Mason, OH - Thursday, January 30, 2020 - Undiagnosed chest pain sends 8-10 million Americans to Emergency Departments annually, making it the second most common complaint. Emergency physicians must rapidly identify patients whose chest pain is cardiac-related. A new pilot study has found that a resting 90-second magnetocardiography (MCG) scan shows promise in evaluating emergency department observation unit (EDOU) chest pain patients for Acute Coronary Artery Syndrome. The publication also indicates that CardioFlux MCG may provide additional information to support the usual clinical pathway of Stress Testing and Coronary Angiography.
Genetesis, Inc. today announced the publication of the company's initial pilot study of its CardioFlux FAC Magnetocardiograph, conducted by a team of emergency medicine physicians at a major cardiac hospital in Detroit, MI. CardioFlux MCG is a novel medical device that can now non-invasively measure and visualize the well-studied electromagnetic function of the heart. A CardioFlux scan is performed at rest and without the use of radiation or pharmaceuticals to record the magnetic field map generated by the electrical activity of the myocardium. These fields have previously been shown to change with cardiac ischemia due to dysfunction of the ion channels responsible for repolarization and depolarization of the myocardium. The study titled "A 90-second Magnetocardiogram Using a Novel Analysis System to Assess for Coronary Artery Stenosis in Emergency Department Observation Unit Chest Pain Patients" was published online by the International Journal of Cardiology Heart and Vasculature on January 8th, 2020.
Only a small minority of patients will ultimately be diagnosed with Acute Coronary Syndrome yet most are still placed in an observation unit for additional tests and monitoring. This leads to longer hospital stays, a higher cost of care, and unnecessary downstream tests that expose patients to radiation and pharmaceuticals. CardioFlux has the potential to substantially reduce cost and wait times while improving patient experience and outcomes.
"Having a non-invasive diagnostic test that can be performed rapidly with almost no patient preparation in the emergency department observation unit or possibly incorporated into the ER workflow would be a game-changer in the evaluation of ED patients presenting with chest pain" says Dr. Margarita Pena, lead author of the pilot study. "This has a lot of potential to screen patients out [for] Coronary Artery Disease, not to mention the benefits of avoiding risks to the patient associated with radiation, adverse reactions to pharmacologic and contrast agents, as well as risks associated with hospitalization."
In the prospective emergency department observation unit clinical study, 101 low-intermediate risk chest pain patients were administered a 90-second noninvasive heart scan using the CardioFlux MCG. Cardioflux identified different magnetic field maps for patients with and without myocardial ischemia diagnosed via standard of care evaluation. CardioFlux performed competitively relative to stress testing and coronary angiography, with a demonstrated specificity of 78.3% and a negative predictive value (NPV) of 92.3%. These results are the beginning of a robust set of data demonstrating that CardioFlux shows promise as a "feasible and comparable testing option" relative to standard of care stress testing. The data were previously presented at the American College of Emergency Physicians Scientific Assembly in October 2018.
Dr. Pena notes that further research on CardioFlux is underway. "Now they're looking at the high-risk population of patients that get [catheterized] so that we can see how this compares to catheterization," says Pena.
"While previous studies of magnetocardiography have yielded promise in the detection of coronary artery disease, this is the first time a scalable iteration of this technology has been made available to emergency medicine in their difficult task of diagnosing ACS," Dr. Alisa Niksch, Genetesis Chief Medical Officer, stated. "This data has given Genetesis the momentum to expand research into other populations at risk for ischemic heart disease."
The CardioFlux FAC MCG system is FDA cleared and is available for sale in the United States.
Genetesis, Inc. is a medical technology company focused on redefining the way myocardial ischemia and coronary artery disease are detected. By combining CardioFlux, our noninvasive biomagnetic imaging technology, with proprietary cloud-based web services and machine-learning capabilities, we seek to become the standard of care for diagnosis of clinically significant myocardial ischemia in the acute care setting. Genetesis was founded in 2013 and is based in Mason, Ohio. https://genetesis.com
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