FDA has recently granted de novo 510(k) marketing authorization for the Quantra hemostasis analyzer platform and its initial QPlus cartridge by HemoSonics, Charlottesville, Va. The analyzer and cartridge are now available for sale in the United States.
The fast and easy-to-use Quantra QPlus system provides clinicians with novel and actionable information about a patient’s coagulation status at the point of care. With hands-on time of less than a minute, the Quantra QPlus system leverages ultrasound technology to provide rapid viscoelastic results in 15 minutes or less, using a simple workflow and intuitive interface. When time is most critical, Quantra’s rapid, precise, and easy-to-read results may enable clinicians to make informed decisions more quickly.
“The Quantra hemostasis analyzer is revolutionary and a dramatic improvement over existing tools,” says Danja Groves, MD, an associate professor of anesthesiology at the University of Virginia Medical Center. “Using the Quantra, clinicians have information that was previously unavailable, in a time frame that enables proactive bleeding management. This is a game-changer for transfusion management.”
The Quantra QPlus system utilizes a fully sealed consumable cartridge to run a panel of viscoelastic blood coagulation tests. The company’s patented sonic estimation of elasticity via resonance (SEER) sonorheometry ultrasound technology provides fully automated testing in a closed system, enabling point-of-care use in busy clinical environments.
Studies have demonstrated a strong correlation between Quantra results, standard laboratory test results, and the results of other viscoelastic hemostasis assays. The Quantra system also introduces unique parameters that assess platelet contribution to clot stiffness and the likelihood of residual heparin in a patient’s sample. These features are only available in the United States on the company’s Quantra QPlus system.
“Critical bleeding occurs frequently in cardiac and major orthopedic surgeries,” explains Timothy Fischer, president and CEO of HemoSonics. “The Quantra QPlus system revolutionizes point-of-care management by delivering accurate and novel results in a fraction of the time required previously, near the OR, surgical suite, or ICU. Faster results can mean better management of critical bleeding, more cost-effective treatment, and ultimately better outcomes for patients.”
For further information, visit HemoSonics.