While most heart murmurs are classified as harmless, it’s imperative that they are properly diagnosed in the event that a cardiac defect requires surgical repair. To support the detection of both innocent and pathological heart murmurs, AUM Cardiovascular has developed a non-invasive medical device which uses both acoustic and electrocardiogram (ECG) technology.
The company’s handheld CADence device makes a recording of the patient’s heart sounds which is then analyzed using an algorithm-based software program to create a report and help the physician make sense of the data. The medical device was recently approved by the US Food and Drug Administration (FDA) and is now available to help in the diagnosis of cardiac abnormalities in the country.
“The CADence system has the potential to dramatically enhance our ability to rule-out significant coronary artery disease and efficiently triage patients needing additional testing,” said study investigator Dr. Jay Thomas, an interventional cardiologist at Harbor-UCLA Medical Center in Los Angeles. “CADence is an exciting example of how novel technology will revolutionize patient care.”
In addition to helping physicians detect heart murmurs, AUM also intends to release another algorithm capable of identifying the hallmarks of stenosis, a condition in which plaque buildup clogs vital arteries. Stenosis is notoriously difficult to detect, particularly for family physicians.
Diagnostics commonly available in primary care – including devices which measure blood pressure, and lab tests to quantify low-density lipoprotein (LDL) cholesterol levels – cannot be used to detect stenosis. When compared to magnetic resonance imagining (MRI), computer topography and ultrasound, the CADence device could be a less-expensive and more accessible way for physicians to diagnose patients with stenosis.
Nearly 2,000 patients have been examined using the CADence medical device. It’s estimated that 10.5 million Americans experience chest pain each year, and cardiovascular diseases remain the number one cause of mortality around the world.
“It is a rapid, cost-effective, radiation-free way to evaluate selected patients with chest pain,” said Thomas. “The need for something like CADence is quite obvious considering how we have managed chest pain testing for the last twenty years.”
AUM is now pursuing regulatory clearance for another indication for the CADence device: ruling out obstructive coronary artery disease. The company has reported that their device performs on-par with the SPECT nuclear stress test – a procedure used to assess blood flow to the heart – in a clinical study of coronary artery disease.