The FDA has approved the Spatz Medical’s Spatz3 Gastric Balloon, the first adjustable gastric balloon system, to aid in weight loss for adult patients struggling with obesity. The Spatz3 is the fifth balloon to receive FDA approval and its pivotal FDA clinical trial results demonstrated a 15% decrease in weight and an 84% success rate. Although new to the US, the Spatz Balloon has already been implanted in almost 100,000 patients in over 40 countries and as shown in the FDA study, its distinctive and unique adjustability feature has created an effective and safe weight loss therapy, the company stated.
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 one hour.
In the last four decades, the world has seen over 500,000 gastric balloons implanted and that experience, as documented in the medical literature, has shown that almost all gastric balloon systems lose efficacy by the fourth month, leading to weight loss plateau and weight regain while the balloon is implanted, the company stated. 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, characterised by persistent nausea, vomiting or abdominal pain.
According to Spatz, these two issues are addressed by the proprietary adjustment feature of the Spatz balloon, which enables the physician endoscopist with 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
“We are proud of our FDA clinical trial results and look forward to bringing this proven technology to the US population. FDA clinical trials are among the most respected because they are performed under stringent conditions - intention to treat,” explained Dr Jeffrey Brooks, inventor of the Spatz3 adjustable balloon and CEO of Spatz FGIA. “This means every patient that is treated is accounted for and cannot be lost to follow-up, offering a true representation of results. 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.”
Clinical study results
In the US pivotal Spatz3 clinical trial, 288 patients suffering from obesity (Body Mass Index 30-40 kg/m2) were randomised to treatment or control, with two-thirds randomised 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 six 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.
“A different paradigm is emerging for the management of obesity…to improve or resolve obesity-associated comorbidities,” said Professor Barham Abu Dayyeh, Professor of Medicine, Director of Advanced Endoscopy, and Vice Chair of Innovation for the Department of Medicine at the Mayo Clinic. “The adjustability feature of the Spatz3 balloon and longer treatment duration maximizes patients’ tolerance and uniquely positions this technology to offer a safe and effective modality to manage obesity in conjunction with a robust lifestyle intervention programme.”