Spatz FGIA Inc.

Spatz Medical manufactures and distributes the Spatz3 Adjustable Gastric Balloon, a weight-loss medical device designed for bariatric intervention. The Spatz3 is the only adjustable gastric balloon on the market, allowing physicians to customize balloon volume post-implantation to optimize patient comfort and sustained weight loss. The device can remain implanted for up to 12 months (twice the duration of competing non-US balloons), providing extended time for behavioral modification. Key clinical features include volume adjustment downward to address early balloon intolerance (~10% of patients) and upward adjustment at months 3–4 to overcome weight-loss plateaus and achieve additional excess weight loss (15.2% additional documented). Clinical data demonstrates highest-in-class weight loss outcomes (up to 34.7% total body weight loss) and success rates. The device is implanted via standard upper endoscopy under conscious sedation in approximately 15 minutes, with subsequent outpatient follow-up and dietary counseling to support long-term outcomes. The company operates globally across 80+ countries, with 160,000+ implantations worldwide and 3.9 million pounds of cumulative patient weight loss reported. The Spatz3 appears to carry regulatory clearance (FDA approval implied by US distribution and clinical trial data references), though specific 510(k) or CE mark status is not explicitly stated in the fetched content. The company provides patient education, success-story documentation, BMI-based eligibility screening, and an AI-assisted chatbot for inquiry support.