Balance Biosurface

Why Use?

Why Use Biocompatible Surfaces for Extracorporeal Circulation Circuits?

Blood is naturally compatible with vascular endothelium, not artificial surfaces.

• Blood is compatible with the healthy vascular endothelium, a single layer of cells that lines all blood vessels and the heart.
• The endothelium plays an active biological role in maintaining homeostasis, or a balance, among the various body defense systems in a manner that simultaneously provides a state of readiness and avoids the trigger of adverse responses.^1,2
• The blood-contacting surfaces of endothelial cells are highly negatively charged, a characteristic that may repel the negatively charged platelets and be important in limiting the hemostatic reaction.³

Blood recognizes the extracorporeal circuit surfaces as “foreign”, triggering coagulation and inflammatory events that may lead to adverse patient outcomes.

Responses to Blood-Material Contact

• Within seconds of blood exposure to artificial, non-endothelial surfaces, there is a rapid adsorption of proteins from the blood onto the surface of the foreign material.⁴
• Adsorption onto a surface may result in protein denaturation, such as the denaturation of adsorbed fibrinogen, and ultimately lead to activation of the plasma proteolytic systems.¹ Subsequent events, including cell adhesion, are mediated by the adsorbed protein layer.¹
• The blood’s formed elements and other specific protein groups in the blood that are associated with the body’s defense systems may then interact with the material and its new protein layer.^1,2
• Ultimately, the biological reactions associated with the defense systems may affect the heart, lungs, brain and other organs, causing conditions that have been described as the “systemic inflammatory response syndrome.” ⁵

Biocompatible surfaces for Medtronic extracorporeal circulation technologies mimic critical characteristics of the vascular endothelium.

• These coatings mitigate the foreign body response that occurs when blood comes in contact with non-endothelial surfaces.
• Around the world, leading cardiovascular surgery teams adopt coatings surfaces offered by Medtronic as a critical component of comprehensive, multi-modal strategies to achieve the best possible outcomes for their patients undergoing extracorporeal circulation.

Warnings: 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.

Caution: Federal law (USA) restricts devices coated with Cortiva™ BioActive Surface, Trillium Biosurface and 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 which accompany each product.