US-based Allurion Technologies has received the CE Mark, allowing the sale of its Elipse gastric balloon in the European Union (EU).
The Elipse gastric balloon, claimed to be the world's first procedureless weight loss device, offers a new treatment option for overweight and obese individuals.
Initially, the device will be available in select leading weight loss centres in France, Italy and the UK.
The device is not yet approved by US Food and Drug Administration (FDA) and is not available for sale in the US.
Allurion co-founder Dr Shantanu Gaur said: "Excess weight often has a profound impact on health and quality of life including work, relationships and self-perception.
"However, of the nearly two billion overweight and obese adults worldwide, less than one 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."
Elipse is made of thin, flexible polymer film and is delivered in a swallowable capsule, reducing the need for surgery, endoscopy or anesthesia. The company noted that Elipse remains in the stomach for four months, following which it automatically empties and is excreted naturally.
The device will be provided by licensed physicians as part of a comprehensive weight loss programme. The device has been tested in individuals with a body mass index (BMI) between 27 and 40 to evaluate its safety and its effects on body weight, metabolic parameters and quality of life.
Interim results from a clinical trial carried out in 34 individuals showed an average weight loss of 10kg, with participants losing 37% of their excess weight and eight centimeters off their waist circumference over the four month treatment period.
The device, offered by physicians in conjunction with a medically supervised diet and exercise programme, is swallowed in a capsule and filled with liquid through a thin delivery catheter, which is then detached.
Image: The Elipse capsule and balloon are shown next to a US quarter for size comparison. Photo: courtesy of Allurion Technologies.