EU approves Elipse Gastric Balloon to treat Obesity- Allurion Technologies
Allurion Technologies announced 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 centres in France, Italy and the United Kingdom. Elipse is not yet approved by the FDA and is not available for sale in the United States.
In a study of Elipse, 34 patients with a BMI of 27-40 kg/m2 had an average weight loss of 10 kg during the 4 month treatment period, with participants losing an average of 37% of their excess weight and 8 cm off their waist circumference. Patients also had improvements in levels of triglycerides and haemoglobin A1c (HbA1c) as well as all quality of life. All of the balloons in the trial were excreted safely.
Comment: Allurion’s Elipse is swallowed during a consultation and passes into the toilet some months later, thus avoiding surgery, endoscopy and anesthaesia.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.