Spatz Medical has announced the launch of the Spatz3 Adjustable Gastric Balloon in the US. The Spatz3 Adjustable Gastric Balloon, renowned as the first and only adjustable gastric balloon, has earned widespread acclaim for its outstanding weight loss results and an impressive 84% success rate, as demonstrated in the FDA Pivotal trials and real-world applications. Developed by Dr Jeffrey Brooks, CEO of Spatz Medical, the Spatz3 introduces a unique adjustability feature, allowing physicians to customise the balloon volume during the treatment period, addressing key challenges faced by traditional gastric balloon systems.
According to the company, the Spatz3's adjustability feature is a paradigm shift for intragastric balloons. It offers new possibilities for patients, including alleviating symptoms of balloon intolerance, preventing early intolerance with gradual filling of the balloon, and a rejuvenation option for those experiencing weight loss plateaus. The Spatz3 is approved for use in adults with obesity and provides a customizable approach to weight loss for individuals who have not achieved desired results through supervised weight control programs, or who have failed with standard non-adjustable balloons.
"The Spatz3 brings a new dimension in endoscopic bariatrics with its proprietary adjustability technology,” said Professor Abu Dayyeh (Mayo Clinic, Rochester, MN), Principal Investigator of the Spatz3 FDA Pivotal Trial and Post Approval Study stated. “The ability to change balloon volume during the course of treatment yielded an impressive 15% total body weight loss and 84% response rate in FDA clinical trials. Spatz will be an important and welcome addition to the endoscopic bariatric options in the US."
Clinical trial results from pivotal study demonstrated:
The Spatz3's efficacy and safety profile, as reported in the FDA Pivotal Study and published in The Lancet (Abu Dayyeh BK, et al. Adjustable intragastric balloon for treatment of obesity: a multicentre, open-label, randomised clinical trial. Lancet. 2021 Nov 27;398(10315):1965-1973), established a new threshold for Intragastric Balloon results.
Spatz3 Balloon patients achieved a 15% reduction in initial weight, in contrast to the control group's 3% weight loss.
74.3% of patients maintained clinically significant weight loss for six months after balloon removal.
The adjustability feature played a crucial role, with down adjustments alleviating intolerance in 82% of cases and up adjustments at 18 weeks resulting in an additional 15.2% excess weight loss.
The Spatz3 is approved for an 8-month treatment period, leading to more successful patient outcomes when compared to a standard, non-adjustable six-month balloon.
"The completion of the FDA Post Approval Study enrolment and the affirmation of our clinical trial results mark a pivotal moment for Spatz Medical. For the first time in gastric balloon history, an adjustable gastric balloon affords patients a decision making role in their weight loss therapy, customized to their needs,” said Brooks. “That is reflected in the outstanding 15% weight loss and 84% success rate, not previously achieved by gastric balloons in FDA trials. With a substantial global presence and over 150,000 patients benefiting from Spatz3, we are thrilled to bring this proven solution to individuals across the United States."
Over 150,000 patients have received the Spatz3 balloon in more than 60 countries.