The CARMEDA® BioActive Surface is a clinically proven and long lasting thromboresistant heparin coating that actively prevents platelet adhesion and thrombus formation on medical device surfaces.
The following features and benefits of the CARMEDA® BioActive Surface have been shown in published clinical studies and scientific papers:
Thromboresistant - By suppressing the coagulation mechanism the CARMEDA® BioActive Surface reduces or eliminates thrombotic complications related to the exposure of blood to artificial materials (1, 2). The CARMEDA® BioActive Surface has been shown to effectively neutralize activated coagulation factors such as thrombin (3) and FXa (4). Studies have also revealed that the initiation mechanism of the coagulation system is suppressed by the bound heparin (5, 6). The CARMEDA® BioActive Surface also reduces the risk of thrombosis-related complications to a degree that allows decreased systemic anticoagulation (7, 8).
Luminal surfaces of artificial blood vessels after implantation in a challenging carotid shunt canine model. The upper image shows a material featuring the thromboresistant CARMEDA® BioActive Surface, which remains free of thrombus. The lower image shows a conventional artificial material, which is covered with thrombus.
Platelet compatible - The CARMEDA® BioActive Surface causes minimal activation and adhesion of platelets as demonstrated by in vitro (9, 10), in vivo (10,11) and clinical studies (12, 13).
Decreased inflammatory response - Several preclinical studies have shown near-elimination of complement activation in blood exposed to the CARMEDA® BioActive Surface (17, 18). Clinical studies have confirmed that medical devices with the CARMEDA® BioActive Surface cause less complement activation than uncoated devices (19, 12).
Reduced infection rates - Clinical studies have indicated a reduced infection rate in patients treated with central venous catheters with CARMEDA® BioActive Surface compared to uncoated catheters (20, 21). Hypothetically, due to the thromboresistant properties of the CARMEDA® BioActive Surface, the catheter surface is less likely to be fouled by clot-related material, making it less prone to support microbial growth.
Long lasting - The CARMEDA® BioActive Surface is a long-term, highly robust thromboresistant coating able to withstand all expected fluid flow conditions and many mechanical challenges. For example, the coating has been shown to remain bound and functional on explanted devices after months or even years of blood flow contact (14, 15). It also withstands, e.g. the mechanical challenge of balloon expansion of coronary stents in stenosed arteries (16, 10).
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