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 less than 15 minutes.
In the studies performed at the University of Virginia (Charlottesville, VA) and Virginia Commonwealth University (Richmond, VA), test results obtained with research versions of the Quantra were compared with similar parameters measured by the TEG® 5000 (Haemonetics Corporation) and the ROTEM® Delta (TEM Systems, Inc.). Study results showed strong correlation between the Quantra parameters for clot stiffness and the corresponding TEG and ROTEM parameters. The publications further highlight that the Quantra represents a clinically viable solution for the rapid and accurate measurement of fibrinogen from whole blood and that, unique to this platform, the Quantra can provide a direct measurement of platelet contribution to clot stiffness, a more clinically relevant measurement than platelet count.
“During major surgery and organ transplantation, clinicians need fast, accurate, and actionable data on hemostasis to properly manage and treat critical bleeding,” said Timothy Fischer, President and Chief Executive Officer of HemoSonics. “These comprehensive results will allow clinicians to quickly address bleeding, improve health outcomes and ultimately reduce healthcare costs by enabling more targeted transfusion of blood products. The editorial supports the potential advantages of SEER Sonorheometry as a more sensitive measure of clot stiffness, which is consistent with our published data.”
The four journal articles and the accompanying editorial are available online and are expected to be published in the December edition of Anesthesia & Analgesia:
- A Novel Device for the Evaluation of Hemostatic Function in Critical Care Settings
- A Comparison of a New Ultrasound-Based Whole Blood Viscoelastic Test (SEER Sonorheometry) Versus Thromboelastography in Cardiac Surgery
- SEER Sonorheometry Versus Rotational Thromboelastometry in Large Volume Blood Loss Spine Surgery
- Comparison of SEER Sonorheometry with Rotational Thromboelastometry and Laboratory Parameters in Cardiac Surgery [Not yet available online]
- SEER Sonorheometry: Listening to What the Clot Has to Say
HemoSonics is a medical device company developing a point-of-care diagnostic platform to guide the management of critical bleeding to improve outcomes and reduce healthcare costs by enabling more targeted transfusion of blood products. The QuantraTM Hemostasis Analyzer is designed to transform the way clinicians manage coagulation dysfunctions by providing comprehensive, timely information on coagulation status at the point of care. The Quantra is designed to deliver easy-to-understand comprehensive measures of the treatable aspects of coagulation in just 15 minutes at the point of care in the operating room, intensive care unit and other critical-care settings. HemoSonics is headquartered in Charlottesville, VA, with research, development and manufacturing facilities in Durham, NC. For more information, visit hemosonics.com.
The Quantra Hemostasis Analyzer is currently for investigational use only. The performance characteristics of this product have not been established.