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Cortiva BioActive Surface
Biocompatible Surface for Cardiopulmonary Bypass Devices
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I contenuti presenti nella pagina che segue contengono informazioni rivolte esclusivamente 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
Biocompatible Surface for Cardiopulmonary Bypass Devices
Cortiva™ BioActive Surface* has the largest body of peer-reviewed clinical and scientific evidence of any biocompatible surface used for cardiopulmonary bypass devices today.
Cortiva BioActive Surface is a durable, non-leaching End Point Attached heparin coating technology that enhances blood compatibility and provides thromboresistant blood-contacting surfaces for cardiopulmonary bypass circuit devices. This heparin coating has the largest body of peer-reviewed clinical and scientific evidence of any biocompatible surface used for cardiopulmonary bypass devices today. From pediatric patients to adults, Cortiva BioActive Surface is an important component of routine as well as complex extracorporeal circulation procedures.
1. Prime Coat
Alternating layers of cationic and anionic polymers are deposited on the device surface via electrostatic adsorption to provide a consistent substrate that allows the Cortiva BioActive Surface to be applied to a variety of device materials, including plastics and metals.
2a. End Point Attachment Bonding Process
Heparin is bonded to the surface using End Point Attachment. End Point Attached heparin molecules are oriented to the blood in a manner similar to that of heparan sulfate naturally found on the vascular endothelium. The heparin molecules protrude into the blood, allowing their active sequences to interact with the blood. End Point Attachment of heparin results in a strong, covalent bond so that heparin does not leach from the surface during extracorporeal circulation in the presence of blood or albumin.
2b. Potent Surface Anticoagulant Activity
The End Point Attached heparin active sequence binds to antithrombin (AT) in the blood, resulting in a heparin-AT complex that has a much higher affinity for blood coagulation factors than AT alone. Attachment of activated blood coagulation factors to AT forms harmless inactive complexes that are no longer available to participate in or trigger other events in the coagulation cascade. For example, the activated blood coagulation factor II (thrombin) binds to the heparin-AT complex and subsequently becomes inactivated.
2c. Intact End Point Attached Heparin Molecule
The End Point Attached heparin molecule is not consumed by this cycle and remains bonded, intact, to the material surface. Its anticoagulant active sequence is then free to attach to another AT molecule.
2c. Neutral AT-Thrombin Complex
AT-coagulation factor complexes are then released from the immobilized heparin and are swept away from the surface by the flowing blood. These complexes are eventually metabolized by the body.
Cortiva BioActive Surface is the most extensively researched biosurface for today's extracorporeal circulation technologies, with extensive publication of clinical and scientific evidence in peer-reviewed cardiovascular surgery, perfusion and scientific literature, including:
Note: Citations with bold font represent clinical studies. Citations with standard font represent experimental in vitro and in vivo studies.
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.
Cortiva™ BioActive Surface, formerly marketed under the Carmeda® brand name. Carmeda is a registered trademark of Carmeda AB (Sweden).
Trillium Biosurface technology is licensed under agreement from BioInteractions, Limited.
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