Haemonetics Corporation announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the TEG®? 6s hemostasis analyzer system Global Hemostasis-HN assay cartridge. This new cartridge extends Haemonetics' TEG 6s viscoelastic testing capabilities to serve fully heparinized patients in adult cardiovascular surgeries/procedures and liver transplantation in both laboratory and point-of-care settings.

Understanding a patient's complete hemostasis status quickly can have a significant impact on clinical outcomes and use of blood products. Haemonetics' cartridge-based TEG 6s system provides clinicians a complete picture about a patient's coagulation profile, with faster, more detailed information for actionable results compared to conventional coagulation testing. The TEG 6s analyzer is supported by TEG Manager®?

software that enables remote real-time viewing of results throughout the hospital, as well as Interpretation Guidance with customizable alert messages. Haemonetics is planning to release the new Global Hemostasis-H N cartridge for TEG 6s system in the coming months. The 510(k) clearance was supported by clinical data from a multi-center trial that included 335 patients undergoing cardiac bypass surgeries, interventional cardiology procedures or liver transplantations.

An additional study was conducted using 164 healthy volunteers to establish the normal reference ranges for the test cartridge. Overall, over 5,500 clinical data points were used to demonstrate safety and effectiveness of the Global Hemostasis - HN assays.