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 infraredx.
InfraReDx
infraredx