The company agreed to suspend sales following a request from the National Medicines Safety Agency (ANSM) in the country. It now proceeds with the withdrawal of its devices from the market, pending the implementation of an action plan. ANSM requested a plan aimed at reducing certain risks linked to communication, follow-up and adverse events associated with the balloon.
Natick Massachusetts–based Allurion is the developer of an AI-powered gastric balloon for weight loss. The swallowable balloon requires no surgery, endoscopy or anesthesia. Once swallowed, the balloon fills and remains in the stomach for approximately four months before self-emptying and passing out naturally.
ANSM requested the withdrawal of the system due to adverse events linked to gastrointestinal complications, according to a news release. Allurion noted that the agency did not recommend the removal of balloons currently in place in treated patients. Those who benefitted from the balloon can continue treatment, the company said.
Allurion said it questions the agency’s decision, but remains fully cooperative with ANSM and has a risk reduction program in development.
“Patient safety and product quality are Allurion’s top priorities,” said Dr. Ram Chuttani, Allurion’s chief medical officer. “We are committed to strictly adhering to all regulatory requirements, relying on the most rigorous scientific evidence, and achieving the highest industry standards for our products. We will continue to work with the medical community and authorities regulatory requirements to implement our risk reduction plan and continue to serve our patients.”
Up to now, it’s been mostly positive for Allurion, which partnered with Medtronic on the platform last year. In April, it closed a $48 million financing to further advance its technology. In June, the company announced positive data for the balloon, too.
