Thromboelastometry System Enables Rapid Assessment of Critical Bleeding at POC

For a clear picture of coagulopathy, a novel thromboelastometry system provides at-a-glance assessment of clot firmness and stability, enabling hemostasis optimization, while minimizing blood loss. The result is a reduction in inappropriate transfusions, associated complications and cost—all essential to a successful patient blood management (PBM) program.

The ROTEM sigma Thromboelastometry System from Werfen (Bedford, MA, USA) delivers real-time, rapid and actionable results, now at the point of care (POC), to guide bleeding management. Built upon proven cup-and-pin technology, the ROTEM sigma leverages similar assays as its leading predecessor, the ROTEM delta Thromboelastometry System, used widely throughout North America and in thousands of peer-reviewed clinical studies.

ROTEM sigma is fully integrated and automated, cartridge-based, and simple to operate, making it ideal for POC testing. Large, easy-to-view TEMograms provide clear, real-time viscoelastic testing results, for enhanced, rapid interpretation. With a comprehensive assay menu, and four independent channels, the ROTEM sigma facilitates targeted therapeutic decisions in a variety of clinical settings. For critical procedures, including those requiring heparin neutralization, the ROTEM sigma complete + hep cartridge delivers intraoperative results in the cardiovascular surgery and liver transplantation.

Citrated whole blood arterial or venous samples require no incubation time and testing is initiated in minutes. Early validated parameters, such as A5, are delivered faster than traditional methods, with actionable results in less than 15 minutes - essential in critical bleeding scenarios. Ready-to-use, room-temperature cartridges with integrated closed-tube sampling simplify testing, saving time and standardizing the testing process.

Werfen's new GEMweb Live real-time onscreen viewer consolidates diagnostic test results from ROTEM thromboelastometry systems. Comprehensive, rapid test results, viewed on one screen, help guide goal-directed therapy and other critical intraoperative needs, before, during and after surgery, enabling faster clinical decision-making during cardiac surgery. Werfen has received 510(k) clearance from the US Food and Drug Administration (FDA) for the ROTEM sigma. With clinical use throughout Europe, Australia, Asia, Latin America and Africa, the ROTEM sigma will be commercialized in the US in late 2022.

"Reducing inappropriate transfusions is paramount in healthcare today for patient safety, to help preserve blood supply, and for cost containment. Incorporating ROTEM sigma testing into a PBM program allows hospitals to achieve these goals," said Remo Tazzi, VP, Worldwide Marketing and Service, Hemostasis and Acute Care Diagnostics at Werfen. "By viewing real-time, actionable results in the operating room, surgeons, anesthesiologists, and other clinicians can make faster and more informed transfusion decisions, improving patient outcomes and enhancing hospital efficiency."

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