Haemonetics Corporation Welcomes New FDA Guidance on Viscoelastic Testing During COVID-19 Pandemic
January 22, 2021 at 06:45 am EST
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Haemonetics Corporation issued by the U.S. Food and Drug Administration (FDA) related to the use of viscoelastic testing for the duration of the public health emergency related to COVID-19. Haemonetics is working expeditiously on fulfilling the requirements to modify the indications for the TEG® 5000 and TEG® 6s hemostasis analyzers and all related assays by amending product labeling and instructions for use, in line with the FDA guidance. This will allow healthcare professionals to begin using TEG® products for improved patient care during the pandemic. Haemonetics' TEG® 5000 and TEG® 6s hemostasis analyzers provide market leading viscoelastic tests. TEG® analyzers use whole blood, including platelets, and provide functional insights into the entire blood clotting process. For this reason, viscoelastic testing, such as the TEG® technology, has been recognized by the FDA as a potential adjunctive diagnostic to help better characterize COVID-19 associated coagulopathy (CAC) and to inform patient management, including personalized anticoagulation to reduce the risk of bleeding. CAC is characterized by hypercoagulability resulting from increased blood clot formation and impaired fibrinolysis, or the body's ability to resolve blood clots. This condition is common among COVID -19 patients and can lead to potentially deadly complications, such as venous thromboembolism, pulmonary embolism or stroke. Viscoelastic testing is used to analyze the ability of patients to form blood clots and to resolve them, and it provides holistic and unique insights beyond the information gained from conventional coagulation tests that each only look at one step in this process. This unique testing reviews the entire process, from the activation of the coagulation to the clot formation and ultimately to its resolution. In addition, viscoelastic testing uses whole blood from patients, as opposed to platelet-poor plasma like conventional tests, so it can provide more and valuable information, including about the contribution of platelets.
Haemonetics Corporation is a global healthcare company. The Company is engaged in providing a suite of medical products and solutions for customers, to help them improve patient care and reduce the cost of healthcare. Its technology addresses various medical markets, including blood and plasma component collection, the surgical suite, and hospital transfusion services. The Companyâs Plasma segment includes plasma collection devices and disposables, donor management software and supporting software solutions sold to plasma customers. Its Blood Center segment includes blood collection and processing devices and disposables for red cells, platelets and whole blood. The Companyâs Hospital segment consists of Interventional Technologies, which includes vascular closure devices and sensor-guided technologies, and Blood Management Technologies, which includes devices and methodologies for measuring coagulation characteristics of blood, and blood transfusion management software, among others.