Allurion has secured approval from Brazilian Health Regulatory Agency ANVISA to launch its gastric balloon technology in the country.
Known as the Elipse Balloon in Brazil, it is claimed to be the first and only intragastric weight-loss balloon in the world.
It can be placed and removed without the need for surgery, endoscopy or anaesthesia.
The technology is indicated for adult patients with a body mass index (BMI) of 30 to 40 in Brazil.
The balloon will be available as part of the Allurion Program, which motivates patients to make positive lifestyle changes for long-term weight loss.
The programme includes a suite of digital tools that are designed to increase success as well as support from nutritionists and doctors.
It has been designed for individuals who cannot lose weight through dieting alone and who do not want, or are unable, to have invasive surgery or endoscopy.
The Allurion Program can also be useful for people who need to manage co-morbidities related to their weight, which can include infertility, diabetes or cardiovascular disease.
Allurion co-founder and CEO Dr Shantanu Gaur said: “Obesity represents one of the most significant health challenges in Brazil today.
“We welcome ANVISA’s approval, and we look forward to working with healthcare professionals and other weight-loss experts to end obesity in the country.”
The Allurion Balloon is marketed in 60 countries following its launch in Brazil.
Brazil currently has five clinics that provide the Allurion Program, with seven more planned to open soon.
Over the last 12 months, Allurion has also launched its technology in Mexico, Canada, Australia and India.