Allurion Technologies Wins CE Mark for Elipse Gastric Balloon

Allurion Technologies Wins CE Mark for Elipse Gastric Balloon

Procedureless weight loss device offers a new treatment option for overweight and obese individuals.

By Allurion Technologies12.16.15
Allurion Technologies announced today that its Elipse Gastric Balloon has received a CE mark allowing sale of the product in the European Union. This is the company's first regulatory approval.

Elipse will initially be available in select leading weight loss centers in France, Italy and the United Kingdom. Elipse is not yet approved by the U.S. Food and Drug Administration and is not available for sale in the United States.

Dr. Shantanu Gaur, Allurion's co-founder and chief scientific officer, said "excess weight often has a profound impact on health and quality of life including work, relationships and self-perception." However, of the nearly 2 billion overweight and obese adults worldwide, less than 1 percent have embraced currently available surgical and endoscopic options. "Weight loss therapies that require surgery, endoscopy, or anesthesia are often too invasive and can be too expensive for people who might otherwise greatly benefit from them," Gaur noted.

Elipse is Allurion's flagship product and is the world's first procedureless gastric balloon, according to the company. Elipse is made of thin, flexible polymer film and is delivered in a swallowable capsule, eliminating the need for surgery, endoscopy or anesthesia. It remains in the stomach for four months, after which it automatically empties and is excreted naturally. Elipse will be provided by licensed physicians as part of a comprehensive weight loss program.

"Our procedureless gastric balloon offers a simple, safe and effective alternative," said Dr. Samuel Levy, Allurion's co-founder and president. "Elipse is a new way for overweight and obese individuals to take action."

Allurion has studied Elipse in individuals with a body mass index (BMI) between 27 and 40 to assess its safety and its effects on body weight, metabolic parameters and quality of life. Interim results from a clinical study in 34 individuals were presented recently at ObesityWeek, the annual conference of the American Society for Metabolic and Bariatric Surgery and The Obesity Society. Findings included an average weight loss of 10 kilograms (22 pounds), with participants losing 37 percent of their excess weight and eight centimeters off their waist circumference over the four-month treatment period. Participants also saw improvements in their triglycerides, hemoglobin A1c (HbA1c) and all aspects of quality of life. All balloons were safely and naturally excreted.

"Following six years of development, we are very excited to enter the next phase of our company's growth," said Jonathan Wecker, Allurion Technologies' CEO. "I am extremely proud of our team and thankful for the support of the many physicians and allied caregivers that have helped make Elipse a reality. Following initial release in Europe, we expect to offer Elipse in the Middle East and beyond in the months and years to come."

Founded in 2009 by two Harvard Medical School students, Allurion Technologies is dedicated to developing less invasive treatments for overweight and obese individuals. The company's flagship product, Elipse, is a procedureless gastric balloon that works by filling the stomach, slowing digestion, and enabling portion reduction. Allurion is funded by private investors and the Massachusetts Life Sciences Center.

Watch the video below to find out how the Elipse device works:

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