The Food and Drug Administration (FDA) has approved the Obalon Navigation System, which allows for the Obalon Balloon System to be placed without the use of x-ray.
The Obalon Balloon System is a swallowable intragastric balloon system that consists of a balloon folded inside a capsule. Previously, x-ray was used to image the device during placement. The new navigation system uses magnetic resonance, which can display real-time images of the balloon onto a computer screen.
Speaking about his experience using the system as part of a clinical trial, Dr Mickey Seger, of Texas Bariatric Medical Institute, San Antonio, TX said, “We especially appreciated the Obalon Navigation System’s dynamic 3D display during balloon placement, as opposed to the static 2D x-ray images we currently use.”
In addition, the Obalon Navigation System is intended for use with the new, automated Touch Inflation Dispenser. “The automated Touch Inflation Dispenser eliminates many of the connections and valves from the prior dispenser, which should reduce the potential for error during balloon placement and inflation,” added Dr Seger.
The navigation system is expected to be commercially available in the first quarter of 2019.
The system was approved in 2016 for temporary use to aid weight loss in adults with obesity (BMI 30–40kg/m2) who have failed to lose weight through diet and exercise.
For more information visit Obalon.com.