FDA OKs Haemonetics’ Global Hemostasis-HN Assay Cartridge

Haemonetics has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its TEG 6s hemostasis analyzer system Global Hemostasis-HN assay cartridge.
 
The new cartridge broadens the company’s TEG 6s viscoelastic testing capabilities to serve fully heparinized patients in adult cardiovascular surgeries/procedures and liver transplants in lab and point-of-care settings.
 
The cartridge-based TEG 6s system, according to Haemonetics, offers a complete picture of a patient’s coagulation profile, with quicker and more detailed information for actionable results compared to conventional coagulation testing. TEG Manager software supports the analyzer with remote, real-time viewing of results and interpretation guidance with customizable alert messages.
 
The FDA nod was supported by a 335-patient clinical trial of patients undergoing cardiac bypass surgeries, interventional cardiology procedures, or liver transplants. Another study was conducted with 164 healthy volunteers to establish the test cartridge’s normal reference ranges. The company said over 5,500 clinical data points were leveraged to determine safety and effectiveness.
 
“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 Haemonetics senior VP and chief medical officer Jan Hartmann, MD. “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 Haemonetics president of Global Hospital Stewart Strong. “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.”
 
Earlier this week, Haemonetics completed the $160 million deal to acquire Attune Medical, maker of the ensoETM proactive esophageal cooling device for RF cardiac ablation.