FDA Clears First Device That Non-invasively Screens for Heart Disease

WASHINGTON (Reuters Health) – The US Food and Drug Administration (FDA) has approved Hypertension Diagnostics, Inc.’s (HDI) CVProfilor DO-2020 CardioVascular Profiling System, the first device that can non-invasively screen patients for cardiovascular disease.

The company’s shares soared 28% on Friday following the announcement of the approval.

The CVProfilor system, which incorporates the company’s patented “waveform” technology, can be used in physician’s offices and clinics and involves “no specific medical risk to the patient,” the company stressed in a new release issued on Friday.

The CVProfilor measures not only the standard heart disease markers, such as systolic and diastolic blood pressure, mean arterial pressure and heart rate, but also evaluates pulse pressure, body surface area, body mass index and arterial elasticity, the St. Paul, Minnesota-based firm noted.

The device also assesses the patient’s large and small artery elasticity, or C1 and C2 parameters, respectively, serving as an initial screening tool for detecting potential vascular disease that requires further, more targeted diagnosis.

The CVProfilor can detect even the slightest loss of arterial elasticity, the early detection of which usually precedes more overt symptoms of heart disease, Dr. Charles F. Chesney, HDI executive vice president and chief technology officer, noted.

The system then generates the arterial elasticity results on a display screen and in a printout, the company said.

Existing clinical data, published in more than 95 medical journals, has already established a link between a patient’s age and loss of arterial elasticity, as well as a correlation between hardening of the arteries and vascular disease.

What’s more, research shows that premature stiffening of the arteries is a classic marker for early onset of cardiovascular disease, with the condition being found in patients with hypertension, heart failure, coronary artery disease and diabetes, the company noted.

About 60 million Americans have high blood pressure, and heart disease remains the leading cause of death in the US. In fact, over 2,600 US patients die of cardiovascular disease every 24 hours–about one death per 33 seconds, according to HDI estimates.

In Friday trade on the NASDAQ, shares in Hypertension Diagnostics climbed 1-3/4 to close at 8.