Cartridge-Based Hemostasis Analyzer System Enables Faster Coagulation Testing

Haemonetics Corporation (Boston, MA, USA) has now obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their TEG 6s hemostasis analyzer system Global Hemostasis-HN assay cartridge. This latest cartridge broadens the scope of Haemonetics' TEG 6s system, enhancing viscoelastic testing for patients who are fully heparinized during adult cardiovascular surgeries/procedures and liver transplants, applicable in both lab and point-of-care settings.

Support for the 510(k) clearance came from clinical data obtained through a multi-center study involving 335 patients who were undergoing cardiac bypass operations, interventional cardiology procedures, or liver transplants. A separate study involving 164 healthy volunteers was also performed to determine normal reference ranges for the new test cartridge. In total, the safety and effectiveness of the Global Hemostasis – HN assays were substantiated with over 5,500 clinical data points.

The cartridge-based TEG 6s system from Haemonetics delivers a comprehensive overview of a patient’s coagulation profile, providing quicker and more detailed results that can be acted upon more efficiently than traditional coagulation tests. The TEG 6s analyzer benefits from the support of the TEG Manager software, which facilitates remote, real-time viewing of test results across the hospital and offers Interpretation Guidance with customizable alerts. Haemonetics is poised to launch this new Global Hemostasis-HN cartridge for the TEG 6s system in the coming months.

"TEG testing provides critical information that can help physicians improve hemostasis management for their patients, especially in critical situations like open heart and liver transplant surgeries and major trauma," said Jan Hartmann, MD, Senior Vice President and Chief Medical Officer at Haemonetics. "The Global Hemostasis-HN assay cartridge expands the benefits of TEG 6s system to patients on cardiopulmonary bypass or undergoing liver transplantation where heparin or endogenous heparinoids are present."

"Our market-leading TEG 6s platform has helped Haemonetics make effective and efficient viscoelastic testing more accessible throughout the world," added Stewart Strong, President, Global Hospital at Haemonetics. "With our new cartridge we look forward to expanding the impact of our Blood Management Technologies franchise through increased adoption of TEG 6s, and helping more clinicians improve patient outcomes and standards of care."