A Medical Device Daily
InfraReDx (Burlington, Massachusetts) said it has received FDA clearance for its catheter-based LipiScan coronary imaging system. The LipiScan device uses near-infrared spectroscopy to identify lipid core containing plaques of interest in the coronary arteries in patients already undergoing cardiac catheterization. Such plaques, which cannot be detected by commonly used tests such as a treadmill exam and even coronary angiography, are suspected to be the cause of most sudden cardiac deaths and non-fatal heart attacks.
Near-infrared (NIR) spectroscopy is used to measure the chemical composition of unknown substances. The LipiScan system uses 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.
"The InfraReDx team is pleased that the LipiScan 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," said James Muller, MD, cardiologist, co-founder/president/CEO of InfraReDx.