Device Name: Spatz3 Adjustable Balloon System
Author(s): Nicolas Fuentes, M.D, David Pechman M.D
Spatz FGIA Inc. received FDA approval for the Spatz3 Adjustable Balloon System on October 15th, 2021.
The Spatz3 Adjustable Balloon System is a single use endoscopically inserted silicone balloon that allows for inflation and deflation of a balloon, with saline, for up to 8 months, intended to aid in weight loss by reducing the stomach capacity.
The use of the device is indicated for adults with BMI 30-40 Kg/M2 who have failed a supervised weight loss program and needs to be used in conjunction to a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight loss maintenance.
The balloon is inserted under conscious sedation with an endoscope. The device is inflated with 400-550ml of Saline and 1% methylene blue. At the proximal end of the inflation tube there is a silicone funnel with a luer-lock valve, and the device is supplied with an extension tube that is connected to the valve on its distal end, with a 3-way stopcock. Following inflation, the extension tube is pulled out of the mouth, and disconnected from the valve and then replaced by the cap. The balloon can accommodate for 300 to 850ml and can have a “down adjustment” removing 100-150ml and an option of “up adjustment” adding 200-300ml.
Non-clinical performance studies were carried out to validate the integrity, durability, and strength of the whole system and all the goals were met. The Spatz3 Adjustable Balloon with Cap Assembly is classified as a permanent implant in contact with mucosal membrane and biocompatibility studies were performed and passed.
Clinical studies were performed to assess safety and effectiveness. The device showed to have a 3.7% device-related serious adverse event, being the most common nausea, vomiting, and abdominal pain and was deemed to have an acceptably safety profile. The patients undergoing a combination of Spatz3 Adjustable Balloon and dietary/exercise counseling showed a weight loss of 15.0% of their baseline weight compared to 3.3% weight loss in control subjects.
Contraindications to use the balloon include: prior esophageal, gastric, or duodenal surgery or pathology, prior GI surgery complications, chronic abdominal pain, inflammatory disease of the GI tract, including esophagitis, ulcer, Crohn’s disease, potential upper gastrointestinal bleeding conditions, insulin-dependent diabetes, inability to tolerate endoscopy, anatomic abnormalities of the GI tract, liver failure, pregnancy, breastfeeding patients, severe cardiopulmonary disease, autoimmune connective tissue disorder, and eating disorders.
FDA approve indications for use:
- BMI 35-40 Kg/M2
- BMI 30-34.9 with one or more major obesity-related comorbid conditions
- Failed supervised weight loss program