InfraReDx Announces FDA Clearance Of Its Near Infrared Spectroscopic System For Examining Coronary Arteries

BURLINGTON, Mass., Oct. 19 /PRNewswire/ -- InfraReDx today announced that the U. S. Food and Drug Administration recently issued a clearance for the company's 510(k) application to market its near infrared (NIR) spectroscopic system for examining coronary arteries.

"This clearance represents a major milestone in our efforts to provide a tool for the assessment of coronary artery disease," said Dr. James Muller, the company's founder, CEO, and president, explaining that it will enable cardiologists to characterize the composition of coronary artery plaques.

InfraReDx was founded to bring the benefits of photonic technology to the task of identifying lipid-rich plaques. Although prospective evidence is not currently available, these plaques are suspected to be "vulnerable" to rupture, subsequently leading to thrombosis and a heart attack. If such plaques could be identified in advance -- which coronary angiography, the current-standard-of care, is unable to do -- there are many potential treatments that could be evaluated.

The InfraReDx intracoronary spectroscopy system is a novel fiber-optic, catheter-based device with a laser light source. The catheter has been designed to perform spectroscopy in the difficult conditions of motion and blood flow presented by coronary arteries.

Noting that the 510(k) clearance was based largely on the results of research involving autopsy specimens, and experience in an initial ten-patient feasibility study, Dr. Muller emphasized that more extensive studies are currently in progress. A pivotal clinical study -- called SPECTacl (Spectroscopic Assessment of Coronary Lipid) -- is designed to document the ability of the InfraReDx system to identify distinctive near-infrared spectra in patients. To interpret the meaning of the spectra obtained in the SPECTacl study, a parallel study is being conducted on autopsy specimens in which a histologic gold standard is available.

InfraReDx recently closed a $22.3-million round of funding that will enable the company to complete and submit the results of ongoing studies, finalize product development efforts, and begin the process of preparing for a product launch, expected in 2007. The company expects that the first use of its products will involve patients undergoing percutaneous coronary intervention procedures such as stenting, which are performed on approximately two-million individuals per year.

InfraReDx, founded in 1998 and headquartered in Burlington, Massachusetts, is a privately-funded company developing a fiber-optic, catheter-based, near-infrared (NIR) spectroscopy system to detect lipid-rich plaques in the coronary arteries, which are suspected to be vulnerable plaque, the most frequent cause of heart attacks. For more information, visit http://www.infraredx.com.

Contact: Nandini Murthy Arthur Dimond InfraReDx, Inc. Dimond Communications Consulting 781/221-0053 ext. 221 508/255-0221 nmurthy@infraredx.com arthurdimond@aol.com

Source: InfraReDx

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