The Spatz 3 adjustable gastric balloon was approved by the FDA in the United States in 2021. It is indicated for patients with a body mass index (BMI) of 35-40, or a BMI of 30-35 with an obesity related medical issue. Spatz 3 has been available outside the US for some time, and over 100,000 have been implanted.
What makes the Spatz unique is that it is the only adjustable balloon system. This is important for several reasons:
- One of the most common complications for traditional saline-filled balloons is balloon interolerance. This means that a small percentage of patients will not tolerate their balloon and will have ongoing issues with vomiting and discomfort. In the past, if these issues persisted beyond a week or so then the balloon was typically removed early. With the Spatz however, some saline can be removed from the balloon which will usually cause these issues to resolve without balloon removal. This does require a repeat endoscopy, however.
- Another issue with saline balloons in the past is that some patients will only lose weight for the first few months. These patients will either have a weight loss plateau or even weight gain. If this occurs with a Spatz, some additional saline can be added to the balloon which will usually lead to additional weight loss. This also requires a repeat endoscopy.
An additional benefit of the Spatz is that it can be left in the stomach for 8 months, as opposed to a maximum of 6 months for other saline gastric balloons that have been approved in the US.
These advantages have resulted in significantly better weight loss and long-term success for the Spatz balloon in their FDA trial than for any other gastric balloon, whether saline or gas-filled.
As can be seen in the above table comparing all gastric balloons with which we have experience, the Spatz has not only the best weight loss, but also the highest success rate.