Current hemostatic tests provide only a subset of needed information, or take too long to be useful in critical bleeding situations, forcing clinicians to use iterative transfusion protocols that do not account for the patient’s actual coagulation status. This approach leads to over-transfusion and transfusion of inappropriate products. Up to 60% of red blood cell (RBC) transfusions lack clinical justification. Further, blood products are costly, making up about 1-2% of a hospital’s budget. Hospitals around the world are thus seeking ways to reduce their transfusion rates to improve outcomes and reduce costs.

Now, a next-generation point-of-care (POC) hemostasis system leverages innovative medical-grade ultrasound technology to measure the coagulation properties of a whole blood sample. The system enables clinicians to deliver patient-centered coagulation therapy that improves care and optimizes blood product usage. With its rapid results, ease of operation, and dials screen for straightforward interpretation, it is the only whole blood hemostasis testing system specifically cleared for use in POC settings, such as operating rooms, emergency departments, and intensive care units.

HemoSonics, LLC’s (Durham, NC, USA) innovative Quantra hemostasis analyzer platform, based on patented SEER sonorheometry, enables fully automated, rapid point-of-care viscoelastic testing and gives physicians the results they need at the POC to make more informed decisions. SEER uses state-of-the-art ultrasound technology to measure clot stiffness (shear modulus of elasticity) over time using ultrasound-induced resonance. The Quantra system’s innovative closed-cartridge design requires no open-tube blood manipulation after sample collection and it automatically runs internal QC every eight hours and with every test. The Quantra system’s innovative ultrasound technology, proprietary closed-cartridge design, unparalleled ease of use, and ease of interpretation make it uniquely suited for use in critical or emergency care settings.

HemoSonics has now received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. The FDA clearance of the QStat Cartridge expands the Quantra System's indications for use to include trauma, and liver transplantation procedures. The QStat Cartridge assay, in addition to the System's already established QPlus Cartridge assay, increases Quantra's overall diagnostic capabilities to now cover the broadest range of clinical indications of any point-of-care hemostasis analyzer available in the U.S. market today.

"The Quantra Hemostasis System with QStat Cartridge is breaking new ground and leading innovation in the point-of-care and laboratory-based whole blood hemostasis testing market. Today's clearance significantly expands the clinical indications of the Quantra System, creating the greatest opportunity to address the critical unmet clinical needs of our healthcare provider partners and the patients that we serve," said Robert Roda, President, and Chief Executive Officer of HemoSonics.

"Point-of-care data is the answer to PBM-guided patient decisions. It is a triple win; Patients get improved outcomes, public health is improved, and cost savings are achieved," said Dr. Bruce Spiess, Medical Director of HemoSonics. "The Quantra Hemostasis System with QStat and QPlus Cartridges will assist more clinicians in determining which specific blood products are needed to rapidly treat individual patients. It has the potential to positively impact patient outcomes for hundreds of thousands of trauma patients and thousands of liver transplant recipients each year by optimizing blood product usage and conserving critically low blood supplies." 

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