HemoSonics Registers CE Mark for its New QStat® Cartridge, Expanding the Use of its Innovative Quantra® Hemostasis System to Trauma Surgery and Liver Transplant Settings
Charlottesville, VA – September 10, 2019 – HemoSonics is excited to announce that its new QStat Cartridge, an extension of its groundbreaking Quantra Hemostasis System, has registered for CE Mark and is now commercially available in Europe and Hong Kong. The utility of the Quantra System, which was previously available with the QPlus® Cartridge for cardiovascular and major orthopedic surgeries, is now expanded with the addition of the QStat Cartridge and can now be used across the hospital in trauma surgery and liver transplant settings. The Quantra System provides rapid, actionable coagulation results at the point of care, giving clinicians the opportunity to make informed bleeding management decisions when time is critical.
Improving patient outcomes and facilitating goal-directed therapy is the primary focus of any diagnostic system. But the new Quantra System is breaking new ground in point-of-care viscoelastic testing (VET) efficiency by combining rapid time to results, clear outputs, and a simple intuitive design. SEER (Sonic Estimation of Elasticity via Resonance) Sonorheometry, the revolutionary ultrasound technology, is the foundation of this remarkably efficient and reliable analyzer, which now offers an expanded menu of whole-blood tests in two self-contained cartridges; QPlus for cardiac and major orthopedic surgery, and QStat for trauma and liver transplant surgery.
The QStat Cartridge is a fully sealed, room-temperature stable, disposable cartridge that offers a panel of viscoelastic coagulation tests, including Clot Time (CT), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS), and Clot Stability to Lysis (CSL). All tests except the latter take 25 minutes or less to produce valid results (typically 12-15 minutes), whereas the clot lysis test (CSL) is enabled to run for up to 60 minutes. The Quantra System requires less than 60 seconds of operator’s hands-on time – and requires no pipetting or wait time after draw. Results are provided on an easy-to-read, user-friendly “dials” interface that does not require extensive training.
Studies have demonstrated strong correlation between the Quantra System and both standard laboratory tests and other viscoelastic hemostasis assays. In addition, the QStat Cartridge provides novel parameters designed specifically to give clear actionable information in critical care settings. The Quantra System reports both fibrinogen (FCS) and platelet contributions (PCS) to clot stiffness, giving clinicians the opportunity to quickly consider the most appropriate therapies to apply when bleeding is a concern. The Clot Stability to Lysis (CSL) test provides an adaptive and confirmatory result based on the level and onset time of clot lysis. Additionally, the Quantra QStat System directly analyzes and compares changes in clot stiffness in both the presence and absence of tranexamic acid, thus automatically correcting for potentially confounding results inherent to earlier VET systems.
“Trauma and liver surgeries pose an enormous risk of acute bleeding,” said Timothy J. Fischer, President and Chief Executive Officer of HemoSonics. “The Quantra QStat System is a breakthrough in point-of-care bleeding management because it provides rapid, reliable, and novel information to aid clinicians in their decision making in the ER, trauma bay, or post-operative ICU. What makes the new QStat Cartridge unique is its unparalleled ease of use and its innovative coagulation tests for critical injury and liver transplant, including Platelet Contribution to Clot Stiffness and Clot Stability to Lysis.”
The Quantra Hemostasis System, including QPlus and QStat Cartridges and 2 levels of external quality controls, is commercially available in countries within Europe.
In the United States, the Quantra Hemostasis Analyzer, QPlus Cartridge and associated external quality controls comprise the Quantra® QPlus® System which received de novo marketing authorization by the FDA in March of 2019. In the United States the QStat Cartridge is available for investigational use only.
HemoSonics is a medical device company with the primary mission to deliver clinical tools that provide actionable information in the critical care settings; resulting in better care for patients and lower overall medical costs.
The Quantra Hemostasis Analyzer, the flagship product of HemoSonics, is designed to improve patient outcomes and reduce healthcare costs by providing unique and optimized coagulation information, for easy and fast interpretation and simple, more efficient point-of-care bleeding management workflows.
HemoSonics is headquartered in Charlottesville, VA, with research, development and manufacturing facilities in Durham, NC. For more information, visit www.hemosonics.com.
HemoSonics is part of the Stago group, a leading company in the in vitro Diagnostics industry dedicated to the exploration of thrombosis and hemostasis.