Siemens Healthineers says a new FDA clearance will advance the care of people at risk of heart attacks in the United States.
The German medtech giant announced last week that its Atellica IM high-sensitivity troponin I (TnIH) blood test has secured a new claim extending prognosis up to one year in advance. The test is meant to predict the risk of major cardiac events and death.
According to Siemens Healthineers, Atellica IM is the first test of its kind in the United States to receive FDA clearance for such a one-year prognosis. The company said many U.S. hospitals already use the Atellica IM TnIH blood test to measure people’s cardiac troponin I — a specific and sensitive biomarker that indicates heart muscle injury.
Cardiovascular disease kills an American every 33 seconds and is the leading cause of death in the U.S., according to the Centers for Disease Control and Prevention.
“The new Atellica IM TnIH indication helps us predict which patients may be on the cusp of a major cardiac event,” Dr. Alan H.B. Wu, core lab co-director at Zuckerberg San Francisco General Hospital, said in a news release.
“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.”
Atellica IM could reduce high readmission rates related to cardiac emergency department visits.
Said Michele Zwickl, head of laboratory solutions for diagnostics at Siemens Healthineers North America: “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.”
