Biomagnetic imaging for chest pain wins FDA clearance
- A biomagnetic imaging platform from Mason, Ohio-based Genetesis has received FDA 510(k) clearance for evaluating patients with chest pain for possible coronary artery disease (CAD) and myocardial ischemia, in which the heart is not getting enough blood and oxygen.
- Called CardioFlux, the noninvasive imaging test measures the magnetic fields produced by the heart's electrical activity and is intended for use by emergency room physicians and cardiologists.
- Genetesis completed an investigational study of 101 patients using a prototype CardioFlux device at Ascension St. John Hospital in Detroit. The company said it is now collaborating with several sites to launch a larger multi-center study using the technology, called magnetocardiography (MCG).
Determining the best approach for the initial evaluation of patients with stable chest pain is a subject of much debate. Chest pain is the second most common reason for emergency department visits in the United States each year, after stomach pain, accounting for more than 7 million visits, according to the Centers for Disease Control and Prevention. Yet most patients who undergo testing are not found to have coronary ischemia, according to one study of insurance claims for almost 930,000 patients.
Current U.S. guidelines support noninvasive stress tests to measure heart function for most patients with chest pain. A recent Mayo Clinic study concluded that non-invasive stress testing in patients with a normal resting electrocardiogram (ECG) who are able to exercise is efficient in referring the appropriate patients for further, invasive testing and percutaneous coronary intervention or coronary artery bypass grafting (CABG).
Coronary computed tomography angiography (CTA), an alternative noninvasive test, is recommended for patients who are unable to undergo stress tests or who have received inconclusive results from those tests. CTA combines a scan with a contrast dye injected intravenously to enhance images of blood vessels.
Advancements in CTA have led some experts to call for broader adoption of the test for patients with stable chest pain. CTA differs from invasive coronary angiography in which a catheter is threaded through the arteries to detect blockages, guided by X-ray with a contrast agent. Invasive angiography remains the standard for detecting CAD, and traditionally is used after initial stress testing or for high risk patients.
Genetesis said its goal is to give clinicians an accurate and easy-to-operate tool that spares patients from invasive and lengthy testing. The scan takes less than 90 seconds. The CardioFlux unit is integrated with a cloud computing-based artificial intelligence infrastructure to generate a clinical report with images of cardiac function from the biomagnetic data in less than five minutes, the company said on its website.
Investors in the startup include Mark Cuban's Radical Investments, the Ohio Innovation Fund and Raptor Group.
- Genetesis Genetesis CardioFlux Platform Receives FDA 510(k) Clearance
- U.S. National Library of Medicine Magnetocardiography Using a Novel Analysis System (Cardioflux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients
- Journal of the American Heart Association Initial Diagnostic Evaluation of Stable Coronary Artery Disease: The Need for a Patient‐Centered Strategy
- Journal of the American College of Cardiology THE EFFECTIVENESS OF GUIDELINE-BASED STRESS TESTING IN THE EVALUATION OF STABLE CHEST PAIN IN A COMMUNITY POPULATION