FDA OKs Werfen’s GEM Hemochron 100 Hemostasis System

Werfen received 510(k) clearance for the GEM Hemochron 100 whole blood hemostasis system by the U.S. Food and Drug Administration (FDA). Leveraging Hemochron technology, the GEM Hemochron 100 system, delivers fast, actionable activated clotting time (ACT) results in minutes, informing patient-management decisions and helping improve workflow at the point of care (POC). The GEM Hemochron 100 system is currently in clinical use in several European countries and will be commercialized in the U.S. in early 2022.
 
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.
 
“In critical procedures, such as cardiac surgery, accuracy, speed and reliability of whole blood hemostasis testing to guide heparin therapy is paramount—and the GEM Hemochron 100 delivers,” said Remo Tazzi, VP, Worldwide Marketing and Service, Hemostasis and Acute Care Diagnostics, at Werfen. “This allows clinicians to make informed patient management decisions at the point of care, helping improve patient outcomes in the Cardiovascular Operating Room and other acute care settings.” 
 
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. 
 
Supporting current clinical practice guidelines, GEM Hemochron 100 ACT tests provide a maximally activated clotting time. This enables a shorter testing time, reduces susceptibility to hypothermia and artifacts, removes variability induced by hemodilution and correlates more closely to factor Xa activity, when compared to tests using a single activator.¹
 
New integrated Wi-Fi capabilities in the GEM Hemochron 100 enable wireless, automatic, bidirectional data transmission and remote configuration. The GEM Hemochron 100 also offers an encrypted connection to ensure the security of patient data. GEMweb Plus 500 Custom Connectivity simplifies and centralizes remote management of POC operators and GEM Hemochron 100 systems, as well as other Werfen and non-Werfen analyzers, throughout a hospital or hospital network.
 
Reference
¹ Shore-Lesserson L, Baker RA, Ferraris VA, Greilich PE, Fitzgerald D, Roman P, Hammon JW. The Society of Thoracic Surgeons, The Society of Cardiovascular Anesthesiologists, and The American Society of ExtraCorporeal Technology: Clinical Practice Guidelines—Anticoagulation During Cardiopulmonary Bypass. Ann Thorac Surg: 2018;105:650-662.