Obalon Gas-Filled Balloon Not Subject of Fourth FDA Letter to Health Care Providers Related To Serious Risks, Including Death, With Liquid-Filled Intragastric Balloons
The Obalon swallowable, gas-filled balloon system utilizes a very different design and technology than the liquid-filled balloons cited now in four FDA letters to health care providers. The Obalon balloon is filled with a proprietary patented blend of gases, not simply air, making it light and buoyant and allowing it to reside in the upper portion of the stomach. Additionally, the Obalon balloon is constructed of novel, patented polymers that are designed to be semi-compliant (less stretchy) and to maintain its initial size and shape.
“We believe the Obalon balloon continues to perform differently than the liquid-filled balloons cited in this most recent FDA letter to healthcare providers, due to its novel design,” said
Obalon has reported to the FDA the results of the first 141 patients to complete therapy in its FDA-required Post-Approval Study. There were no device-related serious adverse events (0%) reported in those 141 patients. An 8.9% device-related serious adverse event rate was reported for the Orbera® liquid-filled balloon in their Post-Approval Study (equivalent to 89 events for every 1,000 patients).
“Recently published data suggests that next to age, the underlying health conditions of obesity and obesity-related health conditions (hypertension and diabetes) are the greatest predictors of COVID-19 hospitalizations and death in
Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements that are not purely historical regarding Obalon’s or its management’s intentions, beliefs, expectations and strategies for the future, including those related to new products and their potential benefits. All forward-looking statements and reasons why results might differ included in this press release are made as of the date of this release, based on information currently available to Obalon, deal with future events, are subject to various risks and uncertainties, and actual results could differ materially from those anticipated in those forward looking statements. The risks and uncertainties that may cause actual results to differ materially from Obalon’s current expectations are more fully described in Obalon’s annual report on Form 10-K for the period ended
President and Chief Executive Officer
Office: +1 760 607 5103
Source: Obalon Therapeutics, Inc.