CardioDefender™: A major advance in the early diagnosis and treatment of heart arrhythmia.
CardioDefender1 is the first FDA-approved and CE mark-registered smartphone ECG system to provide physicians and patients with hospital-quality heart rhythm monitoring outside of the hospital setting. The system incorporates several unique capabilities enabling physicians to diagnose and treat potentially life threatening arrhythmias that might otherwise be missed.
CardioDefender is the first system to deliver mobile, real-time, beat-by-beat, and quantitative heart monitoring and automated reporting by combining patented analytical smartphone software with a Bluetooth device and electrodes.
The facts about heart arrhythmia:
A heart arrhythmia (also called dysrhythmia) is an irregular or abnormal heartbeat. Heart rhythm problems (heart arrhythmias) occur when the electrical impulses in your heart that coordinates your heartbeats don't work properly, causing your heart to beat too fast, too slow or irregularly. The effect of these electrical impulses on your heart can be seen with an electrocardiogram (ECG or EKG) evaluation.
Incidence of arrhythmia:
The Joint Committee of the AHA/ACC (American Heart Association/American College of Cardiology) recommends that everyone over 40 years of age should be examined for potential heart arrhythmias. In United States, India, and China alone there are ~849 million people at risk of heart arrhythmias.
- In the United States alone, more than 4 million people a year suffer from recurrent arrhythmias warranting a physician’s care; about 780,000 people are admitted to the hospital for arrhythmias annually.
- In India it is estimated that 18 million people suffer from recurrent arrhythmias annually
- In China about 20 million people suffer from recurrent arrhythmias annually
Some people who feel arrhythmias don't have a serious problem, while others who have life-threatening arrhythmias have no symptoms at all.
Ventricular fibrillation (VF) is one type of arrhythmia that is deadly. It occurs when the heart beats with rapid, erratic electrical impulses. This causes pumping chambers in your heart (the ventricles) to quiver uselessly, instead of pumping blood. Without an effective heartbeat, blood pressure plummets, cutting off blood supply to your vital organs. A person with ventricular fibrillation will collapse within seconds and soon won't be breathing or have a pulse.
How is arrhythmia diagnosed?
In order to correctly diagnose and treat an arrhythmia it is essential that the type of arrhythmia is identified; this requires the patient to receive a quantitative electrocardiogram (also known as an ECG or EKG); the patient’s physician will analyze this data to help them determine the correct diagnosis and treatment.
An ECG is a non-invasive test that records the heart's electrical activity. With each heartbeat, an electrical signal spreads from the top of the heart to the bottom. As it travels, the signal causes the heart to contract and pump blood. The process repeats with each new heartbeat.
The heart's electrical signals set the rhythm of the heartbeat. An ECG shows:
- How fast your heart is beating
- Whether the rhythm of your heartbeat is steady or irregular
- The strength and timing of electrical signals as they pass through each part of your heart
Doctors use ECGs to detect and study many heart problems, such as heart attacks, arrhythmias, and heart failure. The test's results also can suggest other disorders that affect heart function.
Limitations of current ECG diagnostic systems:
It is impossible to predict when a heart arrhythmia will occur. Once one has occurred, it is equally difficult to predict when the arrhythmia will reoccur. Hours, weeks or months may elapse between arrhythmia events. It is only when these arrhythmia events occur that a physician can collect important heart rhythm data required for an accurate diagnoses and treatment.
The optimal ECG system is required to deliver real-time, beat-by-beat, quantitative monitoring, analysis and alerts; the optimal system will deliver this level of performance both in the hospital and the home-setting. It must have a unique combination of high-performance, ease of use and cost characteristics to deliver these requirements.
Until now, with the introduction of the CardioDefender ECG system by Everist Genomics, none of the legacy ECG systems met the required performance capabilities. Limitations of existing systems include:
Limitations of Hospital Based Systems:
- Although the quality of heart rhythm data and analysis is very good, the sampling period of hospital based ECG systems is usually too short (typically limited to a few days) to allow capture of an infrequent (but potentially serious) arrhythmia.
- In theory the period of observation could be extended, but to do so is impractical and expensive. Patients are also resistant to long term hospital based ECG monitoring.
- Observation of patients on a telemetry unit in the hospital also has severe limitations, especially poor patient acceptance.
- Because the time-window of monitoring the heart rhythm is typically confined to a few days, the physicians’ ability to accurately diagnose and treat an arrhythmia is severely constrained.
Limitations of Portable ECG Recorders and Holter Monitors:
- Portable ECG recorders and Holter monitors enable monitoring outside the hospital but none provide real-time, beat-by-beat, quantitative heart rhythm monitoring of symptomatic and asymptomatic events.
- Portable ECG recorders and Holter monitors are typically limited to less than 4 hours or 6 events of actual event recording time. This provides a relative short window of ECG recording time.
- When the heart rhythm data is being transmitted to the monitoring center the ECG recorder cannot record new and potentially important data.
- The process which patients have to follow in order to transmit heart rhythm data to a monitoring center can be complex and time consuming.
- Because the time-window of monitoring the heart rhythm with portable ECG recorders and Holter monitors is typically confined to a short period of time the physicians ability to accurately diagnose and treat an arrhythmia is severely constrained.
CardioDefender: A major advance in ECG monitoring to assist physicians in the early diagnosing and treatment of arrhythmia
The Everist Genomics CardioDefender system is a major advance in ECG monitoring and overcomes the limitations associated with legacy ECG systems.
CardioDefender is the world’s only FDA and CE Mark approved smartphone based, fully mobile ECG system which provides physicians and patients with the quality of hospital-based ECG systems; real-time, beat-by-beat, quantitative heart monitoring and reporting but utilizing the convenience of mobile, wireless technology.
The breakthrough performance capabilities of CardioDefender include:
- Approved by US and European regulatory authorities; CardioDefender is FDA approved and CE Mark. Use of the CardioDefender system is also reimbursed in the USA and Europe.
- Fully mobile system; CardioDefender is the world’s first ECG system which delivers hospital based quality ECG and arrhythmia analysis by integrating unique software, algorithms and data compression capabilities which enable a smartphone to perform as a mobile ECG
- Real-time, heart-rhythm monitoring
- Beat-by-beat analysis of heart rhythm (as opposed to sampling some heart beats or part of a heart beat)
- Long term monitoring capability; CardioDefender can perform up to 3 months of real-time, beat-by-beat quantitative patient monitoring and analysis
- Quantitative analysis and reporting; CardioDefender is a fully automated, quantitative ECG monitoring and arrhythmia event reporting system
- Comprehensive range of heart rhythm monitoring algorithms to enable automated detection and reporting of medically important arrhythmias to physicians and monitoring centers
- Abnormal heart rhythms reported directly to physicians mobile phone or computer; innovative and patent protected software and data compression technology means CardioDefender can report real-time results to a physician’s smartphone, tablets, laptop and desk top computer (in addition to a cardiac monitoring center)
- Access to full, detailed ECG data captured during the monitoring period, including post heart monitoring data processing for additional measurements
- Real-time reporting of symptomatic and asymptomatic arrhythmias; CardioDefender has the ability to capture and report both symptomatic and asymptomatic arrhythmias
- Marketed in the United States and EU as PocketECG