CardiArc Ltd. Receives FDA Approval to Market New Hi-Res Imaging Device

LUBBOCK, Texas, Jan. 25 /PRNewswire/ — CardiArc Ltd. today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new cardiac SPECT imaging device which could lead to better cardiac diagnosis and fewer hospitalizations to rule out heart attacks. Physicians will soon have sharper images of blood flow and function of their patients’ hearts – in half the time previously required.

CardiArc has developed and patented a new, smaller and faster technology for cardiac single photon emission computed tomography (SPECT) with twice the resolution of existing devices. The CardiArc(R) system is as small as an executive chair, runs on 110 Volts AC and fits easily in a 6-by-7 foot exam room without remodeling. The device has no visible moving parts and uses solid-state CZT technology (cadmium zinc telluride). Patients sit upright, without rotating or holding arms over their heads. Scan times are very fast, ranging from 2 to 6 minutes at physician discretion.

“The CardiArc(R) imaging system provides a high level of patient comfort and much clearer images for the cardiologist, in less than half the time of existing SPECT devices,” said Jack Juni, MD, the inventor, chairman and CTO of CardiArc(R). “This will result in more cost-effective and better cardiac care with optimal diagnostic and prognostic accuracy.”

The CardiArc(R) SPECT device has been specifically designed for use in outpatient settings and emergency rooms. It can pass through a standard 30- inch wide door, can be used in a 6 x 7-foot exam room, requires no room modifications for installation or operation and uses U.S. or European standard voltage. Power consumption is less than 350 watts.

SPECT is a standard noninvasive diagnostic imaging procedure performed and widely available in most hospitals and some outpatient clinics. It creates very accurate, three-dimensional images of blood flow and function of a major organ, such as the heart or brain. Energy from a radionuclide (tracer) which has been injected into the body is detected by a scanner, which takes a number of images from different angles, similar to the way a CAT scan produces images. SPECT is highly accurate in detecting coronary artery disease.

In a study published in the Journal of the American Medical Association (JAMA), researchers found that incorporating a heart imaging procedure into the initial evaluation strategy of patients suspected of having a heart attack could help physicians more accurately establish which patients were, in fact, suffering from acute cardiac ischemia (an inadequate supply of blood to heart muscle, caused by partial or total blockage of an artery). This, in turn, helped to cut down unnecessary hospitalizations, without decreasing appropriate admissions of patients with acute ischemia.

That study, conducted using devices with much longer imaging times and much lower resolution than CardiArc’s new device, showed that SPECT imaging is an important new tool for emergency department physicians making admitting decisions about patients suspected of having a heart attack. For patients with possible heart disease, the technology can mean early diagnosis and for those evaluated for heart attacks, fewer hospitalizations.