Large-Scale Study in Patients with Acute Coronary Syndrome Builds on the Success of Landmark PROSPECT Study that Identified Plaques at Risk of Causing Future Coronary Events

BURLINGTON, Mass. - Infraredx, Inc., a medical device company committed to advancing the diagnosis of coronary artery disease and prevention of heart attacks, today announced the first patient enrolled in PROSPECT II, a multi-center, prospective study designed to assess the ability of intravascular imaging to identify non-flow obstructing vulnerable plaques. Lipid core plaque (LCP), which is suspected to be vulnerable plaque, is a type of fatty coronary artery plaque implicated in most heart attacks, and will be identified using the Infraredx TVC Imaging System™, a first-in-class dual modality intravascular imaging system. The study's first patient was enrolled by David Erlinge, MD, PhD, one of the study's principal investigators, from Lund University in Sweden.

The TVC Imaging System is the only device approved by the FDA to detect the presence of LCPs. The technology integrates near-infrared spectroscopy (NIRS) to detect LCPs, with enhanced intravascular ultrasound (IVUS) to visualize the vessel structure, and is used to guide percutaneous coronary interventions (PCI). Approximately 2 million patients undergo PCI each year in the U.S. and Europe.
"There is mounting clinical evidence pointing to the role of lipid-rich plaque as the main cause of heart attacks," said Dr. Erlinge. "The PROSPECT II study will allow us to test our hypotheses that NIRS-IVUS imaging can identify the vulnerable plaques that cause heart attacks, and that preemptive treatment of the most dangerous plaques with PCI can prevent the development of further narrowing of the coronary arteries, as well as plaque erosion and rupture."

Infraredx will provide the primary funding for the study, with additional support from The Medicines Company and Abbott Vascular.

In 2011, the New England Journal of Medicine published results from the original PROSPECT study, which was the first to prospectively demonstrate that vulnerable plaques can be identified through imaging techniques months to years before adverse events occur. The PROSPECT II study, which will enroll 900 patients at 16 leading cardiac catherization laboratories across Scandinavia, will use the TVC Imaging System to identify vulnerable plaques in the three major coronary arteries and follow patients for at least three years to detect the occurrence of coronary events. In addition, 300 patients with "bulky" plaques (detected by intravascular ultrasound), which have been shown to be at high risk for causing future adverse events in the first PROSPECT study,1 will be randomly assigned to treatment with Abbott's Absorb™ Bioresorbable Vascular Scaffold (BVS) or optimal medical therapy.

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