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Apr 27, 2023Haemonetics wins FDA clearance for hemostasis cartridge
Oct 16, 2024April 4, 2024 By Sean Whooley
Haemonetics (NYSE: HAE) + announced today that it received FDA 510(k) clearance for its TEG 6s hemostasis analyzer system assay cartridge.
The new cartridge extends Haemonetics’ TEG 6s viscoelastic testing capabilities. It can now serve fully heparinized patients in adult cardiovascular surgeries/procedures and liver transplantation in both laboratory and point-of-care settings.
Dr. Jan Hartmann, SVP and chief medical officer at Haemonetics says TEG testing provides critical information. This information can help physicians improve hemostasis management for patients, especially in critical situations.
“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,” Hartmann said in a news release.
The TEG 6s system provides a complete picture of a patient’s coagulation profile to help understand the complete hemostasis status. It offers faster, more detailed information for actionable results compared to conventional coagulation testing. Haemonetics’ TEG Manager software supports the analyzer with remote, real-time viewing of the results throughout the hospital.
According to a news release, Haemonetics plans to release the new cartridge in the coming months. The company supported its FDA clearance with data from a multi-center trial of 335 patients. Those patients underwent cardiac bypass surgeries, interventional cardiology procedures or liver transplantations.
“Our market-leading TEG 6s platform has helped Haemonetics make effective and efficient viscoelastic testing more accessible throughout the world,” said 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.”
Filed Under: 510(k), Blood Management, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: FDA, Haemonetics