Allurion Technologies said yesterday it won CE Mark approval in the European Union for its Elipse gastric balloon used for weight loss.
The Elipse gastric balloon is made of thin, flexible polymer film and is ingested as a swallowable capsule, making its installation non-surgical. The balloon remains in the stomach for 4 months after which it automatically empties and is naturally excreted, the company said.
The device is for use in a combination with a comprehensive weight loss program, the company said.
“Excess weight often has a profound impact on health and quality of life including work, relationships and self-perception. 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,” chief scientific officer Dr. Shantanu Gaur said in a press release.
The Elipse will be initially available at weight loss centers in France, Italy and the U.K. The Elipse is not approved by the FDA.
“Following 6 years of development, we are very excited to enter the next phase of our company’s growth. 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,” CEO Jonathan Wecker said in a prepared statement.
In a study of 34 individuals with body mass indexes between 27 and 40, Allurion reported average weight loss of 22 pounds, with participants losing 37% of their excess weight and 8 cm off waist circumference during the 4-month treatment period.
“Our procedureless gastric balloon offers a simple, safe and effective alternative. Elipse is a new way for overweight and obese individuals to take action,” prez Dr. Samuel Levy said in prepared remarks.