InfraReDx Wins Approval for Coronary Imaging System
Posted on: Wednesday, 30 April 2008, 09:01 CDT
Medical divice firm InfraReDx has received 510(k) clearance from the FDA to market 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 examination and even coronary angiography, are suspected to be the cause of most sudden cardiac deaths and non-fatal heart attacks.
James Muller, co-founder, president and CEO of InfraReDx, said: "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."
Source: Datamonitor
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