Werfen receives USFDA 510(K) clearance for ROTEM sigma

Werfen today announced the 510(k) clearance of the ROTEM sigma Thromboelastometry System by the US Food and Drug Administration (FDA). The ROTEM sigma delivers real-time, rapid and actionable results, now at the point of care (POC), to guide bleeding management. With clinical use throughout Europe, Australia, Asia, Latin America and Africa, the ROTEM sigma will be commercialized in the US in late 2022.

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. For a clear picture of coagulopathy, the ROTEM sigma 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.

“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.”

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, as well those from other networked systems in Werfen’s portfolio of Acute Care Diagnostics (ACD) 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. Additionally, GEMweb Plus 500 Custom Connectivity provides centralized access to results from any networked Werfen ACD system, including ROTEM sigma.
MB Bureau