This device used for any other purposes than for the indicated use is the responsibility of the user.
A strict anticoagulation protocol should be followed and anticoagulation should be routinely monitored during all procedures. The benefits of extracorporeal support must be weighed against the risk of systematic anticoagulation and must be assessed by the prescribing physician.
Federal law (USA) restricts devices coated with Cortiva™ BioActive Surface, Trillium Biosurface, or Balance Biosurface to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use that accompany each product.