Near-Infrared Spectroscopic System Assesses Coronary Arteries

The catheter has been designed to perform spectroscopy in the difficult conditions of motion and blood flow presented by coronary arteries.

InfraReDx (Burlington, MA, USA) recently announced that the U.S. Food and Drug Administration (FDA) has 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 designed 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 detected in advance--which coronary angiography, the current-standard-of care, is unable to do--there are many potential treatments that could be assessed.

Noting that the 510(k) clearance was based mainly on the findings of studies involving autopsy specimens and experience in an initial 10-patient feasibility study, Dr. Muller stressed that more extensive studies are now in progress. A pivotal clinical study--called SPECTacl (Spectroscopic Assessment of Coronary Lipid)--is designed to validate the ability of the InfraReDx system to identify distinctive near-infrared spectra in patients. To interpret the significance of the spectra obtained in the SPECTacl study, a parallel study is being performed on autopsy specimens in which a histologic gold standard is available.

InfraReDx recently closed a U.S.$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 start 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.



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