ANN ARBOR — The medical device startup Everist Genomics Wednesday announced plans to commercialize its CardioDefender diagnostic system.
CardioDefender 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.READ MORE: Whitmer Tours Eastern Michigan University Vaccination Clinic
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 electrodes, which are attached to the patient’s skin, transmit heart rhythm data to the Bluetooth device, which then transmits the data to the smartphone. The smartphone software analyzes the heart rhythm data, and the data is sent to a cardiac monitoring center which keeps an encrypted record of the data that can be reviewed by physicians. Physicians are also able to receive arrhythmia alerts via their smartphone, tablet, laptop or desktop computer. In the event of a significant arrhythmia, the CardioDefender system will automatically transmit an alert to the patient’s physician while the event is occurring.
“Until now, heart rhythm monitoring for arrhythmia events has been limited by technologies that lack the level of sophistication needed to provide practical and useful monitoring for a mobile population,” said Prasad Sunkara, Everist CEO. “CardioDefender enables, for the first time, smartphone-based hospital-quality ECG monitoring of patients 24 hours per day, seven days per week.”
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 the United States alone, more than 4 million people a year suffer from recurrent arrhythmias warranting a physician’s care and about 780,000 people are admitted to the hospital for arrhythmias annually.READ MORE: Stimulus Check Update: Is A Fourth Relief Payment Coming?
Arrhythmias are a very common event — almost everyone occasionally experiences minor arrhythmias that don’t require medical attention. In contrast to these benign cases, however, some arrhythmias result in sudden cardiac death. In fact, most cases of sudden cardiac death are caused by a specific type of arrhythmia known as ventricular fibrillation. Ventricular fibrillation accounts for 75-80 percent of all SCDs in the United States. This type of arrhythmia also is often the first expression of coronary artery disease and is responsible for approximately 50 percent of deaths from CAD, often within the first hour after the onset of a heart attack or coronary syndrome.
Identifying patients at risk of having ventricular fibrillation remains a significant challenge. Although research shows that the risk of ventricular fibrillation is greater among people with a history of cardiac events such as heart attacks and cardiac arrest, only a small percentage of total ventricular fibrillation events usually occur in these patients. Identification of other types of heart arrhythmias also represents a major challenge as many arrhythmias occur without any signs or symptoms.
Conventional methods for monitoring and diagnosing arrhythmias have included hospital-based ECG systems, portable ECG recorders and Holter monitors, each of which present significant limitations. Hospital-based ECG monitoring, for example, typically limits the observation period to a few days, despite the fact that people who have intermittent arrhythmias, rarely experience them at the hospital or doctor’s office. On the other hand, ECG recorders and Holters enable physicians to monitor patients’ heart rhythm data remotely, but such devices do not provide real-time, beat-by-beat, quantitative heart rhythm monitoring. Moreover, portable ECG recorders and Holters are generally limited to less than 4 hours or 6 events of actual event recording time, and these devices cannot simultaneously transmit heart rhythm data to monitoring centers while recording new data.
Following FDA approval and European CE Mark registration last year, CardioDefender has already been deployed at more than 150 medical facilities in the United States for post-approval commercial evaluation. Between January and October of this year, the number of patient days of heart rhythm monitoring performed with CardioDefender grew from fewer than 5,000 to more than 18,000 patient days per month.
“The commercial evaluation of CardioDefender has been a big success as the system has already been widely adopted and used to provide heart rhythm monitoring for thousands of patients,” Sunkara said. “This further demonstrates the growing consensus among the medical community that it is time for a better approach to managing heart arrhythmia. By empowering physicians with the first mobile system to deliver real-time, beat-by-beat, quantitative monitoring and automated reporting, we are bringing the better approach to fruition.”
This novel diagnostic system represents a significant advance in Everist Genomics’ franchise of cardiovascular diagnostic and prognostic tests and complements the innovative AngioDefender diagnostic device for assessing endothelial function. The company plans to make the CardioDefender system commercially available to international markets in January 2012.MORE NEWS: Michigan Reports 9,674 New COVID-19 Cases, 12 Deaths For Sunday And Monday
Everist Genomics is a prognostics company focused on developing gene-based molecular assays for the prediction of cancer recurrence and proprietary point-of-care equipment for the evaluation and management of cardiovascular disease. Using its patented Evolver technology platform, Everist Genomics is successfully developing and commercializing entirely new classes of patent-protected molecular biomarkers and sensor technologies which employ proprietary equipment, devices and software to help physicians make individualized treatment and drug prescribing decisions. The privately owned company is located in Ann Arbor. For more information, please visit www.everistgenomics.com.