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Note: Ai sensi e per gli effetti dell’Art. 76 D.P.R. 445/2000 consapevole della responsabilità e delle conseguenze civili e penali previste in caso di dichiarazioni mendaci e/o formazione od uso di atti falsi, nonché in caso di esibizione atti contenenti dati non più corrispondenti a verità e consapevole altresì che qualora emerga la non veridicità del contenuto della presente decadranno i benefici per i quali la stessa è rilasciata confermo di essere un OPERATORE SANITARIO.
I contenuti presenti in questo sito contengono informazioni rivolte agli operatori sanitari, in quanto si riferiscono a prodotti rientranti nella categoria dei dispositivi medici che richiedono l’impiego o l’intervento da parte di professionisti del settore medico-sanitario.
Professionisti del settore sanitario
Trillium® Biosurface's structure mimics critical characteristics of the vascular endothelium.
Overview
Trillium®* Biosurface is a polymer coating with heparin applied to the blood-contacting surfaces of cardiopulmonary bypass devices. Its structure mimics critical characteristics of the vascular endothelium by providing a hydrophilic, negatively charged surface that features heparin.
View details – Read about the various properties of the Trillium Biosurface
Trillium Biosurface clinical and scientific findings published in peer-reviewed cardiovascular surgery, perfusion and scientific literature include:
Note: Citations with bold font represent clinical studies. Citations with standard font represent in vivo and in vitro studies.
Technology licensed under agreement from BioInteractions, Limited, United Kingdom.
For more details, download our product brochure below:
Trillium Biosurface brochure (PDF 1.2 MB)
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.
Okkema AZ, et al. Physical and blood contacting characteristics of propyl sulphonate grafted biomer. Biomaterials 1991;12:3-12.
Grasel TG, et al. Properties and biological interactions of polyurethane aniomers: effect of sulfonate incorporation. J Biomed Mater Res 1989;311-338.
Lelah MD, et al. Polyether-urethane ionomers: surface property/ex vivo blood compatibility relationships. J Colloid Interface Sci 1985;104:422-439.
Silver JH, et al. Anticoagulant effects of sulphonated polyurethanes. Biomaterials 1992;13:339-343.
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.
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.
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.
Dickinson T, et al. Trillium®-coated oxygenators in adult open-heart surgery: a prospective randomized trial. JECT 2002;34;248-253.
Baksaas ST, et al. In vitro evaluation of new surface coatings for extracorporeal circulation. Perfusion 1999;14:11-19.
Tevaeari HT, et al. Trillium coating of cardiopulmonary bypass circuits improves biocompatibility. Int J Artif Organs 1999;22:629-634.
Palanzo DA, et al. Effect of Trillium® Biopassive Surface coating of the oxygenator on platelet count during cardiopulmonary bypass. Perfusion 1999;14:473-479.
Cazzaniga A, et al. Trillium® biopassive surface: a new biocompatible treatment for extracorporeal circulation circuits. Int J Organs 2000;23:319-24.
Mueller XM, et al. Antithrombotic properties of trillium coated connectors. ASAIO J 2002;48:483-6.
van den Goor J, et al. Reduced complement activation during cardiopulmonary bypass does not affect the postoperative acute phase response. Eur J Cardiothorac Surg 2004;26:926-931.
Blood is naturally compatible with vascular endothelium, not artificial surfaces.
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
Biocompatible surfaces for Medtronic extracorporeal circulation technologies mimic critical characteristics of the vascular endothelium.
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.
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.
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.
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.
Baier RE , Dutton RC . Initial events in interactions of blood with a foreign surface. J Biomed Mater Res. 1969;3(1):191-206.
Paparella D, Yau TM , Young E. Cardiopulmonary bypass induced inflammation: pathophysiology and treatment. An update. Eur J Cardiothorac Surg. 2002 ;21(2):232-244.
Medtronic Italia S.p.A. Società a socio unico soggetta ad attività di direzione e coordinamento da parte di Medtronic PLC.
Cap. soc. € 1.200.487,00 - Codice fiscale, partita IVA e numero di iscrizione al Registro delle Imprese di Milano-Monza-Brianza-Lodi 09238800156 – REA MI – 1275682. Sede Legale e Uffici Via Varesina, 162 Edificio Raimondi - 20156 Milano.