HemoSonics, a medical device company developing a next-generation hemostasis analyzer for use in hospital point-of-care environments, announced favorable results in multi-site studies of its Quantra Hemostasis Analyzer, a system designed to transform and improve the management of critical bleeding.
The results, involving more than 150 cardiac and spine surgery patients and published in a series of articles in Anesthesia & Analgesia, show that Quantra delivered complete coagulation results in less than 15 minutes, which is vital in critical bleeding situations, according to the company.
“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 Corp.) 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 an 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]
The Quantra Hemostasis Analyzer is currently for investigational use only. The performance characteristics of the product have not been established. HemoSonics has initiated its next round of clinical trials on the Quantra platform and expects to submit a direct de novo petition to the FDA for clearance of the device in 2017.
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 Quantra Hemostasis Analyzer is designed to provide comprehensive, timely information on coagulation status at the point of care. HemoSonics is headquartered in Charlottesville, VA, with research, development and manufacturing facilities in Durham, NC. www.hemosonics.com.