Werfen Introduces New Acute Care Diagnostic Products for CVOR at AACC 2022

By Carolyn Moody, RN - News Editor
Posted on 27 Jul 2022

Image: ROTEM sigma thromboelastometry system has received US FDA 510(k) clearance (Photo courtesy of Werfen)

Werfen (Barcelona, Spain) will be introducing key innovations for the cardiovascular operating room at the 73rd AACC Annual Scientific Meeting & Clinical Lab Expo.

At AACC 2022, Werfen will introduce the new ROTEM sigma Thromboelastometry System that 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. 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. ROTEM sigma is fully integrated and automated, cartridge-based, and simple to operate, making it ideal for POC testing. Werfen has received 510(k) clearance from the US Food and Drug Administration (FDA) for the ROTEM sigma Thromboelastometry System. With clinical use throughout Europe, Australia, Asia, Latin America and Africa, the ROTEM sigma will be commercialized in the US in late 2022.

Werfen will also introduce the new GEM Hemochron 100 whole blood hemostasis system which leverages leading Hemochron technology to deliver fast, actionable activated clotting time (ACT) results in minutes, informing patient-management decisions and helping improve workflow at the POC. Producing ACT results faster than traditional systems, the GEM Hemochron 100 system optimizes heparin dosing and enables rapid initiation of critical procedures for enhanced patient management. Cartridge-based technology reduces time and complexity of testing, as well as the need for training and maintenance. Additionally, an intuitive user interface and large touchscreen allow simple operation for workflow efficiency. The GEM Hemochron 100 is designed for invasive procedures requiring heparin dose adjustment, where rapid and accurate ACT results are essential. Two ACT tests, ACT+ for moderate-high heparin doses (1–6 IU/mL) and ACT-LR for low-moderate (up to 2.5 IU/mL) heparin doses, offer testing flexibility in a variety of clinical settings, including the cardiovascular operating room (CVOR), cardiac catheterization lab, electrophysiology lab and intensive care units. The GEM Hemochron 100 system has also received 510(k) clearance from the US FDA and is currently in clinical use in several European countries.

In addition, Werfen has announced the worldwide commercial release of GEMweb Live, a real-time onscreen viewer of diagnostic test results for cardiac surgical procedures. Comprehensive, rapid test results are viewed in real-time on one screen, designed to help guide goal-directed therapy and other critical needs - before, during and after surgery. A digital solution, GEMweb Live coordinates care, enabling time-critical clinical decisions in the cardiovascular operating room (CVOR) by displaying consolidated results. Acute Care Diagnostic systems that can be connected to GEMweb Live include: VerifyNow platelet-reactivity system; ROTEM sigma and delta thromboelastometry systems; GEM Premier 5000 blood gas testing system; and GEM Hemochron 100 and Hemochron Signature Elite whole blood hemostasis systems.

A multidisciplinary approach to patient management, GEMweb Live supports operational efficiency during time-sensitive procedures such as cardiac surgery. Platelet function, from VerifyNow, is demonstrated to help identify bleeding risk from antiplatelet therapy (e.g., clopidogrel); blood viscosity, from ROTEM delta and sigma, is demonstrated to help guide transfusion decisions perioperatively; total hemoglobin, from GEM Premier 5000, is demonstrated to help guide red cell transfusion decisions, in addition to respiratory status and electrolyte balance; and activated clotting time, from GEM Hemochron 100 and Hemochron Signature Elite systems, monitors unfractionated heparin and can help guide reversal.

"Previously, results were viewed on multiple screens or multiple printouts, hand-delivered to the CVOR. Now, GEMweb Live delivers real-time results throughout a cardiac procedure in one glance. This improves efficiency and allows clinicians to make key decisions when time is precious," said Remo Tazzi, Vice President, Worldwide Marketing and Service, Hemostasis and Acute Care Diagnostics at Werfen. "Customer response to GEMweb Live has been extremely positive in the US and Europe, and we look forward to continuing commercialization throughout the world in the months ahead."

Related Links:
Werfen