Wednesday, September 19, 2012 12:19 PM
December, 2011 – VectraCor receives CE Mark Registration for VectraplexECG System with VectraplexAMI. The VectraplexECG System with VectraplexAMI will produce visual and audible alarms for ECG changes that, in the appropriate clinical settings, may be indicative of acute myocardial infarction (heart attack) in real time, non-invasively. In addition, VectraCor’s technology can derive 12-22 lead (standard 12 lead, right heart leads V3R-V6R, posterior leads V7-V9, and vectorcardiogram XYZ leads with Vector Loops) electrocardiogram (ECG) with only 3 leads (5 electrodes) connected to the patient.
November, 2011 – VectraCor receives FDA Approval for VectraplexECG System with VectraplexAMI. The system in real time detects ECG changes that may be indicative of an Acute Myocardial Infarction and displays/prints a 15 lead ECG (12 lead ECG, XYZ leads and Vector Loops) for the US market.
VectraCor, Inc. is a medical device company developing “Disruptive Early Detection Technology” in the Cardiology marketplace with worldwide patents granted and over 40 published papers or abstracts.
The current standard of care for any patient entering any acute care setting, such as an emergency department, with a potential cardiac condition includes connecting the patient to a cardiac monitor. The purpose of the monitor is to (1) measure the heart rate (heart beats per minute) and (2) identify the presence or absence of an arrhythmia, which is an irregularity of the heart beat. In connecting the monitor to the patient, 3-5 electrodes are placed on the patient’s torso. In addition, every patient with a potential cardiac disorder will receive a standard 12-lead resting electrocardiogram (ECG), which is the cornerstone of Cardiovascular Disease (CVD) testing. The 12-lead ECG is measured from the placement of an additional 10 electrodes on the body surface using a different, portable, and stand-alone machine that requires a technician for acquisition. After the patient is placed on the monitor, and while waiting for the acquisition of the 12 lead ECG, the patient’s blood will be drawn and sent to the laboratory for routine analysis and detection of serum chemical markers, such as CPK and cardiac troponin. The purpose of drawing these cardiac marker blood tests is to detect the presence of an acute myocardial infarction (AMI). It may take an hour or more for the results of these blood tests to be presented to the physician for interpretation and will be repeated every 4-6 hours for the next 18-24 hours to see if the chemical marker levels increased, which is an indication of an AMI.
VectraCor has developed and patented a technology that will differentiate the current mature monitoring market by enhancing the cardiac monitor to incorporate all three processes above into one device from only 3 leads (5 electrodes).
Additionally, and perhaps more importantly, VectraCor’s technology will incorporate the world’s first patented “Cardiac Electrical Biomarker” (VectraplexAMI) for the real-time detection of ECG changes suggestive of an AMI. No other company has patented, developed and marketed a technology of this kind. The VectraplexAMI will be displayed on the cardiac monitor as a number in real-time, in the same manner as the heart rate. VectraCor’s VectraplexAMI index is displayed in real time and may change if the patient unknowingly begins to develop ECG changes suggestive of an AMI, setting up an internal and audible alarm that can result in the display/print-out of the derived 12-22 lead ECG (15 leads in US and pending CE Mark for a derived 22 Lead ECG) and will prompt the user to acquire a standard 12 lead ECG (by adding the 5 additional electrodes from the same system) for interpretation by the physician.
VectraCor’s vision is to have our technology become the new standard of care within every Cardiac Monitor, ECG Machine, Stress Test Device, Holter Monitor, Event Monitor, Defibrillator, etc.
The 22 lead ECG VectraplexECG System is CE Mark and available for the European market.