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U.S. Department of Health and Human Services

For Consumers

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Device Identifies Fatty Deposits in Coronary Arteries

A new medical device allows doctors to see inside blood vessels to determine the fat content of the plaque buildup on the wall of the coronary arteries. The Food and Drug Administration (FDA) cleared the InfraReDx LipiScan NIR Catheter Imaging System for marketing in April 2008. It's the first device that can help assess the chemical make-up of coronary artery plaques and help doctors identify those of particular concern.

Why is plaque significant?

  • Plaque is a deposit made up of cholesterol-rich fat, calcium, and other substances found in the blood.
  • Coronary arteries supply the heart muscle with oxygen-rich blood. As plaque accumulates on the artery wall, it reduces blood flow to the heart muscle and increases the risk of blood clots, which can lead to a heart attack.
  • Many heart attacks occur when a fatty coronary plaque ruptures, forming dangerous blood clots.

How does the device work?

  • It uses infrared imaging to detect and assess the plaques of interest.
  • It places a catheter equipped with a fiber-optic laser light into the artery.
  • It shines the light delivered through the blood to the artery wall and measures the light reflected back from the wall, a technique called spectroscopy.
  • The measurement helps doctors determine how much fatty plaque buildup is in the artery.

LipiScan is manufactured by InfraReDx Inc. of Burlington, Mass.


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This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: May 1, 2008