Clinical data from a study conducted with 14 clinical sites presented recently at Obesity Weekend highlight the convenience, efficiency, and safety of Obalon’s proprietary Navigation and Touch Dispenser systems to achieve reliable balloon administration without the use of x-ray.
The study, presented by its co-primary investigator, Michael V. Seger, MD, FACS, FASMBS, Bariatric Surgeon at Bariatric Medical Institute (San Antonio), included 397 balloon administration assessments from 155 patients.
Rachel L. Moore, MD, FACS, FASMBS, bariatric surgeon at Surgical Specialists of Louisiana (Metairie, La) is the study’s co-primary investigator.
The co-primary endpoints of the Continuous Obalon Balloon Administration Location Tracking (COBALT) Study were met, with 100% correct decision-making for administering and inflating the Obalon Balloon System using the Navigation device instead of x-ray imaging. The study data also demonstrated 100% agreement between the Navigation System assessments and x-ray images collected but not used to make any decision to initiate inflation.
There were no serious adverse events observed in the study, and the overall adverse event rate was 3.9% with none of the events relating to the Navigation System or Touch Dispenser.
“These results suggest that the Navigation device can be used to safely and accurately administer Obalon Balloons without the use of radiography,” Seger says, in a media release from Obalon Therapeutics Inc, a vertically integrated medical technology company with reportedly the first and only FDA-approved swallowable, gas-filled intragastric balloon system for the treatment of obesity.
“Prior studies support the ability to achieve safe and effective weight loss with the Obalon Balloon System, and the use of Navigation can remove a key barrier to balloon administration when x-ray imaging is not accessible,” he adds.
The Obalon Navigation System provides treating physicians with the ability to place the Obalon Balloon without having to incur the costs and inconvenience of utilizing x-ray imaging. The Obalon Navigation System is a portable, easy to use, non-invasive, radiation free, self-contained imaging system that is FDA approved for dynamic tracking of the Obalon Balloon during balloon administration.
“These data demonstrate the robustness of our Navigation System, which like our gastric balloon, continues to perform well in clinical studies and in commercial use,” states Amy VandenBerg, chief clinical and regulatory officer of Obalo, in the release.
“We remain dedicated to improving the performance, usability and economics of the Obalon Balloon System and making this safe and effective technology more readily available to individuals with a BMI between 30 to 40 kg/m2 who are ready to lose weight and improve their overall health.”
[Source(s): Obalon Therapeutics Inc, GlobeNewswire]