FDA Clears Werfen’s ROTEM sigma Thromboelastometry System

Werfen has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its ROTEM sigma thromboelastometry system.
 
ROTEM sigma offers real-time, rapid, and actionable results at the point of care to guide bleeding management. It’s already used throughout Europe, Australia, Asia, Latin America, and Africa, and will be commercialized in the U.S. later this year.
 
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,” Remo Tazzi, VP, Worldwide Marketing and Service, Hemostasis and Acute Care Diagnostics at Werfen, told the press. “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.”
 
The system is integrated and automated, catridge-based, and simple to operate so it’s ideal for POC testing. Large, easy-to-view TEMograms provide clear, real-time viscoelastic testing results. It also has a comprehensive assay menu and four independent channels.
 
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.