VectraCor Receives FDA Approval for Real-Time Detection of ECG Changes Suggestive of AMI


March 29, 2012

March 29, 2012 — VectraCor Inc. announced at the American College of Cardiology’s 61st Annual Scientific Session (ACC) in Chicago that it received U.S. Food and Drug Administration (FDA) approval for the VectraplexECG System with VectraplexAMI. It is a stand-alone cardiac monitor/electrocardiography (ECG) machine with a cardiac electric biomarker (CEB) for real-time detection of ECG changes that may be indicative of an acute myocardial infarction (AMI) plus the capability to derive a 15-lead ECG.

"This is an exciting, non-invasive, real-time technology that will benefit many patients and may help clinicians diagnose more quickly the No. 1 disease in the world, which potentially can become the new standard-of-care in cardiac monitoring," said Brad S. Schreck, president and CEO of VectraCor.

The current gold standard for AMI detection is a long process which can continue up to 24 hours and involves placing 10 electrodes to produce a 12-lead ECG and measure serum biomarkers every four to six hours via invasive blood draws. The VectraplexECG System uses only five electrodes to detect ECG changes suggestive of AMI and derive a 15-lead ECG. This makes placing the electrodes on a patient much easier, more cost-effective and potentially reduces placement error.

VectraCor plans to incorporate the technology into other devices such as stress test systems and mobile ambulatory Holters/event monitors that will allow real-time monitoring between doctor and patient via the Verizon Wireless Network.

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