Apollo gets Third Obesity Device Approval from US FDA
Published By : 07 Aug 2015 | Published By : QYRESEARCH
Apollo Endosurgery, the marketer of the Lap Band, has received approval from the US Food and Drug Administration for the latest obesity device called the Orbera Intragastric Balloon. The Lap Band, on the other hand, is considered to be the most successful weight loss medical device marketed in the United States.
The Orbera Intragastric Balloon by Apollo Endosurgery received approval from the US FDA to aid weight loss and maintenance for obese adults with a body mass index of 30 to 40. This is the third obesity approval from the agency in this year already. Yet another balloon based device by ReShape Medical received FDA approval last week. A controversial neurostimulation implant by EnteroMedics received FDA approval earlier in 2015.
Dr Christine Ren Fielding, a bariatric surgeon, commented in a statement from Apollo that the weight loss journey, for many, leaves patients with very less support and fewer options apart from exercise, diet, and traditional surgery. The Orbera Intragastric Balloon’s approval bridges the gap that exists in treatment options available today. it is also a thrilling development for those health care professionals who have dedicated themselves to developing or providing patients with options that are less invasive and can help them in attaining their long-term weight loss targets.
The Lap Band was first approved by the FDA in 2001. Apollo acquired that weight loss device as well as the Orbera Intragastric Balloon, which was at that time in an investigational phase, for a price of US$ 110 million from Allergan in December 2013.
A total of 5 obesity devices have received approval from the US FDA as of now. The innovative obesity drugs that were approved by the agency not so long ago were unable to generate remarkable sales owing to the lack of efficacy.