Haemonetics receives FDA clearance for TEG 6s Global Hemostasis-HN cartridge

Haemonetics has received 510(k) clearance from the U.S. Food and Drug Administration 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. 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.