Important Safety Information
FDA Status Notice
ZeraFlow™ has not been cleared by the FDA and is not available for commercial use or sale in the United States. The system is currently within a Class II 510(k) regulatory pathway.
Observed Side Effects
The following clinical observations were documented in a published, peer-reviewed study evaluating a cohort of 125 consecutive patients¹:
Mild transient nausea: 1.6% incidence (n=2 of 125 patients)
Abdominal pain or cramping: 0% incidence
Temporary sensation of fullness: Occasional mild abdominal fullness reported during the procedure, which immediately resolved via the system's active drainage function.
Contraindications & Intended Safety Parameters
When available for clinical use, ZeraFlow is designed for prescription use only. The system is not appropriate for individuals presenting with any of the following medical conditions, where alternative clinical bowel preparation methods must be utilized:
- Active severe Inflammatory Bowel Disease (IBD) or acute diverticulitis
- Known or suspected bowel obstruction or gastrointestinal perforation
- Severe or uncompensated heart failure or renal insufficiency
Citation
Ziv Y, Scapa E. Techniques in Coloproctology. 2013;17:39-44. https://link.springer.com/article/10.1007/s10151-012-0876-8