ROTEM receives FDA clearance for new hemostasis analyzer

Surgical teams now can get faster and more complete information on the status of their patients' coagulation state from the ROTEM® hemostasis analyzer, recently cleared by the Food and Drug Administration (FDA). The ROTEM delta analyzer has been used in more than 50 countries since 2003 and the reliable instrument and five assays (in-tem®, ex-tem®, hep-tem®, fib-tem® and ap-tem® are now available for clinicians in the U.S. This proven technology provides key information in just 5-10 minutes to guide cardiovascular, trauma and liver transplant procedures.

"Having quick, accurate information in surgery is critical to providing the best patient outcomes," says Ken West, president of ROTEM. "With the new ROTEM system, surgeons don't have to wait for traditional laboratory tests which can take 30 minutes or more. They can now get more complete hemostasis information quicker and use this information to help decide whether there is a need for a transfusion and which blood products to transfuse."

The ROTEM delta hemostasis analyzer system provides in-depth information on hemostasis beyond the routine testing that is currently done during surgery. ROTEM testing is performed on whole blood samples and provides information on the complex biological process of coagulation. Results are provided rapidly to the OR on a variety of coagulation parameters, helping the surgical team to decide whether platelets, plasma, red blood cells or other blood components are in proper balance or need to be augmented by transfusion.

With more complete reporting at surgeons' disposal, patient outcomes improve and hospital expenses decrease by saving on the cost of blood products. A better understanding of patients' hemostasis means fewer unnecessary blood transfusions, and a lower risk of infection or complications associated with those transfusions. The value of the ROTEM system has been demonstrated in more than 500 publications by clinical leaders, and over 1,600 systems are in use around the world.

"With the latest FDA clearance, we can offer the full ROTEM technology to hospitals, blood banks and research centers, and we provide thorough training and support from our headquarters in the Research Triangle Park area," says West.