US-based medical technology producer Allurion has secured approval from Brazilian Health Regulatory Agency ANVISA to launch its gastric balloon technology in Brazil.
The procedureless gastric balloon is said to be the world’s first and only intragastric weight-loss balloon. It is placed and removed without the use of surgery, endoscopy or anaesthesia for routine placement or removal.
Known as Elipse Balloon in Brazil, the technology is indicated for patients with a body mass index (BMI) of 30-40.
According to the firm, the balloon is a part of the Allurion Programme, which motivates adults to make positive lifestyle changes for long-term weight loss.
The programme also receives support from doctors, nutritionists and a suite of digital tools designed to maximise success.
Allurion said that the programme is designed for persons who cannot lose weight through food alone and who do not want to or are unable to have invasive surgery or endoscopy. People who need to manage co-morbidities connected to their weight, such as diabetes, infertility, or cardiovascular disease, may also find it useful.
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.”
With Brazil as the new location, the Allurion Balloon is now marketed in 60 nations. Brazil now has five clinics that provide the Allurion Programme, and seven more are on the verge of opening.
In more than 50 countries to date, the business has shown a clear product-market fit, and over the past six years, top-line revenues have increased by 100% annually.
With launches in Australia, Canada, Mexico, India, and now Brazil this year, the company’s global footprint has nearly doubled in the last 12 months alone, the medical technology firm noted.
