Medical Device News Magazine

Allurion Receives Approval to Launch in Brazil

The world’s first and only procedureless gastric balloon receives approval from Brazilian Health Regulatory Agency ANVISA to launch in Brazil

About Medical Device News Magazine

About Medical Device News Magazine. We are a digital publication founded in 2008 located in the United States.

Advertise with Medical Device News Magazine! Join Our #1 Family of Advertisers!

We pride ourselves on being the best-kept secret when it comes to distributing your news! Our unique digital approach enables us to circulate your...

Allurion, a company dedicated to ending obesity, has received approval to launch its revolutionary 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 anesthesia1. With its launch in Brazil, the Allurion Balloon is now available in 60 countries.

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 have obesity**. As a result, Allurion estimates a total addressable market of around 1.3 million consumers in Brazil who would be eligible for and would consider choosing the Allurion Program.

Dr. Shantanu Gaur, Co-Founder and CEO of Allurion, says the need to address obesity in Brazil is more urgent than ever.

“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.”

Benoit Chardon, Chief Commercial Officer at Allurion, said the approval was just the latest move for the company into markets where obesity was a serious health challenge.

“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,” he says.

The Allurion Program is available in 5 clinics in Brazil, with 7 more to open soon. As with other markets, Chardon says Allurion will be selective at first in partnering with clinics to offer the program. “We want to guarantee best-in-class experience for all our patients: only the most experienced teams and clinics will be trained to deliver this sophisticated program,” he says.

The company has demonstrated clear product-market fit in over 50 countries to date and has grown top-line revenues by 100% year-over-year for the past 6 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.

Dr. Eduardo Grecco, a gastric surgeon and endoscopist at Instituto Endovitta in São Paulo, Brazil, welcomed an additional tool to help fight obesity.

“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. That is almost 95 million people,” he says.

“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.”

Dr. Manoel Galvao Neto, head of bariatric endoscopy of Mohak Bariatric and Robotics and scientific director at Instituto Endovitta, agrees. “It really is important that we act now to help these people lose weight. Having tools such as the Allurion Program at our disposal will be a game-changer.”

About the Allurion Balloon (marketed as the Elipse Balloon in Brazil)

  • 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 removal1. 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.

*Total market opportunity calculations are based on current health statistics, income levels and company market penetration

** 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).

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

Medical Device News Magazine
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Other News

Ultrahuman Announces its App Store ‘PowerPlugs’ with the World’s First AFib Detection Technology on a Smart Ring

Recognizing each individual’s health journey is unique, PowerPlugs enable people to choose and focus on the aspects of their health that matter most. It’s designed for highly personalized health insights, ensuring that every individual can personalize their health tracking to their unique needs and goals.

VisionAir Solutions Celebrates Milestone and New Collaboration

This achievement marks VisionAir Solutions commitment to bringing technological innovation to pulmonary medicine. Since its acquisition by Theken Companies last year, VAS has over doubled its growth and continues to demonstrate industry adoption and the advantages of personalized healthcare.

ArisGlobal Reports | Newest Version of LifeSphere® Regulatory Platform Launches

Ann-Marie Orange, CIO & Global Head of R&D shares, “With more than 35 years of experience in life sciences technology, ArisGlobal is the only technology company offering strong Safety, Regulatory, and Quality Management solutions powered with next-generation cognitive computing, delivering unmatched interoperability across the R&D IT ecosystem. Over the last 18 months ArisGlobal has made significant investment in the strategic acquisitions of Amplexor Life Sciences and SPORIFY, along with technology R&D – and we’re not stopping.”