TARRYTOWN, N.Y.--(BUSINESS WIRE)--A new prognosis claim for the Siemens Healthineers Atellica IM High-Sensitivity Troponin I (TnIH) test1 immediately advances care for at-risk cardiac patients in the U.S. The easy blood test helps healthcare providers identify patients at risk of death and major cardiac events that could occur up to one year after presenting to the emergency department with signs and symptoms of acute coronary syndrome. It is the first test of its kind in the United States to receive FDA clearance for prognosis.
More than 7 million people present to U.S. EDs annually with a chief complaint of chest pain,2 triggering a cascade of diagnostic efforts to determine if a patient is experiencing a heart attack. The Atellica IM TnIH blood test is used in many hospitals across the country to measure cardiac troponin I in a patient’s blood. Cardiac troponin I is a specific and sensitive biomarker that indicates heart muscle injury.
For the large number of chest pain patients who do not end up with a current heart attack diagnosis, the Siemens Healthineers Atellica IM TnIH test may provide information about their impending risk. As many as 48.9% of patients with an elevated cardiac troponin I result will go on to experience death or a major adverse cardiac event.
“The new Atellica IM TnIH indication helps us predict which patients may be on the cusp of a major cardiac event,” said Dr. Alan H.B. Wu, Core Lab Co-Director, Zuckerberg San Francisco General Hospital. “We learned that nearly 50% of the patients that presented with elevated TnIH results, and a history of cardiac events are at risk for heart attack and/or death. Now this assay, in combination with a robust clinical assessment, can inform physicians on immediate and long-term management of patients to reduce risks for adverse events.”
This information can potentially help reduce high readmission rates associated with cardiac ED visits—30% readmission rates were observed within the first 12 months after initial MI.3 “If just one patient is triaged more effectively because of the clinical information this blood test provides, it could lead to faster intervention, prevent hospital readmission, or even save a life,” said Michele Zwickl, head of laboratory solutions for Diagnostics, Siemens Healthineers North America. It is estimated that up to 12% of patients die within the first year after their heart attack.4
The guideline-acceptable High-Sensitivity Troponin I tests are well-established aids in the diagnosis of heart attack for use on the Atellica Solution, Atellica CI Analyzer, and ADVIA Centaur platforms. With a 10-minute time to first result, the Atellica IM TnIH test now can be used as an aid in prognosis for 30-, 90-, 182-, and 365-day all-cause mortality and major adverse cardiac events (MACE) in patients presenting with signs and symptoms suggestive of acute coronary syndrome (ACS). MACE consists of myocardial infarction, urgent revascularization, cardiac death, or heart failure hospitalization.
The test was first cleared by FDA for in vitro diagnostic use in the quantitative measurement of cardiac troponin I in human serum or plasma (lithium heparin) to aid in the diagnosis of acute myocardial infarction. Since its introduction, the blood test has widely demonstrated its clinical utility in patient care across the globe. The high-sensitivity troponin I blood test offers more precise clinical assessment with highly sensitive detection of AMI in both sexes.5 More information about the Atellica IM TnIH test from Siemens Healthineers is available here.
1 This expanded claim is intended for use in the United States. Claims relevant to use cases in other markets can be found on the Siemens Healthineers website. |
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2 https://www.ahajournals.org/doi/10.1161/HCQ.0000000000000112 |
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3 Dreyer RP, Raparelli V, Tsang SW, D'Onofrio G, Lorenze N, Xie CF, Geda M, Pilote L, Murphy TE. Development and Validation of a Risk Prediction Model for 1-Year Readmission Among Young Adults Hospitalized for Acute Myocardial Infarction. J Am Heart Assoc. 2021 Sep 21;10(18):e021047. doi: 10.1161/JAHA.121.021047. |
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5 Compared to conventional troponin assays. |
Siemens Healthineers pioneers breakthroughs in healthcare. For everyone. Everywhere. Sustainably. The company is a global provider of healthcare equipment, solutions and services, with activities in more than 180 countries and direct representation in more than 70. The group comprises Siemens Healthineers AG, listed as SHL in Frankfurt, Germany, and its subsidiaries. As a leading medical technology company, Siemens Healthineers is committed to improving access to healthcare for underserved communities worldwide and is striving to overcome the most threatening diseases. The company is principally active in the areas of imaging, diagnostics, cancer care and minimally invasive therapies, augmented by digital technology and artificial intelligence. In fiscal 2023, which ended on September 30, 2023, Siemens Healthineers had approximately 71,000 employees worldwide and generated revenue of around €21.7 billion. Further information is available at www.siemens-healthineers.com.
