Brazil’s ANVISA Approves Allurion Gastric Balloon

Allurion has received ANVISA approval to market its gastric balloon technology in Brazil.
 
The Allurion Balloon—known in Brazil as the Elipse Balloon—is the first and only intragastric weight-loss balloon that is routinely placed and removed without surgery, endoscopy or anesthesia.¹ With its launch in Brazil, the Allurion Balloon is now available in 60 countries.

“Obesity represents one of the most significant health challenges in Brazil today,” Allurion Co-Founder/CEO Dr. Shantanu Gaur said. “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 prevalence of obesity in Brazil has increased from 11.8% in 2006 to 20.3% in 2019. By 2030, nearly 30% of Brazil’s adult population will be obese.** Consequently, Allurion estimates a total addressable market of roughly 1.3 million consumers in Brazil will be eligible for and may consider undergoing an Elipse implant.
  
“We are confident in our future success in Brazil, because we have three major advantages: the revolutionary, procedureless nature of our device, the comprehensive nature of our program which includes an AI-powered remote patient monitoring system and behavior change program that complements the device, and the experience we have assembled after treating over 100,000 patients around the world,” Chief Commercial Officer Benoit Chardon said.
 
 The company has demonstrated clear product-market fit in more than 50 countries to date and has grown top-line revenues by 100% year-over-year for the past six years. With launches this year in Australia, Canada, Mexico, India, and now Brazil, the company has nearly doubled its footprint in just the past 12 months.
 
“According to Secretária de Vigilância em Saúde, our local health surveillance agency, around ​20% of the adult population is currently living with obesity and an additional 36% are overweight,” said Dr. Eduardo Grecco, a gastric surgeon and endoscopist at Instituto Endovitta in São Paulo, Brazil. “That is almost 95 million people. We have seen an 80% increase in obesity in the past 10 years— especially among 25- to 45-year-olds.​ That has a knock-on effect on other conditions for which obesity is a major risk factor.”

The Allurion swallowable gastric balloon is the world’s first and only procedureless weight loss device. It does not require surgery, endoscopy or anesthesia for routine placement or removal.¹ In Brazil, it is indicated for adults with a body mass index (BMI) of 30-40. It comes as part of the Allurion Program, which supports patients to make positive lifestyle changes that result in long-term weight loss. The holistic program includes support from a doctor and nutritionist, as well as a suite of digital tools designed to help maximize success.
 
The Allurion Program is intended for people who are unable to achieve their weight-loss goals by dieting alone, and those who do not want to—or cannot—undergo invasive surgery or endoscopy. It may also be suitable for people who need to manage weight-related co-morbidities, such as diabetes, infertility, or cardiovascular disease.

Allurion is dedicated to ending obesity. The Allurion Program is a 360-degree weight loss experience featuring the Allurion Gastric Balloon, the Allurion Virtual Care Suite including the Allurion Mobile App for consumers, Allurion Insights for clinicians featuring the Iris AI Platform, and the Allurion Connected Scale and Health Tracker devices. Allurion is a trademark of Allurion Technologies, Inc. in the United States and countries around the world.
 
** Estivaleti, J.M., Guzman-Habinger, J., Lobos, J. et al. Time trends and projected obesity epidemic in Brazilian adults between 2006 and 2030. Sci Rep 12, 12699 (2022). https://doi.org/10.1038/s41598-022-16934-5 

Reference
¹ In rare cases, the Allurion Balloon may require endoscopic or surgical intervention for removal.