FDA Grants HemoSonics Expanded Use of its Critical Bleeding Management System with Special 510(k) Clearance

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Apr 03, 2024, 08:10 ET

HemoSonics' Quantra® Hemostasis Analyzer provides comprehensive blood analysis that details critical bleeding disorders and helps clinicians manage patients back into hemostasis. The Quantra System has the broadest range of FDA-cleared indications for use in its category and is cleared for use with arterial and venous blood samples in cardiac, trauma, liver, and major orthopedic surgery patients.

DURHAM, N.C., April 3, 2024 /PRNewswire/ -- HemoSonics, a medical device company focused on acute bleeding management, today announced it has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded use of arterial blood samples with its Quantra QStat® Cartridge. HemoSonics' QStat Cartridge used with the Quantra Hemostasis Analyzer first received 510(k) clearance from the U.S. FDA in 2022 for use in venous whole blood samples. Today's announcement enables hospitals to further standardize and operationalize viscoelastic testing with an arterial and venous indication for both HemoSonics' QStat Cartridge and the QPlus® Cartridge.

The Quantra Hemostasis System with QStat Cartridge.

"The FDA 510(k) clearance for arterial blood sample use with our QStat Cartridge will make it easier and more convenient for hospitals to use the Quantra System," said Bob Roda, President and CEO of HemoSonics. "The Quantra System now has the broadest range of FDA-cleared clinical indications of any cartridge-based viscoelastic testing system. It is cleared for use in cardiac, trauma, liver, and major orthopedic surgeries. We will continue to innovate in our mission to help patients and hospitals preserve blood, which is a precious resource."

HemoSonics' Quantra Hemostasis System consists of the Quantra Hemostasis Analyzer with QPlus and QStat Cartridges, which enable clinicians to deliver patient-centered decisions on bleeding management that improve care and optimize blood product usage. The Quantra System is FDA-cleared for use in point-of-care settings such as operating rooms, intensive care units, and in hospital laboratories, enabling hospitals to standardize use institution-wide with greater operational efficiency.

The Quantra System allows healthcare professionals to make individualized and evidence-based decisions on how to manage a bleeding patient and give a patient only medically appropriate therapy – an approach that supports global initiatives to reduce inappropriate transfusions of blood products. The Quantra System requires minimal resources to maintain, is easy to operate and interpret, and provides fast, comprehensive whole-blood coagulation analysis at the point of care or in laboratory-based settings, typically in less than 15 minutes.

The American Red Cross declared a blood shortage emergency in January 2024, and preserving blood is more important for medical care facilities and their communities than ever. Additionally, blood acquisition remains the most significant expense for hospital blood banks. HemoSonics' Quantra technology helps patients and hospitals by preserving precious blood supplies: a 2023 Journal of Cardiothoracic Surgery study showed that implementation of the Quantra Hemostasis Analyzer with the QPlus Cartridge reduced utilization of blood components by up to 90%, allowing greater availability for those patients truly in need. In addition, the cost of blood products decreased by 41%.

Email [email protected] or visit https://hemosonics.com to learn more.

About HemoSonics
HemoSonics, LLC is a medical device technology company focused on acute bleeding management, resulting in better patient care and lower overall medical costs. The Quantra Hemostasis Analyzer, HemoSonics' flagship product, is designed to improve patient outcomes and reduce healthcare costs by providing optimized coagulation information. The Quantra System's easy and fast interpretation enables simple, more efficient point-of-care and laboratory bleeding management. Based in Durham, NC, HemoSonics is part of the Stago Group, a leading in vitro diagnostics company dedicated to exploring thrombosis and hemostasis. Visit HemoSonics.com to learn more.

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SOURCE HEMOSONICS LLC