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Press Release

FDA Clears Full Array of ROTEM® Assays for New Hemostasis Analyzer

RESEARCH TRIANGLE PARK, N.C. (August 16, 2011) ­ Surgical teams now can get faster and more complete information about their patients' coagulation status from the ROTEM® hemostasis analyzer, recently cleared by the U.S. Food and Drug Administration (FDA). The ROTEM® analyzer has been used in more than 50 countries since it was first introduced in 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 technology provides key coagulation information in 5-10 minutes for patients undergoing cardiovascular, trauma and liver transplant procedures. The value of the ROTEM® system has been demonstrated in more than 500 publications by clinical leaders and more than 1,600 systems are in use around the world.

"Having quick, accurate information in surgery is critical to providing the best patient outcomes," says Ken West, president of Tem Systems, Inc. "With the new ROTEM® system, surgeons don't have to wait for traditional laboratory coagulation tests which can take 30 minutes or more."

Faster and more complete hemostasis information can help the surgical team decide whether there is a need for a transfusion and which blood products to transfuse. In addition, with more detailed hemostasis information at surgeons' disposal, patient outcomes have been shown to improve and hospital expenses related to blood products decrease. A better understanding of patients' hemostasis also can lead to fewer unnecessary blood transfusions, and a lower risk of infection or complications associated with those transfusions. The ROTEM® delta hemostasis analyzer system provides in-depth information on all stages of hemostasis, which goes 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 assess whether platelets, plasma, red blood cells or other blood components are in proper balance.

"Unlike other clotting assays, our rotational thromboelastometry technology analyzes whole blood and provides information about all stages of the coagulation process," says West. "With the latest FDA clearance, we can offer the full ROTEM® technology to U.S. hospitals, blood banks and research centers, and we provide thorough training and support from our headquarters in Research Triangle Park, NC." The ROTEM® system will be exhibited and demonstrated at these upcoming meetings:

· AmSECT's New Advances in Blood Management in Seattle · American Association for Surgery of Trauma in Chicago (AAST) · Society for Advancement of Blood Management in Philadelphia (SABM) · American Society for Anesthesiology in Chicago (ASA) · American Association for Blood Banking in San Diego (AABB)

To learn more about the ROTEM® delta hemostasis analyzer system or to schedule a demonstration, contact Tem Systems, Inc. at 919-941-7777 or visit

About TEM Systems, Inc. ROTEM® is marketed by Tem Systems, Inc., the US subsidiary of Tem Innovations GmbH, the developer and manufacturer of the ROTEM® hemostasis analyzer. The ROTEM® analyzer provides a surgical team with rapid and more complete information on a patient's hemostasis condition. Since its introduction in 2003, more than 1,600 ROTEM® analyzers have been placed into clinical use in more than 50 countries around the world.

Further information: Ken West, President Tem Systems Inc. 4309 Emperor Blvd., Suite 100 Durham NC 27703 Phone: 919-941-7777, x108, Fax: 919-941-1056 [email protected]


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