New Weight Loss Balloon Approved By The FDA

By: 
True You
October 24, 2021

This week, the Food & Drug Administration approved Spatz3, the only adjustable gastric balloon system for weight loss. The Spatz3 balloon, which has been in use internationally for years, with almost 90,000 treatments, is now available in the United States. True You Weight Loss is proud to be a Spatz Medical partner and will be offering the Spatz3 balloon to patients in the very near future.

How it Works

Because the balloon is placed endoscopically (using a flexible camera that goes down the esophagus), Spatz3 and other gastric balloons must be placed by a board-certified gastroenterologist or a qualified bariatric surgeon endoscopist. The procedure is performed on an outpatient basis and takes approximately 15 minutes. Not unlike other balloons, Spatz3 is placed in its deflated form using an endoscope. Once it’s placed, the Spatz3 balloon is filled with saline and will sit in the stomach to provide a feeling of fullness, thereby restricting how much food a person can ingest.

As we see it, the Spatz3 balloon has three significant benefits worth highlighting.

1) It’s adjustable

The Spatz3 volume can be adjusted up or down, which offers numerous exclusive benefits.

  • For intolerant patients: Approximately 10% of patients who have a gastric balloon procedure become intolerant to the balloon. Their body simply doesn’t adjust to the foreign body, and they feel too ill to keep it in. For these patients, the ability to adjust the balloon “down” (removing some saline) will help alleviate intolerance in over 82% of the patients who down-adjust the balloon, rather than having it removed altogether. This is a significant benefit, particularly when considering the financial investment patients are making to have the balloon placed.
  • For patients who stall: In many cases, patients will stall or stop losing weight about 3-4 months after the balloon is placed. This is true for all gastric balloons on the market. Up-adjusting the balloon's volume (adding more saline) can help jumpstart weight loss once again, leading to greater overall success.

2) It can stay in longer

Gastric balloon placement, like any weight loss procedure, is just a tool. Successful patients are focused on making significant, long-term lifestyle changes that can be continued long after the balloon is removed. As we know, changing habits and lifestyle choices takes time. The benefits of having the Spatz3 remain in place for 8 months gives patients a little extra time to hardwire these changes into their daily routine. Most balloons feature a dwell time of 6 months, so the additional two months can have a significant impact on the long-term efficacy of the Spatz3.

3) It offers promising clinical trial results

The average percent of weight loss in FDA U.S. clinical trials for the Spatz3 was 15%, compared to roughly 6.6% to 10.2% for other balloons on the market. It also delivered higher total absolute weight loss (total pounds lost), with Spatz3 at 32 pounds on average, compared with approximately 14 to 22 pounds for other balloons. Finally, the Spatz3 success rate (defined as greater than 10% of total weight loss or 25% of excess weight) is nearly double the success rate seen with other non-adjustable gastric balloons, with Spatz3 delivering a success rate of 84% (vs. 25% to 46% with other leading balloons).

“This represents an exciting advancement in the field of endobariatric weight loss by delivering a more customizable balloon option,” explains Dr. Christopher McGowan, CEO and Medical Director of True You Weight Loss. “Current options offer a one-size-fits-all approach, but we know everyone’s bodies aren’t the same—and therefore, some patients will respond differently to the same procedure/device. With the Spatz3, we can make adjustments along the way that we hope will lead to better long-term outcomes and weight loss.”

Who is a Good Candidate for the Spatz3 Balloon?

The Spatz3 gastric balloon is designed for obese adults with a Body Mass Index (BMI) of 30 to 40 kg/m2, who haven’t been successful losing weight through diet and exercise.

Generally, patients who want a fully reversible weight loss option and are looking to lose 20-50 pounds would make great candidates for the Spatz3 balloon. The Spatz3 balloon doesn’t involve any long-term alterations to the stomach, and they are much safer than bariatric surgery with a risk of major complications of less than 0.03 percent. The best candidates are individuals who are very motivated to lose weight and are willing to make the long-term lifestyle changes needed to support sustainable weight loss.

To learn more about True You Weight Loss gastric balloon options, schedule a consultation

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