LipiScan IVUS coronary imaging system receives CE mark


LipiScan IVUS coronary imaging system (InfraReDx) received CE mark approval on 20 April 2011. The LipiScan IVUS is the only device available in both the US and Europe for the detection of the plaques known to complicate stenting and believed to be the reason for most heart attacks, InfraReDx stated.

“With the US launch of the system well underway, we are already receiving tremendous interest from physicians in Europe and are in active discussions with prospective distributors of the product. We are currently finalising our European marketing plan and expect to launch the LipiScan IVUS in selected countries in the coming months,” said Donald Southard, president and chief executive officer of InfraReDx.


The LipiScan IVUS Coronary Imaging system received FDA approval in June 2010. The system includes the world’s first and only cardiac catheter to combine intravascular ultrasound (IVUS) and near-infrared (NIR) spectroscopy to help cardiologists identify and characterise lipid core coronary plaques. In a single catheter pullback, the LipiScan IVUS provides physicians with a traditional IVUS image that clearly displays key structural parameters of the lesion, including its location, length, and degree of stenosis, in addition to confirming proper stent placement. At the same time, the system performs spectroscopic analysis of optical data to produce a Chemogram map that indicates the location of lipid core plaques and quantifies their lipid core burden.


Integrating and co-registering the Chemogram with IVUS provides critical information to interventional cardiologists during the cardiac catheterisation procedure.


“The LipiScan IVUS system is an important new intravascular imaging tool that will be of immediate value to interventional cardiologists for the diagnosis and management of their patients,” said Patrick W. Serruys, professor of interventional cardiology at the Thoraxcenter, Erasmus University Hospital, Rotterdam, Netherlands. “This impressive multimodality system provides an IVUS image of the vessel while simultaneously performing spectroscopic analysis for the accurate and immediate detection of lipid core plaques demonstrated to complicate stenting and suspected to cause most heart attacks. The Thoraxcenter is proud of its association with InfraReDx and the role we have played in the development of the LipiScan IVUS system and imaging catheter.”