Allurion Technologies announced clinical results from two new studies on the Elipse Gastric Balloon recently during ObesityWeek 2020 the company reports in a media release.
The Allurion Program features the Elipse Balloon, a procedureless weight loss device. The balloon is designed to remain in the stomach for 4 months and is paired with a Bluetooth-connected scale and Allurion smartphone app and a supervised nutritional program.
Clinical Study Results
In Long-Term Efficacy of the Elipse Gastric Balloon System: An International Multicenter Study, Dr Roberta Ienca and colleagues report on 509 patients who received the Elipse Balloon and were followed for 1 year. After 4 months of Elipse Balloon treatment patients achieved weight loss of 14.4 ± 7.7kg or 13.9 ± 6.4% of total body weight. At 1-year follow-up, 95% of this weight loss was sustained.
In Sequential Elipse Balloon Treatment: 1-Year Weight Loss Results Approximates Bariatric Surgery Results, Dr Roberta Ienca and colleagues report on 42 patients treated with sequential Elipse Balloons. Between 1 and 5 months following the passing of the first Elipse Balloon, a second balloon was placed.
After 4 months, mean weight loss and percent total body weight loss were 14.7 ± 4.4kg and 14.4 ± 3.6%, respectively. The second balloon resulted in an additional 8.8 ± 5.7kg and 10.0 ± 6.5% weight loss, respectively. In total, sequential balloon treatment resulted in weight loss of 22.0 +/- 9.0kg or 22.8 +/- 8.8%, and a body mass index (BMI) decrease of 8.1kg/m 2 from baseline.
“Both of these studies demonstrate the potential that the Allurion Program has in providing consumers with long-term and sustainable results.
“Additionally, this data indicates that consumers can achieve life-changing results without needing to undergo surgery, endoscopy or anesthesia.”
— Dr Shantanu Gaur, co-founder and CEO of Allurion
“The clinical data presented at Obesity Week is reflective of the increasing demand for our product around the world.
“We have tripled the number of patients treated in the past year and have created a reputation for clinical results that providers and patients can trust.”
— Benoit Chardon, Executive Vice President Commercial for Allurion
[Source(s): Allurion Technologies, Business Wire]
Related Content:
FDA Warns of Overinflation, Acute Pancreatitis with Certain Intragastric Balloons for Weight Loss
Allurion Files for PMA Submission of Elipse Gastric Balloon
