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BURLINGTON, Mass. – July 17, 2013 – Infraredx, Inc., a medical device company committed to advancing the diagnosis and management of coronary artery disease, today announced the publication of key data supporting the ability of its TVC Imaging System to detect lipid core plaque in patients with ST-Segment Elevation Myocardial Infarction (STEMI). The study, published in JACC: Cardiovascular Interventions, details the identification of a specific cholesterol signature by Near Infrared Spectroscopy (NIRS) at the site of the culprit lesions causing STEMI, a dangerous type of heart attack. While the TVC Imaging System has been used in more than 3,000 patients worldwide, the present study is the first report of its use in a consecutive series of STEMI patients.
The research was led by Ryan D. Madder, M.D., a practicing interventional cardiologist at Spectrum Health, in Grand Rapids, Mich. The study utilized the TVC Imaging System, which is a first-in-class intravascular imaging system that integrates near-infrared spectroscopy (NIRS) lipid core plaque detection and enhanced intravascular ultrasound (IVUS) imaging technology to assess vessel composition and structure.
“We have discovered a near-infrared spectroscopic signature of the plaques which cause myocardial infarction, a leading cause of morbidity and mortality worldwide,” said Dr. Madder. “This signature is detectable at the time of cardiac catheterization using a novel intracoronary imaging device. It is our hope that this signature may be capable of predicting a myocardial infarction before it happens. Through an international collaboration with several other centers, further studies are currently underway and others are being planned to validate this signature and to determine if near-infrared spectroscopy can accurately predict future myocardial infarction.”
In this study, researchers utilized the TVC imaging system to image the culprit vessel, as identified by angiography, in 20 STEMI patients referred acutely for primary percutaneous coronary intervention. In 19 of the 20 patients, a distinct signature of lipid core plaque (LCP) was identified with NIRS specifically at the location of the culprit lesion. To confirm plaque composition, the researchers compared the NIRS imaging results from the sites causing the blockage and subsequent heart attack to results from non-culprit segments of the patients’ vessels as well as to 46 autopsy specimens serving as the gold-standard of histology. The study’s novel in vivo findings of lipid core plaque at STEMI culprit sites correspond with multiple autopsy studies that have demonstrated that rupture of a large lipid core plaque is the most frequent cause of a fatal myocardial infarction. Most importantly for predictive and preventive purposes, it is likely that the large lipid core plaques observed at STEMI culprit sites were present and detectable before plaque rupture and thrombus formation and the acute coronary event.
“There are many possible treatments already available for coronary plaques at increased risk for rupture and thrombosis,” said James E. Muller, M.D., founder and chief medical officer of Infraredx. “The primary challenge cardiologists have faced has been the identification of plaques likely to cause major adverse events, including heart attacks. The identification of a clear signal so closely associated with culprit plaques in patients suffering STEMI is a major step forward in the effort to identify and treat vulnerable coronary plaques before they cause a catastrophic event.”
The paper, titled “Detection of Near-infrared Spectroscopy of Large Lipid Core Plaques at Culprit Sites in Patients with Acute ST-Segment Elevation Myocardial Infarction,” is now available online.
About ST-Segment Elevation Myocardial Infarction (STEMI)
Myocardial infarctions (heart attack) occur when a plaque ruptures and its contents are exposed to blood, creating a thrombus (blood clot) that, in turn, leads to a rapid, complete blockage of an artery. ST-Segment Elevation Myocardial Infarction (STEMI) is the more severe type of heart attack. In the United States alone, more than 1 million individuals experience a myocardial infarction or sudden cardiac death each year.[1]
About The TVC Imaging System™
The TVC Imaging System™ is a first-in-class intravascular imaging system that holds the potential to revolutionize the management of coronary artery disease by providing information that is critical for evaluating vessel structure and composition, also known as true vessel characterization. The TVC Imaging System helps interventional cardiologists identify which patients are prone to complications during stenting. The device enables cardiologists to predict peri-procedural heart attacks by assessing not only the degree of stenosis, but also the presence and extent of lipid-rich plaques (LRP).
The device is the only multimodality imaging system to combine both intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS). Through IVUS technology, the TVC Imaging System provides clear and relevant information about vessel structure, in real time. The TVC Imaging System is the only device available in both the U.S. and Europe for the detection of LCPs. NIRS measurements have been made in over 5,000 patients in over 90 hospitals worldwide.
About Infraredx, Inc.
Infraredx, Inc. is a privately-funded medical device company dedicated to helping provide practitioners with the information needed for enhanced clinical decision making in treating coronary artery disease. The company is committed to improving the safety and efficacy of coronary stenting and ultimately serving as part of a strategy to prevent initial coronary events.
Through its TVC Imaging System™, Infraredx is changing the way coronary artery disease is diagnosed and treated. The TVC Imaging System is the only intravascular imaging system that enables true vessel characterization through simultaneous structural and compositional imaging data obtained in a single pullback. Founded in 1998, Infraredx is headquartered in Burlington, Mass. For more information, visit www.infraredx.com.
Contacts:
Infraredx
Grant Frazier
Vice President of Marketing
Infraredx, Inc.
781-345-9632
gfrazier@infraredx.com
Susan Heins (media)
Pure Communications, Inc.
864-346-8336
sjheins@purecommunicationsinc.com
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