Assess Hemocompatibility: Complement Biomarkers & Functional Assays

Medical devices such as grafts, stents, hemodialysis and cardiopulmonary bypass and catheters frequently interact with blood, a process that can initiate the body’s complement system response. If this system becomes dysregulated, it may lead to adverse reactions that negatively affect patient outcomes. Consequently, evaluating complement activation is a critical step in the design and evaluation process for these devices.

To understand complement activation, researchers rely on complement biomarkers, including the terminal complement complex (TCC). This biomarker provides insights into the activation pathways of the complement system. Additionally, functional assays, like those developed by Wieslab, assess the activity of the three distinct complement pathways. This is crucial for grasping the immune responses induced by medical devices.

Among these biomarkers, the Terminal Complement Complex (TCC) stands out for its ability to specifically indicate activation of the complement pathway, making it a reliable marker for assessing device-induced complement activation. Measuring TCC provides a clear picture of a device’s biocompatibility, which is essential for refining device design and selecting materials and functional assays can determine if any of the three pathways are activated.

Regulatory authorities underline the significance of complement assessment in the biocompatibility evaluations of medical devices. Standards and guidelines, including those specified in various ISO documents, set forth the requirements for biological evaluations. These include conducting complement activation studies to assure the safety and effectiveness of devices.

In the pursuit of enhancing device compatibility, research is geared towards discovering new methods to reduce device-induced complement activation. Strategies being explored include altering the surface of devices and using complement inhibitors to diminish immune reactions. These approaches aim to improve the hemocompatibility of devices, thus improving patient outcomes.

Complement biomarkers, particularly TCC, along with functional assays, are indispensable in the assessment of device hemocompatibility. Their use facilitates a thorough evaluation of the immune responses caused by medical devices. This is fundamental in enhancing patient care and the efficacy of devices used in medical treatments.