Novel Spectroscopy Imaging System Identifies Lipid-Core Coronary Plaques

On April 25, 2008, the US Food and Drug Administration (FDA) granted clearance to InfraReDx, Inc. (Burlington, MA, USA) for marketing of its LipiScan system to identify lipid core containing coronary plaques. Dr. Daniel Schultz, director of the FDA Center for Devices and Radiological Health, stated, "This is the first device that can help assess the chemical make-up of coronary artery plaques and help physicians identify those plaques with lipid cores, which may be of particular concern.” A report on the scientific validation of the device was published the September 2008 issue of the JACC Imaging, an official publication of the American College of Cardiology.

Following this validation and FDA clearance, five leading cardiovascular centers in the United States adopted the system and used it for routine clinical care in over 50 patients undergoing coronary artery disease stenting procedures. These physicians reported on their initial experience with the device in multiple presentations at the Transcatheter Cardiovascular Therapeutics (TCT) Conference, held in Washington DC, USA, October 12-16, 2008. The TCT is the world's leading meeting for those performing coronary diagnostics and stenting.

The system utilizes spectroscopy, which is widely used to determine chemical composition of unknown materials, and is performed inside the coronary artery of a living patient. Dr. Craig M Gardner, director of algorithm development at InfraReDx and lead author of the validation manuscript explained that, "NIR spectroscopy is sensitive to the chemical composition of tissue, can penetrate through several millimeters of blood, and can collect measurements rapidly through thin and flexible optical fibers.”

"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, cofounder and CEO of InfraReDx.

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