July 29 2015. WASHINGTON (Associated Press) — Federal health regulators on Tuesday approved an inflatable medical balloon that aids weight loss by filling up space in the stomach. The Food and Drug Administration cleared Reshape Medical’s Duo balloon as another option for millions of obese Americans who have been unable to lose weight via more traditional methods…. FDA Approves ReShape Medical Balloon for Weight Loss
August 6 2015. Apollo Endosurgery’s gastric balloon, Orbera, was approved by the FDA to assist obese adults with a body mass index of 30 to 40 to lose and maintain weight…. FDA Approves Apollo Endosurgery Weight Loss Balloon
The approvals of these two gastric balloons, that have been sold in Europe for 20 years and 7 years (Orbera and Reshape respectively), indicate that space filling bariatric treatment methods can meet US standards as safe and effective devices.
These FDA approvals validate the gastric filling treatment as advanced by PlenSat digestible balloons.
The company believes that successful completion of clinical studies and other regulatory activities will ultimately enable PlenSat digestible balloons to serve patients in the United States – the single largest market in the world.