FDA clears Werfen system to rapidly test for critical bleeding

In situations that can lead to or be made more dangerous by excessive bleeding or clotting—such as heart and liver surgeries, major blood transfusions and severe trauma—it’s crucial that care teams monitor how well a patient’s body is able to prevent and stop bleeding through the biological mechanism known as hemostasis.

Hemostasis is commonly tested using rotational thromboelastometry, or ROTEM. This method monitors a blood sample throughout the clotting process, analyzing its firmness and viscoelasticity both during and after clot formation to assess how well the body can stop itself from bleeding.

A new system from Werfen aims to conduct hemostasis tests at the point of care and return results as rapidly as possible, speeding up the process of identifying and beginning to treat cases of critical bleeding. And with recent clearance from the FDA in its pocket, the ROTEM Sigma thromboelastometry system can now be used by U.S. healthcare providers, with the commercial rollout slated to begin by the end of this year.

The system has already been introduced throughout much of the rest of the world, with clinical usage in Europe, Australia, Asia, Latin America and Africa.

The Sigma system relies on standard “cup-and-pin” thromboelastometry technology, according to Werfen. A blood sample is placed in a cup, with a detection pin suspended in the center. As the cup oscillates, the pin’s movements are recorded; that movement increases as the blood coagulates and begins to adhere more closely to the pin.

The cartridge-based system emits its readings of the sample’s viscoelasticity in real time, allowing clinicians to begin triaging patients at risk of excessive bleeding as quickly as possible—or to prevent unnecessary transfusions. The earliest results of the test begin rolling out within 15 minutes and are all compiled on one screen using Werfen’s GEMweb Live platform.

“Reducing inappropriate transfusions is paramount in healthcare today for patient safety, to help preserve blood supply and for cost containment,” said Remo Tazzi, VP of worldwide marketing and service in Werfen’s hemostasis and acute care diagnostics division. “By viewing real-time, actionable results in the operating room, surgeons, anesthesiologists and other clinicians can make faster and more informed transfusion decisions, improving patient outcomes and enhancing hospital efficiency.”

Werfen kicked off the year with FDA clearance for yet another of its hemostasis testing systems. In that case—which the Barcelona-based medtech maker announced in the first week of January—its GEM Hemochron 100 whole blood hemostasis system was given the go-ahead to begin its U.S. rollout.

That cartridge-based, point-of-care system runs diagnostic tests to calculate activated clotting time, indicating how long it takes for a clot to form, and is typically used to monitor the effects of the anticoagulant drug heparin.