Apollo Endosurgery said today it won FDA pre-market approval for its weight-loss focused Orbera intragastric balloon.
The balloon device is designed to be inserted non-surgically in obese patients with body mass indexes of 30 to 40, the Austin, Texas-based company said. After insertion, the balloon is inflated to fill space in the stomach.
“While new to the United States, Orbera is a weight loss device with more than 220,000 balloons distributed in over 80 countries and approximately 230 published papers documenting its clinical results. Orbera is a proven, innovative and non-surgical solution to help fight the obesity epidemic and treat patients before their disease progresses and requires more invasive treatments. With the FDA approval of Orbera, Apollo can now offer this safe and effective solution to patients and their physicians in the United States,” CEO Todd Newton said in a press release.
The Orbera is part of a managed weight loss system from the company which includes proper portion control, according to the company.
“For many, the weight loss journey leaves patients with little support or options other than diet and exercise and traditional surgery. The approval of Orbera fills this gap in available treatments and is an exciting development for healthcare professionals who are committed to providing patients with less invasive options that can assist them in reaching their long-term weight loss goals. Orbera gives us a new weight loss option to help address what has become a critical health issue in the United States,” Dr. Christine Ren-Fielding said in a press release.
Last month, the FDA cleared ReShape Medical’s dual balloon system, indicated to facilitate weight loss in obese adult patients, a system operating on similar principals to Apollo’s Orbera device..