CE Mark and EU Launch of MyoVista® High Sensitivity ECG Device

HeartSciences has announced the European launch of MyoVista® high sensitivity electrocardiograph (hsECG™) Testing Device, for low-cost, front-line screening of cardiac disease in both symptomatic and asymptomatic patients.

Background

HeartSciences says it is bridging today’s “diagnostic gap” in cardiac care by providing low-cost effective solutions that help to identify at-risk patients prior to experiencing an adverse cardiac event, such as a heart attack. Using patented, proprietary technology, the company develops medical devices that focus on the early detection of heart disease.

Electrical, structural, and coronary artery disease (CAD) comprise the three main categories of heart disease. Existing ECG technology, which functions essentially in the same way as when first introduced in 1903, has limited effectiveness in detecting structural and CAD. Even though it is the front-line screening tool used by physicians to detect heart disease, conventional resting ECG technology detects CAD less than 50 percent of the time, which leaves a large number of patients who have heart disease undiagnosed. As a result, current healthcare guidance does not recommend use of ECG testing on asymptomatic patients.

The application of advanced signal processing technology assists in closing the diagnostic gap by providing a low-cost, front-line tool for the early detection of cardiac dysfunction. During the validation trial, MyoVista hsECG technology detected cardiac dysfunction in the resting (diastolic) phase of the cardiac cycle with 88 percent sensitivity and 87 percent specificity. The 200-patient trial assessed the presence of left ventricular diastolic dysfunction.

MyoVista hsECG uses the same 12-lead, at-rest testing protocol as traditional ECG devices on the market today to help facilitate easy adoption for clinical staff. The difference is that MyoVista is a single test that provides healthcare practitioners with unique informatics, as well as conventional 12-lead resting ECG tracings and conventional ECG interpretive analysis. In combination, these assist identification of cardiac dysfunction related to CAD and structural disease, as well as identifying arrhythmias.

MyoVista hsECG has received CE Mark approval. HeartSciences expects to seek U.S. FDA clearance in 2018.

Physician comments

“Innovation is needed to advance front-line testing of patients for heart disease,” said Dr. Partho P. Sengupta, chief of Cardiology and chair of Cardiac Innovation at West Virginia University, and lead investigator on a MyoVista clinical trial. “High sensitivity ECG technology holds significant promise for improving the detection of heart disease.”

Company comments

“Currently, there’s a significant diagnostic gap in detecting heart disease early, resulting in a burden on both patients and healthcare systems,” said Andrew Simpson, chairman, HeartSciences. “We believe MyoVista hsECG could play an important role in achieving the preventative treatment ambitions of many healthcare systems as well as help reduce unnecessary healthcare expenditures.”

“It makes sense to use advanced signal processing to create a modern, low-cost, front-line tool to detect heart disease,” said Mark Hilz, chief executive officer, HeartSciences. “While MyoVista represents a first-of-its-kind application to electrocardiographic testing, advanced signal processing has already enabled key imaging technologies such as computed tomography (CT) scans, magnetic resonance imaging (MRI), Doppler echocardiography and positron emission tomography (PET) scans.”

Source: PR Newswire

 

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