The FDA has granted a de novo clearance to HemoSonics’ point-of-care diagnostic for determining a patient’s coagulation status within 15 minutes, enabling it to respond to critical bleeding situations in the operating room and intensive care.
Previous hemostatic testing methods may take too long to be useful in such moments, leading clinicians to deliver transfusions regardless of how well patients are coagulating on their own.
The company estimates that as many as 60% of red blood cell transfusions may not be needed, or that doctors may give transfusions of inappropriate types of products such as fresh plasma versus clotting factor concentrates, platelet transfusions or other agents.
The tests are also important in screening for patients with hemostatic defects, which could lead to excessive bleeding during a surgical procedure.
HemoSonics’ cartridge-based Quantra analyzer uses ultrasound waves to measure the viscosity of a whole blood sample in a fully closed system designed for busy perioperative settings. As the blood coagulates over time within the device, its stiffness increases, which can be read by the ultrasound in a fully automated, set-it-and-forget-it procedure.
The system can also assess platelet contribution to clot stiffness, as well as the likelihood of residual heparin blood thinner in the sample. The Quantra Hemostasis Analyzer and its QPlus cartridge are now available for sale in the U.S. as well as in Europe, the company said.
“Critical bleeding occurs frequently in cardiac and major orthopedic surgeries,” HemoSonics President and CEO Timothy Fischer said in a statement. “Faster results can mean better management of critical bleeding, more cost-effective treatment, and ultimately better outcomes for patients.”