Business Wire

HemoSonics Registers CE Mark for its New QStat® Cartridge, Expanding the Use of its Innovative Quantra® Hemostasis System to Trauma Surgery and Liver Transplant Settings

Share

HemoSonics is excited to announce that its new QStat Cartridge, an extension of its groundbreaking Quantra Hemostasis System, has registered for CE Mark and is now commercially available in Europe and Hong Kong. The utility of the Quantra System, which was previously available with the QPlus Cartridge for cardiovascular and major orthopedic surgeries, is now expanded with the addition of the QStat Cartridge and can now be used across the hospital in trauma surgery and liver transplant settings. The Quantra System provides rapid, actionable coagulation results at the point of care, giving clinicians the opportunity to make informed bleeding management decisions when time is critical.

Improving patient outcomes and facilitating goal-directed therapy is the primary focus of any diagnostic system. But the new Quantra System is breaking new ground in point-of-care viscoelastic testing (VET) efficiency by combining rapid time to results, clear outputs, and a simple intuitive design. SEER (Sonic Estimation of Elasticity via Resonance) Sonorheometry, the revolutionary ultrasound technology, is the foundation of this remarkably efficient and reliable analyzer, which now offers an expanded menu of whole-blood tests in two self-contained cartridges; QPlus® for cardiac and major orthopedic surgery, and QStat for trauma and liver transplant surgery.

The QStat Cartridge is a fully sealed, room-temperature stable, disposable cartridge that offers a panel of viscoelastic coagulation tests, including Clot Time (CT), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS), and Clot Stability to Lysis (CSL). All tests except the latter take 25 minutes or less to produce valid results (typically 12-15 minutes), whereas the clot lysis test (CSL) is enabled to run for up to 60 minutes. The Quantra System requires less than 60 seconds of operator’s hands-on time – and requires no pipetting or wait time after draw. Results are provided on an easy-to-read, user-friendly “dials” interface that does not require extensive training.

Studies have demonstrated strong correlation between the Quantra System and both standard laboratory tests and other viscoelastic hemostasis assays. In addition, the QStat Cartridge provides novel parameters designed specifically to give clear actionable information in critical care settings. The Quantra System reports both fibrinogen (FCS) and platelet contributions (PCS) to clot stiffness, giving clinicians the opportunity to quickly consider the most appropriate therapies to apply when bleeding is a concern. The Clot Stability to Lysis (CSL) test provides an adaptive and confirmatory result based on the level and onset time of clot lysis. Additionally, the Quantra QStat System directly analyzes and compares changes in clot stiffness in both the presence and absence of tranexamic acid, thus automatically correcting for potentially confounding results inherent to earlier VET systems.

“Trauma and liver surgeries pose an enormous risk of acute bleeding,” said Timothy J. Fischer, President and Chief Executive Officer of HemoSonics. “The Quantra QStat System is a breakthrough in point-of-care bleeding management because it provides rapid, reliable, and novel information to aid clinicians in their decision making in the ER, trauma bay, or post-operative ICU. What makes the new QStat Cartridge unique is its unparalleled ease of use and its innovative coagulation tests for critical injury and liver transplant, including Platelet Contribution to Clot Stiffness and Clot Stability to Lysis.”

Availability
The Quantra Hemostasis System, including QPlus and QStat Cartridges and 2 levels of external quality controls, is commercially available in countries within Europe.

In the United States, the Quantra Hemostasis Analyzer, QPlus Cartridge and associated external quality controls comprise the Quantra® QPlus® System which received de novo marketing authorization by the FDA in March of 2019. In the United States the QStat Cartridge is available for investigational use only.

About HemoSonics
HemoSonics is a medical device company with the primary mission to deliver clinical tools that provide actionable information in the critical care settings; resulting in better care for patients and lower overall medical costs.

The Quantra Hemostasis Analyzer, the flagship product of HemoSonics, is designed to improve patient outcomes and reduce healthcare costs by providing unique and optimized coagulation information, for easy and fast interpretation and simple, more efficient point-of-care bleeding management workflows.

HemoSonics is headquartered in Charlottesville, VA, with research, development and manufacturing facilities in Durham, NC. For more information, visit www.hemosonics.com.

HemoSonics is part of the Stago group, a leading company in the in vitro Diagnostics industry dedicated to the exploration of thrombosis and hemostasis.

Contact information

Lee DeGeer
Chief Commercial Officer
(919) 504-1030
contact@hemosonics.com
HemoSonics.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Velodyne Shows Velarray Lidar in Sleek Car Designs at IAA 2019 Conference14.9.2019 19:39:00 CESTPress release

Velodyne Lidar, Inc. (Hall 8.0, Booth A13) is showcasing the pristine integration of Velarray lidar sensors into consumer vehicles to make currently available, high-end electric vehicles safer at the IAA 2019 Conference. Velodyne has addressed the market need for lidar technology that enables high-level Advanced Driver Assistance Systems (ADAS) for safe navigation and collision avoidance, all within a compact form factor. The lidar is situated behind the vehicle’s windshield for streamlined, flawless integration. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190914005023/en/ Can you see the lidar? The Velarray is embedded in a sleek electric car at IAA 2019 (Hall 8.0, Booth A13). (Photo: Velodyne Lidar) Velodyne booth visitors can see how the Velodyne Velarray™ sensors are beautifully integrated into sleek, high-end vehicles, maintaining their aerodynamic design. The Velarray’s small, embeddable form factor is a powerful so

Insurance Leaders and Visa Digitize Claims Payouts for Individuals and Businesses When They Need It Most13.9.2019 14:37:00 CESTPress release

Emergencies like car collisions or natural disasters come when people least expect them, leaving individuals unprepared to complete insurance forms, confirm claim estimates, and pay repair shop and medical expenses. During these times, quick access to funds is critical. Visa is committed to working with innovative companies in the insurance industry to help turn outdated and time-consuming processes associated with insurance claim payouts into near real-time1 access to payments when individuals, families and businesses need them the most. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190913005323/en/ Visa Direct powers real-time insurance payouts, providing people access to their funds when they need it most. (Graphic: Business Wire) “Visa believes that money shouldn’t be a stressor in moments of crisis and waiting on average six to 10 days to access the money from insurance checks, is outdated, frustrating and costly to th

Wipro Positioned as a Leader in the IDC MarketScape for Utilities Customer Experience, Worldwide13.9.2019 12:55:00 CESTPress release

Wipro Limited (NYSE: WIT) (BSE: 507685) (NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced that it has been positioned as a leader in the IDC MarketScape: Worldwide Professional Services Firms for Utilities Customer Experience 2019 Vendor Assessment (doc #US42713318, July 2019). Wipro has been recognised for key strengths including provider of fast as-a-service implementations of IT systems, for Utilities and cost-effective quality of service delivery models. The study evaluated the Utilities Customer Experience (CX) transformation and digital capabilities of 15 service providers and mapped them based on strategies, capability and market impact related parameters. Key Highlights include- The report notes Wipro’s internal program aimed at comprehensively addressing the challenges faced by utilities. Selected employees are assigned to one of six "domain tribes" — customer services, network operations, new energy servic

Jefferies to Hold Global Relief Day in Support of Hurricane Relief in the Bahamas, Monday, September 1613.9.2019 12:00:00 CESTPress release

Jefferies confirmed that the firm’s global trading day for Hurricane Dorian relief efforts in the Bahamas will be held on Monday, September 16. Jefferies will offer investors around the world the opportunity to join efforts to assist those affected by the devastation of this event by trading with Jefferies. As previously announced, Jefferies will donate all net trading commissions on Monday, September 16, from U.S., European and Asia equity, fixed income and foreign exchange trading. In addition, Jefferies will donate an additional $1 million itself, and all 3,656 employees worldwide will be given the opportunity to personally donate to the relief effort. These contributions will be allocated to a series of charities with the goal of quickly getting funds to relief efforts directly involved in the rescue and recovery efforts. Rich Handler, Chairman and Chief Executive Officer of Jefferies, and Brian Friedman, Chairman of the Executive Committee, commented: "All of us at Jefferies are d

 Knopp Biosciences to Present Data Characterizing Its Kv7 Technology Platform’s Potential for Delivering Precision Medicines to Treat Diverse Neurological and Smooth Muscle Diseases13.9.2019 10:00:00 CESTPress release

Knopp Biosciences LLC today reports data demonstrating that compound subgroups from its proprietary library of potassium-channel modulators selectively target Kv7 channel subtypes associated with a wide range of neurological and smooth muscle diseases. The data is being presented at the International Kv7 Channels Symposium 2019 in Naples, Italy. Presentation Title: The Re-emergence of Kv7 Drug Discovery Presenter: Michael Bozik, M.D., CEO, Knopp Biosciences Date & Time: September 13, 4:35 pm CEST Michael Bozik, M.D., Chief Executive Officer of Knopp, will present the data derived from the Company’s proprietary library of more than 3,000 novel compounds directed to modulating the Kv7 channel, which regulates the flow of potassium ions across cell membranes. The data demonstrate that specific subgroups of Kv7 compounds selectively modulate different Kv7 channel subtypes across ranges of channel activation and inhibition, enabling selection of compounds capable of targeting neurological d

PenSam Selects Moody’s Analytics Economic Scenario Generator to Support New Risk Modeling Framework13.9.2019 09:00:00 CESTPress release

Moody’s Analytics, a global provider of financial intelligence, announced today that its software has been selected by PenSam, one of Denmark’s leading labor market pension and insurance firms. PenSam will be using the Moody’s Analytics Economic Scenario Generator (ESG) for actuarial liability valuations, risk management, strategic asset allocation, and asset and liability management (ALM). The Moody’s Analytics ESG is an award-winning simulation framework which clients deploy in areas such as actuarial reporting, risk and capital calculation and analysis, and investment and ALM analysis. PenSam will also take advantage of the Moody’s Analytics Automation Module, which allows insurers to streamline their modeling processes by automating model set-up, execution, and validation, in turn reducing production time and cost. “The Danish pensions and insurance market is going through a period of change, with insurance companies across the country reassessing their risk management frameworks a