomized controlled trial conducted at 10 leading institutions across the US. 171 subjects were enrolled and randomized in a 2:1 manner to treatment and control arms, respectively. The treatment arm received the AspireAssist as well as lifestyle counseling. Study subjects randomized to the control arm received only lifestyle counseling. Study locations are listed below.
San Diego, California
Dept. VA Health Care System (Veterans Only)
Amir Zarrinpar, MD
Howard University Center for Wellness and Weight Loss Surgery
Terrence M Fullum, MD, FACS
St. Louis, Missouri
Washington University School of Medicine
Steven A Edmundowicz, MD
Mike Jensen, MD
New York, New York
Weill Cornell Medical College
Louis Aronne, MD
Boston Medical Center
Caroline Apovian, MD
Brigham and Women’s Hospital
Christopher Thompson, MD, MSc
Robert Kushner, MD
University of Pennsylvania
Anastassia Amaro, MD
St. Mary Medical Center
J. Matthew Bohning, MD and Alan B. Schorr DO FAAIM FACE