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HemoSonics’ Groundbreaking System for the Management of Critical Bleeding Presented in Four Articles in Anesthesia & Analgesia

Clinical Studies Showed Rapid and Comprehensive Measurement of Coagulation at the Point-of-Care Charlottesville, VA, September 20, 2016 – HemoSonics announced today the publication of four journal articles, accompanied by an editorial, in Anesthesia & Analgesia describing the first clinical experiences with the QuantraTM Hemostasis Analyzer, a groundbreaking system designed to transform and improve the management of critical bleeding. These papers introduce the device and describe the results of multi-center clinical studies involving more than 150 cardiac and spine surgery patients. The leading editorial highlights Quantra’s novel SEER Sonorheometry technology, which may provide significant advantages over existing systems. “The Quantra is a major leap forward in viscoelastic testing, as current hemostasis testing is limited by long result times and incomplete parameter measures,” said Dr. Bruce Spiess, Professor and Associate Chief for Research within the Department of Anesthesiology at the University of Florida and lead author of one of the papers. “These studies demonstrate that the Quantra provides clot time and clot stiffness results that correlate with existing technologies. In addition, the device delivers extremely important information through its Fibrinogen Contribution and Platelet Contribution measures that are not currently available in a rapid time frame. With the Quantra, we have a tool to help rapidly and accurately determine the cause of critical bleeding, enabling precise treatment and reducing unnecessary blood transfusions.” The Quantra and its Surgical Cartridge, the first in a series of test cartridges, were designed to facilitate quick and precise treatment of critical bleeding. These studies demonstrate the ability of the Quantra to monitor coagulation at the point of care in critical care settings and generate comprehensive results in... read more

Introduction to Quantra™ Published in Anesthesia and Analgesia

Charlottesville, VA – June 6, 2016 – HemoSonics today announced that a paper introducing its novel QuantraTM Hemostasis Analyzer was published online in Anesthesia and Analgesia. The paper, A Novel Device for the Evaluation of Hemostatic Function in Critical Care Settings, introduces the Quantra and its initial Surgical Cartridge, which is intended for monitoring coagulation during and after major surgical procedures with potential applications in other critical care settings. The Quantra system was designed to address the market gap for a rapid, comprehensive, easy-to-use, near-patient coagulation analyzer. The paper describes key findings from comparative studies using a research use only (RUO) version of the Quantra System. The Quantra reliably characterized coagulation factor function, and quantified functional fibrinogen, platelet function, and overall clot stiffness as well as the presence of residual heparin anticoagulation. Dysfunctions of these coagulation components are the primary sources of bleeding during and after major surgery. In addition, all Quantra results were obtained within 15 minutes of test initiation, an extremely rapid response for such comprehensive information. The study demonstrated highly reproducible results, with coefficients of variation for each output parameter ranging from 2.5% to 8.8%. In addition, the Quantra displayed a wide dynamic range for measuring clot stiffness, enabling measurement of very soft clots that are often associated with clinical bleeding. Furthermore, Quantra results correlated strongly with existing laboratory tests such as Clauss Fibrinogen. “These findings demonstrate that the Quantra provides a rapid and comprehensive view of a patient’s coagulation status, something currently unavailable today,” said Francesco Viola, Chief Scientific Officer of HemoSonics and lead author on the paper. “These findings suggest that the Quantra and the... read more

Two Abstracts on SEER Technology to be Presented at IARS

Charlottesville, VA – May 19, 2016– HemoSonics today announced two upcoming presentations of data at the International Anesthesia Research Society (IARS) Annual Meeting May 21-24, 2016 in San Francisco, CA demonstrating the clinical utility of the Quantra™ Hemostasis Analyzer in monitoring patients undergoing cardiac and complex spine surgeries. The two studies conducted at the University of Virginia in Charlottesville, VA compared results obtained with research versions of the Quantra, a novel ultrasound-based device that uses Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry to measure the viscoelastic properties of blood, to equivalent rotational thromboelastometery (ROTEM™) and conventional laboratory parameters. The abstract “Comparison of SEER Sonorheometry with Rotational Thromboelastometry and Laboratory Parameters in Cardiac Surgery” authored by Dr. Julie Huffmyer and Dr. Danja Groves showed a strong correlation between Quantra and ROTEM parameters for clot stiffness and fibrinogen contribution in 55 patients undergoing elective cardiac surgery with cardiopulmonary bypass (CPB) (r=0.7-0.9). The Quantra platelet contribution, which reflects both platelet count and function, was well-correlated with the ROTEM platelet parameter but moderately correlated with the laboratory-determined platelet count, underscoring the limits of platelet count and the importance of a comprehensive measure of platelet function in the assessment of coagulation status in CPB patients whose platelet function may be compromised as a result of the procedure and preoperative anti-platelet therapy. Similarly, in the abstract “SEER Sonorheometry versus Rotational Thromboelastometry in Large Volume Blood Loss Spine Surgery”, Dr. Bhiken Naik and co-authors showed a strong correlation between Quantra and ROTEM for determining clot stiffness and assessing fibrinogen and platelet contribution to clot stiffness in 51 patients undergoing multi-level spine surgery. This abstract highlighted... read more

Comparison of SEER Technology to TEG in Cardiac Surgery Published in Anesthesia and Analgesia

Charlottesville, VA – May 10, 2016– HemoSonics today announced that a paper comparing its novel SEER technology to Thromboelastography (TEG) was published online in Anesthesia and Analgesia. The paper, A Comparison of a New Ultrasound-based Whole Blood Viscoelastic Test (SEER Sonorheometry) versus Thromboelastography (TEG) in Cardiac Surgery, describes the results of a study conducted at Virginia Commonwealth University in 50 cardiac surgery patients. The study compared the results of a research version of the Quantra™, a point-of-care in vitro diagnostic platform that measures blood clot formation and breakdown and provides actionable information to aid in the management of critical bleeding and clotting, with the TEG 5000 and standard laboratory tests. The study found that the Quantra results were significantly correlated with TEG measures of clot time (r=0.6-0.7) and clot stiffness (r=0.8-0.9) as well as standard laboratory tests for fibrinogen and platelet count (r=0.6-0.8). Complete Quantra results were available substantially faster than the TEG results (11 minutes vs 42 minutes, averages of Quantra vs TEG respectively), an important distinction in critical care settings where rapid treatment of bleeding is of the essence. The study substantiated the use of the Quantra’s Fibrinogen Contribution parameter, suggesting it may determine a more functional fibrinogen activity as compared to the TEG and conventional laboratory methods. In addition, the study showed a significant correlation between platelet count and the Quantra’s Platelet Contribution measure of platelet function (r=0.6-0.8), a parameter existing viscoelastic technologies do not measure. “Current viscoelastic testing is limited by long result times and incomplete parameter measures,” said Dr. Bruce Spiess, Professor and Associate Chief Anesthesiology (Research) at University of Florida and lead author of... read more


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