Designation represents progress for patients with suspected Coronary Microvascular Dysfunction as the FDA recognizes disease’s debilitating impacts and the lack of effective non-invasive options for efficient diagnosis
MASON, Ohio–(BUSINESS WIRE)–Genetesis, Inc., the leader in biomagnetic cardiac imaging solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device designation for its flagship imaging solution, CardioFlux MCG, to identify myocardial ischemia in patients who may be suffering from coronary microvascular disease (CMD). Historically, CMD has been hard to identify in clinical practice due to a lack of effective functional diagnostics with adequate sensitivity and an outdated perception that CMD is largely benign and non-fatal.
Annually, as many as 4 million patients in the United States alone are believed to present with diagnostic evidence of ischemia without evidence of obstructed coronary arteries, a condition broadly known as INOCA. Patients living with CMD represent one of the most common subgroups of this population, and these patients have been shown to suffer from substantially higher rates of hospitalization and subsequent cardiovascular disease progression.
The FDA’s decision rested, in part, on the submission of preliminary findings from the MICRO trial, which attempted to demonstrate the use of non-invasive magnetocardiography (MCG) to diagnose myocardial ischemia in patients suspected to be suffering from CMD. This effort was supported in large part by The Christ Hospital, whose participation in MICRO helped to identify a majority of the patients that participated in the study. “Many of the patients I see who I find to have CMD come to me with a history of past stress tests that either failed to show abnormalities or were largely inconclusive,” said Dr. Odayme Quesada, M.D., Medical Director of the Women’s Heart Center at The Christ Hospital Health Network and Principal Investigator on MICRO. “If MCG works as intended and can lead to far earlier management of CMD, it’s exactly these patients who stand to benefit the most.” Early data from MICRO has been submitted as an abstract to the European Society of Cardiology national meeting.