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Intragastric Balloons

No reports of deaths related to use of Obalon balloon system

. Obalon voluntarily established a Commercial Registry to track adverse events, product performance and weight loss in real time in patients receiving the Obalon Balloon

Obalon Therapeutics has commented on the advisory issued by the FDA in June concerning the potential risks, including deaths, associated with liquid-filled intragastric balloons. The advisory was specific to the Apollo Orbera and ReShape Duo intragastric balloons and does not reference or apply to the gas-filled Obalon Balloon System. Obalon has not received any reports of any deaths related to the use of Obalon Six-Month Balloon System since it was launched in January 2017.

“Our first concern is for the patients and families, as well as the health care professionals that care for these patients, who are impacted by these adverse events. Patient outcomes, especially safety, has always been the highest priority at Obalon,” stated Andy Rasdal, President and CEO of Obalon. “We believe we have a novel product that is performing very differently than the liquid-filled balloons and a team of people at Obalon who are responsibly and ethically building this important new therapy category for the treatment of obesity.”

The company stated that since launching the Obalon Balloon in January 2017, it has worked methodically and diligently in an effort to enable the best outcomes for patients. The company provides Obalon Product Specialists, whom are separate from the sales function, to help providers utilise the Obalon Balloon in a safe and effective manner. Obalon voluntarily established a Commercial Registry to track adverse events, product performance and weight loss in real time in patients receiving the Obalon Balloon.

In March 2018, Obalon voluntarily published a bulletin to health care providers, which was also reviewed with the FDA, summarising product and clinical events that occurred in the full year 2017 to help providers make the most informed decisions for their patients. Finally, the company continues to comply fully and in a timely manner with the FDA Medical Device Reporting (MDR) regulations and guidance so that any potentially serious events are readily accessible to providers and the public via the FDA website.

“Obalon has always believed that obesity is a serious chronic disease, which if left untreated, is the gateway to the progression of more serious health events, such as diabetes and cardiovascular disease,” added Amy VandenBerg, Vice President of Regulatory Affairs. “Based on the data collected in the Obalon Commercial Registry, as well as the low number of reported events , we believe the Obalon Gas-Filled Balloon is performing with the same strong safety profile as it did in our Pivotal Trial and provides an important treatment option for obese patients who cannot lose weight with diet and exercise alone.”

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