Coronary Imaging System Developed for the Identification of Plaques

Such plaques, which cannot be detected by typically used tests such as a treadmill examination and even coronary angiography, are suspected to be the cause of most sudden cardiac deaths and non-fatal heart attacks.

InfraReDx, Inc. (Burlington, MA, USA) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its catheter-based LipiScan coronary imaging system. The availability of this novel tool culminates a decade-long biomedical engineering effort to create an instrument that could perform spectroscopy in the arteries of patients with coronary artery disease. The identification of the chemical composition of coronary plaques is expected to be of value to cardiologists in the selection of medical, stenting, or surgical therapy for coronary lesions. The device is also expected to be of value to the pharmaceutical industry as a means to assess the effect of novel anti-atherosclerotic agents on lipid-core plaque burden.

"The InfraReDx team is pleased that the LipiScan system has been validated in tissue samples and a clinical study and has been cleared by the FDA for use in patients. We understand the great potential of interventional cardiology, and anticipate that this novel tool will assist physicians with the complex decisions they face in the management of patients with coronary artery disease,” stated James E. Muller, M.D., cardiologist, co-founder, president and CEO of InfraReDx.

"There is a real unmet medical need to identify lipid core-containing plaques of interest in the coronary arteries, which before now we could not do,” noted James Goldstein, M.D., director of research and education at William Beaumont Hospital in Royal Oak, Michigan, who is also an investigator in the SPECTACL clinical trial for the device and a consultant for InfraReDx. "The ability to detect lipid core containing plaques of interest may go a long way in providing information to help prevent heart attacks in the near future.”

Near-infrared (NIR) spectroscopy is commonly used to measure the chemical composition of unknown substances. The LipiScan coronary imaging system utilizes advanced optical technology, much of it developed for telecom uses, to deliver and retrieve NIR light from coronary plaques. The light reflected back at different wavelengths is analyzed to detect the chemical composition of the coronary plaques. At the completion of the catheter pullback, the LipiScan console instantly displays the scan results on a "chemogram,” a digital color-coded map of the location and intensity of lipid core containing plaques of interest in the artery. A Lipid Core Burden Index is also reported, which is a measure of the total amount of lipid core containing plaques of interest in the coronary artery. The LipiScan catheter interrogates each artery in less than two minutes and does not require the interruption of the flow of blood.

The SPECTACL clinical trial documented the similarity of near-infrared spectra obtained from 106 patients undergoing coronary angiography compared to spectra obtained in autopsy specimens in which the gold standard of histology was available.


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