VectraCor receives FDA approval for real-time detection of ECG changes suggestive of acute myorcardial infarction

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VectraCor has announced that it has received FDA approval for its VectraplexECG System with VectraplexAMI, a “stand-alone” cardiac monitor/ECG machine with a cardiac electrical biomarker for the real-time detection of ECG changes that may be indicative of an acute myorcardial infarction.

The potential to save more lives with this system is unparalleled as the immediate results allow for potentially faster treatment which protects the heart muscle from further damage, thus improving a patient’s quality of life after a heart attack, the company stated in a press release.

 

“This is an exciting, non-invasive, real-time technology that will benefit many patients and may help clinicians diagnose more quickly the number one 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 acute myorcardial infarction 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 4–6 hours via invasive blood draws. The VectraplexECG System uses only five electrodes to detect ECG changes suggestive of acute myorcardial infarction and derive a 15-lead ECG. This makes placing the electrodes on a patient much easier, more cost-effective and potentially reduces placement error, the company claims.

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