InfraReDx, a medical device company developing cardiovascular diagnostic imaging technologies, has received US Food and Drug Administration (FDA) 510(k) clearance to market LipiScan intravascular ultrasound (IVUS) coronary imaging system.
The LipiScan is a cardiac catheter combining IVUS and near-infrared (NIR) spectroscopy to help cardiologists identify and characterise the plaques that complicate stenting and are associated with acute coronary events.
The IVUS provides an image of plaque structure and stent features where as the NIR spectroscopy identifies the chemical content of the plaques
The LipiScan IVUS’ design provides physicians with a grayscale IVUS image of the coronary artery along with a complete and co-registered chemogram, a map of LCP within the imaged vessel.
InfraReDx founder and CEO James Muller said that they are pleased to have achieved the important milestone of FDA marketing clearance for LipiScan IVUS, multi-modality, single-catheter device that provides improved characterization of coronary plaques.
“Interventional cardiologists adopting the LipiScan IVUS system will be able to quickly and accurately identify the presence and structural features of lipid-core plaques in the coronary arteries. Such knowledge will assist them in the conduct of the stenting procedure and provide information useful in the treatment of patients post-stenting,” Muller said.