By taking up room in the stomach, the balloon creates a sensation of fullness and helps a patient eat less and develop habits of portion control.
A gastric balloon that’s swallowed like a pill and then sits in the stomach filled with fluid helped patients lose more than one-third of their excess weight over four months, researchers reported.
The Elipse device has not been approved for weight loss by the Food and Drug Administration (FDA). But it is one of a new generation of “gastric balloons” aimed at helping the overweight and obese lose weight and improve related health problems without undergoing an invasive and largely permanent replumbing of the digestive system.
In July, the FDA approved the “Reshape Dual Balloon” system, which is put in place during a 30-minute procedure during which a patient is mildly sedated.
The Elipse device, which is expected to come before the FDA for consideration soon, differs from the Reshape Dual Balloon in that it is swallowed rather than implanted into the stomach in an endoscopic procedure.
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The Elipse is enclosed in a capsule tethered to a thin, flexible tube long enough to remain outside the patient’s mouth once it is swallowed. Once in the stomach, the capsule’s shell dissolves. The released balloon is then filled up with buffered distilled water to roughly the size of a grapefruit via the catheter, which is removed through the mouth. No sedation is needed.
By taking up room in the stomach, the balloon creates a sensation of fullness and helps a patient eat less and develop habits of portion control. After about four months, the balloon automatically deflates, at which point it is expelled through the digestive system. After four months, the balloon is emptied and passed from the body in stool.
The device’s manufacturer, Allurion Technologies of Wellesley, Mass., calls the Elipse “the first procedure-less gastric balloon” and suggests it may be used to help those with a body mass index, or BMI, above 27 to lose weight.
A BMI of 25 is the cutoff point for overweight, and obesity is defined as a BMI above 30. The inclusion of nonobese patients in the population of the latest study suggests Allurion hopes to position the device as a treatment meant to prevent patients’ progression to obesity as well as to reverse it.
In research presented Thursday at the Obesity Society’s annual meeting in Los Angeles, study co-author Dr. Ram Chuttani reported that 34 overweight and obese subjects in Greece and the Czech Republic who got the balloon lost an average of 22 pounds after four months, roughly 37 percent of their excess weight.
Chuttani, chief of interventional gastroenterology at Beth Israel Deaconess Medical Center in Boston, said patients who got the Elipse also saw improvements in their triglycerides and in hemoglobin A1c levels, a key measure of metabolic function.
The current study, sponsored by Allurion, had no comparison group of subjects who got a placebo treatment. Gastric balloons are widely reported to cause stomach discomfort and some vomiting, at least in the initial days and weeks after they are implanted.
Researchers say that under the best of circumstances, the device won’t be available in the United States for two to three years.
Chuttani said that in addition to helping subjects feel full sooner, the Elipse appears to affect appetite, weight and physiological functions in some of the same ways that far more invasive bariatric procedures do.
In addition to reducing the stomach’s capacity, it appears to delay the process by which the stomach empties its contents and alters hormones that control hunger and appetite.
University of California, Irvine’s chief bariatric surgeon, Dr. Ninh Nguyen, cautioned that the gastric balloon is not a permanent solution to weight loss. But Nguyen, who was not involved in the study, said it may offer a treatment for overweight patients hoping to avert obesity, and to patients who may not be good candidates for bariatric surgery.
With nearly two-thirds of U.S. adults overweight or obese and obesity now considered a disease, the Obesity Society’s meeting this week highlights the clamorous effort to offer new treatments that are accessible to a wider range of patients.
Bariatric surgery’s Roux-en-Y gastric bypass, which surgically removes a part of the stomach and reroutes food around part of the intestine, is considered the most effective and enduring treatment of obesity and its related ills.
But that procedure’s cost, invasiveness and irreversibility — and the technical demands of doing the surgery — have left plenty of room for less radical and permanent treatments for obesity.
At this year’s meeting, researchers said that three years after it was first introduced in the United States, a less radical bariatric procedure called sleeve gastrectomy — which uses sutures to create a smaller stomach “pouch” — has overtaken Roux-en-Y as the most-performed weight-loss surgery.