The US Food and Drug Administration (FDA) has approved the Spatz3 Gastric Balloon, an adjustable gastric balloon system, to aid in weight loss for adult patients struggling with obesity, Spatz FGIA Inc announces in a news release.

The Spatz3 is the fifth balloon to receive FDA approval, and FDA clinical trial results suggest a 15% decrease in weight and an 84% success rate.

The Spatz3 Adjustable Gastric Balloon

“We are proud of our FDA clinical trial results and look forward to bringing this proven technology to the US\ population. The Spatz adjustability function has raised the bar for gastric balloons and has resulted in impressive weight loss results and an outstanding 84% success rate.”

— Dr. Jeffrey Brooks, inventor of the Spatz3 adjustable balloon and CEO of Spatz FGIA Inc

Like other gastric balloons, the Spatz3 is inserted endoscopically while under conscious sedation. During the 15-minute non-surgical procedure, the balloon is placed in the stomach and inflated with saline, and the patient is discharged within 1 hour.

Once implanted, almost all gastric balloon systems lose efficacy by the fourth month, leading to weight loss plateau and weight regain while the balloon is implanted. In addition, abundant medical publications have reported that approximately one in ten gastric balloon patients face premature extraction in the first month due to intolerance, characterized by persistent nausea, vomiting or abdominal pain.

These two issues are addressed by the proprietary adjustment feature of the Spatz balloon, which enables the physician endoscopist the ability to change the balloon volume at any time during the treatment period. The balloon volume adjustment is performed in a 15-minute outpatient endoscopic procedure and is used in the following two scenarios:

  • A “down adjustment” to remove 100-150 ml from the balloon to alleviate intolerance and prevent early extraction
  • An “up adjustment” to add 200-300 ml to the balloon, which rejuvenates the balloon effect and affords the second round of weight loss

Clinical Study Results

In the US pivotal Spatz3 clinical trial, 288 patients suffering from obesity (Body Mass Index 30-40 kg/m2) were randomized to treatment or control, with two-thirds randomized to implantation with the Spatz balloon with diet and exercise and one third serving as control patients on diet and exercise alone. During the 14-month pivotal trial, all study endpoints were met.

Detailed findings of the trial revealed:

  • Spatz Balloon patients lost 15% of their initial weight compared with 3% weight loss in the control group – five times greater weight loss with Spatz3 Balloon.
  • Weight maintenance was measured for 6 months after balloon removal, with 74.3% achieving the weight loss maintenance endpoint.
  • The adjustment feature was used to reduce balloon volume for intolerant patients. Twenty-eight intolerant patients underwent down adjustments with removal of 150 ml. Intolerance was alleviated in 82% of these patients, allowing them to complete the entire 8-month treatment period.
  • At week 18 (+/- 4 weeks) up adjustments were performed in 71.7% of patients with the addition of 200-300 ml, resulting in additional loss of 15.2% of their excess weight after the 18-week adjustment.
  • The overall success rate, defined as achieving at least 10% weight loss, was achieved in 84% of patients.

[Source(s): Spatz FGIA Inc, PRWeb]