FDA gives thumbs-up to Genetesis MCG cardiac imaging system

CardioFlux platform

March 25, 2019
by John R. Fischer , Staff Reporter
The FDA has given the thumbs-up to Genetesis’ cardiac imaging platform, CardioFlux.

The platform performs simple, fast and noninvasive cardiac scans using magnetocardiography (MCG), a technique that measures magnetic fields produced by electrical activity of the heart, and then transfers information securely to the Faraday Analytical Cloud (FAC) where it can be viewed by physicians. It also possesses optically pumped magnetometers (OPM), which eliminate the need for liquid helium and the challenges it brings to the use of MCG systems.

“The helium level is sealed in welded stainless steel vessels, the level loss is negligible, and an annual top-off of the level, if needed, is done by suppliers,” Robert Sokolowski, vice president of clinical, regulatory and quality at Genetesis, told HCB News. “MCG systems using liquid helium-based technology cannot use weldable metallic vessels, and liquid helium is lost at rapid rates from the fiberglass vessels employed, necessitating system refills of liquid helium as often as twice a week. Optically pumped magnetometers (OPM) used in the Genetesis system do not require any cooling, liquid helium or otherwise.”

The use of the OPM technology saves on the hassle and cost of storing portable liquid helium tanks for refills near the MCG system, and protects hospital technicians from the dangers of the refilling process, with liquid helium posing a burn risk if it comes into contact with skin.

Unlike conventional echocardiograms, which are influenced by differently conductive body tissue and various levels of skin resistance before they can be recorded, magnetic signals are able to travel through the patient without disturbances and are vector-based measurements, making them efficient sources of useful clinical information necessary for advanced and more accurate cardiac diagnoses.

Once this functional imaging data has been collected, it is stored in the FAC where physicians can access it, along with a set of web services. Hospitals can also use it to leverage an integrated billing service.

An investigational study involving Genetesis and Ascension St. John’s Hospital’s Emergency Department Observation United concluded that the solution has the potential to positively impact clinical workflows of patients admitted to EDs with chest pain or angina equivalents, a case load that reaches nearly 10 million annually. The findings were presented at the American College Emergency Physicians (ACEP) 2018 Scientific Assembly.

Working again with Ascension St. John Hospital, as well as two other institutions, the company plans to conduct a larger, multicenter study on the use of MCG for diagnosing myocardial ischemia, coronary artery disease and other cardiovascular conditions.

“We are launching the largest multicenter trial focused on the ability of magnetocardiography imaging, leveraging CardioFlux FAC, to detect myocardial ischemia. The CardioFlux results will be directly compared with coronary angiography, FFR, and iFR data in up to 1,500 high-risk patients,” Alisa Niksch, chief medical officer at Genetesis, told HCB News. “Genetesis will be working with Ascension St. John Medical Center and two other sites under development. We believe that this study will have a high impact with cardiologists and emergency physicians making pivotal clinical decisions for patients with similar cardiac risk factors.”

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