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Results from Spatz Medical FDA clinical trials confirm that Spatz3, the only Adjustable Gastric Balloon, delivers the highest success rates of all gastric balloons
GREAT NECK, N.Y., May 20, 2019 /CNW/ -- Spatz Medical today announced the FDA trial results of its innovative adjustable gastric balloon. The results demonstrate that the Spatz3 balloon is significantly more effective than any non-adjustable balloon in the market.
For the past 30 years, gastric balloons have helped hundreds of thousands of people lose weight with a 15-minute non-surgical out-patient procedure.
"The idea for developing an adjustable balloon was triggered by two main challenges the industry has been facing," says Dr. Jeffrey Brooks, CEO and inventor of the Spatz3 adjustable balloon.
❏ Roughly 10% of patients are intolerant to the balloon, requiring early extraction
❏ Gastric balloons lose their effectiveness by approximately the 4th month post-implantation, and studies have shown that patients actually regain weight while the balloon is still implanted
The Spatz3 patented adjustability feature overcomes these two shortfalls.
The FDA clinical trial results demonstrate how the adjustability feature helps intolerant patients avoid early extractions by reducing balloon volume. Furthermore, it proves that by increasing balloon volume after the 4th month, the Spatz3 balloon generated a 2nd round of weight loss. Together, these adjustability features result in:
- The highest weight loss of all gastric balloons, that underwent FDA trials
- The highest success rates of all gastric balloons, that underwent FDA trials
For the first time, a safe non-surgical out-patient weight loss treatment approaches the results of bariatric surgery.
SUMMARY OF FDA TRIAL RESULTS FOR THE SPATZ3 ADJUSTABLE BALLOON
The FDA trial demonstrates that the Spatz3 results were superior to the 4 other non-adjustable balloons.
The table below demonstrates the following average comparisons:
- The average success rate of non-adjustable balloons was 39.7%, while the Spatz3 was 83.7%
- The average Total Body Weight Loss (TBL) of Non-adjustable balloons was 8.3%, while the Spatz3 was 14.9%
- The average Excess Weight Loss (EWL) of Non-adjustable balloons was 29.4%, while the Spatz3 was 52.9%
- The average weight loss of Non-adjustable balloons was 17.8 lbs, while the Spatz3 was 31.7 lbs
- Following up-adjustment (balloon volume increase), patients lost an additional 14.7% of their Excess Weight
% TBL (Total
The FDA clinical results clearly indicate that the Spatz3 is the most effective and successful intragastric balloon available on the market and its clinical outcomes are superior to those achieved using non-adjustable balloons.
According to Dr. Jeffrey Brooks, CEO and inventor of Spatz: "We are dedicated to helping people lose weight and achieve their health goals. The FDA mITT trials (modified intention to treat) are considered the most reliable clinical data in the medical world. Since all 5 gastric balloons underwent the same stringent FDA process, the medical industry appreciates these as the closest to head-to-head comparisons. I take pride in the results that prove Spatz Adjustable Balloon procedure delivers the most effective, safe, non-surgical treatment for obesity to-date."
According to Ariel Nezry, VP Marketing at Spatz: "The outstanding results comparing Spatz to the competition (from 50% to 100% difference) confirm that the Spatz3 positions itself in a category of its own. Adjustability is a breakthrough for Spatz Medical and a huge benefit to patients and physicians seeking a safe and clinically effective solution to obesity. We look forward to expanding our foothold in the global market and reinforcing our position as the world's premiere developer of an adjustable balloon".
About Spatz Medical
Spatz FGIA, Inc. develops and markets the Spatz3, an all-new category of Adjustable, Gastric Balloons for the treatment of obese and overweight patients. The Spatz3 is the only volume-adjustable balloon system in the market that can remain in the patient's stomach for an extended period of time.
Disclaimer: The Spatz3 Device is currently under review by FDA and is not approved for sale in the United States.
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SOURCE Spatz Medical