Allurion Puts Consumers First with Weight Loss Balloon Treatment

Allurion Technologies is hoping to be able to get FDA approval to launch its obesity treatment balloon in 2020. The Natick, MA-based company said it was making progress toward its goal of getting Elipse on the U.S market by completing enrollment in the ENLIGHTEN clinical trial. The company exceeded its 400-patient target for the clinical study. “The reason we exceeded our target was because of the unprecedented demand that we experienced for the trial,” Shantanu Gaur, co-founder and CEO of Allurion, told MD+DI. “It was really astonishing to see the traffic numbers at our study website. All over the country people were clamoring to be a part of ENLIGHTEN. The response is supportive of our vision that [Elipse] isn’t just a balloon, but a frictionless weight loss experience that seems to appeal to both consumers and physicians.” Topline results from ELIGHTEN are estimated to be available in 2019. Allurion received CE mark for Elipse in 2015 and has treated more than 6,000 patients with the device. The company went on to say that the technology has been used in 100 weight loss centers in countries across Europe and the Middle East. The Elipse Balloon is made of a thin, flexible polymer film. The device is swallowed in a capsule and filled with liquid through a thin delivery catheter, which is then detached. The balloon remains in the stomach for about four months, after which it opens, allowing it to empty and pass naturally from the body without the need for a removal...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Business Source Type: news