Balance Biosurface

Balance Biosurface

Balance® Biosurface provides reduced platelet activation and adhesion and preserves platelet function with a non-heparin coating.

Overview

Balance® Biosurface is a hydrophilic polymer coating without heparin for cardiopulmonary bypass circuit devices. This coating reduces platelet adhesion and activation and preserves platelet function. Representing Medtronic’s commitment to perfusion solutions, Balance Biosurface expands options used by cardiovascular surgery teams for comprehensive strategies to achieve the best possible outcomes for their patients undergoing cardiopulmonary bypass.

Hydrophilic Polymer Coating Without Heparin

balance-biosurface-med 

View details – Read about the various properties of Balance Biosurface

 

For more details, download our product brochure below.
Balance Biosurface product brochure (PDF, 3.6 MB).

Balance® is a trademark of Medtronic, Inc. Technology licensed under agreement from BioInteractions, Limited, United Kingdom.
See graph below.

Balance Biosurface Functional Platelets Chart - Balance Coated vs Uncoated

Comparison between Balance-coated and uncoated in vitro bench test circuits of percentage of platelets that are activated with adenosine diphosphate (ADP @ 20 µM) in circulating heparinized human blood over time. Balance Biosurface is associated with a greater percentage of functional platelets (‡ p < 0.02 at 10, 30, 60 and 120 minutes).

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 Carmeda 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.

References

  1. Okkema AZ, et al. Physical and blood contacting characteristics of propyl sulphonate grafted biomer. Biomaterials 1991;12:3-12.
  2. Grasel TG, et al. Properties and biological interactions of polyurethane aniomers: effect of sulfonate incorporation. J Biomed Mater Res 1989;311-338.
  3. Lelah MD, et al. Polyether-urethane ionomers: surface property/ex vivo blood compatibility relationships. J Colloid Interface Sci 1985;104:422-439.
  4. Silver JH, et al. Anticoagulant effects of sulphonated polyurethanes. Biomaterials 1992;13:339-343.
  5. Charef S, et al. Heparin-like functionalized polymer surfaces: discrimination between catalytic and adsorption processes during the course of thrombin inhibition. Biomaterials 1996;17:903-912.
  6. Han DK, et al. Heparin-like anticoagulant activity of sulphonated poly(ethelene oxide) and sulphonated poly(ethylene oxide)-grafted polyurethane. Biomaterials 1995;16:467-471.
  7. Santerre JP, et al. Effect of sulfonation of segmented polyurethanes on the transient adsorption of fibrinogen from plasma: possible correlation with anticoagulant behaviour. J Biomed Mater Res 1992;26:39-57.

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.

cardiopulm-prods-whyuse

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 Carmeda 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.

References

  1. Lamba NMK, Cooper SL. Interaction of blood with artificial surfaces. In: Coleman RW, Clowes AW, George JN, Hirsh J, Marder V, eds. Hemostasis and thrombosis: Basic principles and practice, 4th ed. Philadelphia: Lippincott Williams & Wilkins, 2001:661-672.
  2. Edmunds LH, Stenach N. Blood-surface interface. In: Gravlee GP, Davis RF , Jurusz M, Utley JR, eds. Cardiopulmonary bypass: Principles and practice, 2nd ed. Philadelphia: Lippincott Williams & Wilkins, 2000:149-166.
  3. Coleman RW, Clowes AW, George JN, Hirsh J, Marder V. Overview of Hemostasis. In: Coleman RW, Clowes AW, George JN, Hirsh J, Marder V, eds. Hemostasis and thrombosis: Basic principles and practice, 4th ed. Philadelphia: Lippincott Williams & Wilkins, 2001:3-16.
  4. Baier RE , Dutton RC . Initial events in interactions of blood with a foreign surface. J Biomed Mater Res. 1969;3(1):191-206.
  5. Paparella D, Yau TM , Young E. Cardiopulmonary bypass induced inflammation: pathophysiology and treatment. An update. Eur J Cardiothorac Surg. 2002 ;21(2):232-244.
Last updated: 10 Aug 2012

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