Siemens Receives FDA Clearance For Its Innovance D-Dimer Test To Exclude Deep Vein Thrombosis

Main Category: Vascular
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 25 Jan 2011 - 3:00 PDT


Siemens Healthcare Diagnostics INNOVANCE® D-Dimer blood test has been cleared by the FDA to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients where a physicians pretest probability assessment (PTP) indicates a non-high probability of embolism. The expanded use of this test helps physicians provide more timely patient diagnosis in high-risk and emergency care situations.

DVT and PE are serious medical conditions, affecting millions of people worldwide every year. Last July, medical examiners ruled that DVT and PE caused a woman's death on a recent transatlantic flight1, and they have also been linked to the widely-reported death of NBC correspondent David Bloom in Iraq in 20032. DVT is caused by the formation of a blood clot in the deep veins of the legs, pelvis or upper extremities, leading to either partially or fully blocked circulation. PE occurs when a clot breaks loose and travels to pulmonary arteries. Both conditions can cause death if they are not diagnosed and treated properly3.

Siemens fully automated D-dimer blood test, performed on the company's Sysmex® and BCS® family of coagulation systems, benefits clinical laboratories of all types and sizes and can be used in both routine and emergency care settings.

In addition to the D-dimer blood test, Siemens offers ultrasound imaging to detect and monitor DVT, providing physicians with the benefit of a fast, non-invasive method for evaluation, either as an initial or follow-up examination. The company also maintains a complete portfolio of computed tomography scanners, the standard imaging modality for the detection and follow-up of PE.

"Siemens offers more options now to evaluate and monitor possible blood clots in patients to help physicians quickly initiate proper treatment if needed," said Michael Noeh, Vice President, Global Marketing Hemostasis & Hematology, Siemens Healthcare Diagnostics. "It's especially important we offer physicians options for use in high-risk or emergency situations, to help save lives and reduce costs related to unnecessary testing and treatment."

1. See here.

2. See here.

3. Department of Health and Human Services, Center for Disease Control and Prevention; Deep Vein Thrombosis Topics. Available here. Accessed July 28, 2010.

Source:
Siemens Healthcare Sector

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