Shantanu Gaur, MD, Samuel Levy, MD, Evzen Machytka, MD, Bruce Schirmer, MD, Daniel Jones, MD, George Blackburn, MD, PhD, Kathryn Stecco, MD. Allurion Technologies; University of Ostrava; University of Virginia; Beth Israel Deaconess Medical Center, Harvard Medical School.
The intragastric balloon (IGB) has been used effectively as a weight loss device for decades. Current generation IGBs require endoscopy for placement and removal and are typically left to reside in the stomach for six months. It is believed that IGBs work by occupying space within the stomach, inducing satiety, and making it easier for patients to adhere to a diet.
However, widespread use of current generation IGBs has been limited by several factors: (1) placement and removal endoscopies require sedation, special training, and equipment, thereby limiting the number of physicians who can deliver the device; (2) high cost and lack of reimbursement reduces patient demand; (3) weight loss plateaus after about 3 months while serious complications are more likely in the second 3 months of a 6 month IGB treatment; and (4) patients lost to follow-up are susceptible to IGB deflation and unplanned passage into the gastrointestinal tract.
The Elipse™ (Allurion Technologies, Wellesley, MA, USA) is a novel, naturally swallowed, self-emptying, and naturally excreted IGB that addresses these limitations. The Elipse™ balloon is enclosed inside a capsule and is attached to a thin, flexible tube long enough to remain outside the patient’s mouth once it is swallowed. After swallowing, the Elipse™ can be filled with 600mL of liquid in less than ten minutes without the use of anesthesia. When filling is complete, the tube is removed by pulling it back out through the patient’s mouth.
The Elipse™ is designed to remain in the stomach for 3 months at which point a self-releasing valve opens, allowing the Elipse™ to empty. The empty device is small, flexible, and smooth and soon passes out of the stomach and is excreted through the gastrointestinal tract. Once the Elipse™ has passed, the patient can return for another treatment if they desire additional weight loss. Compared to current generation IGBs, the ease of administration and the expected lower cost of the Elipse™ will enable repeat therapy that can be customized to individual weight loss needs.
Both in vitro and in vivo pre-clinical testing on the Elipse™ have been reported. In addition, a first-in-human pilot trial has been completed, demonstrating the feasibility, safety, and efficacy of Elipse™ treatment. Enrollment is ongoing to evaluate the Elipse™ in larger cohorts.