WASHINGTON & BURLINGTON, Mass.--(BUSINESS WIRE)--
MedStar Heart Institute of Washington, D.C. and Infraredx,
Inc., a medical device company committed to advancing the diagnosis
and management of coronary artery disease, today announced the
enrollment of the first participant in the Lipid-Rich Plaque (LRP)
Study, a prospective, multi-center study aimed at identifying a
correlation between LRPs, a particular type of fatty coronary artery
plaque, and the occurrence of a cardiac event within two years. LRPs,
which are implicated in most heart attacks, will be identified in study
participants using the Infraredx TVC Imaging System™, a first-in-class
dual modality intravascular imaging catheter.
MedStar Heart Institute, one of the 100 clinical sites worldwide to
participate in the trial, is a national leader in the research,
diagnosis and treatment of cardiovascular disease, and consistently
recognized by U.S. News & World Report and The Society of
Thoracic Surgeons as one of the top heart hospitals in the nation.
“We are pleased to announce the start of enrollment for this major
international study testing the ability of near-infrared spectroscopy
(NIRS) to detect the cholesterol-rich plaques suspected of causing heart
attacks,” said James Muller, MD, co-founder and chief medical officer of
Infraredx. “The decision to undertake this important study was based on
a wealth of data stemming from decades of research and development by a
dedicated team of more than 100 engineers and clinical scientists. Once
completed, the LRP Study could redefine the role of intravascular
imaging and lay the groundwork for changing standard protocol for
managing coronary artery disease.”
The TVC Imaging System integrates NIRS to detect lipid-core plaques, and
enhanced intravascular ultrasound (IVUS) to visualize the vessel
structure, including the presence of plaques and the degree of stenosis
(narrowing). The system identifies plaques suspected to be vulnerable to
rupture, which can cause a fatal coronary blockage. Current methods of
diagnosing coronary artery disease are limited in their ability to
detect such plaques.
Coronary artery plaques are caused by the build-up of cholesterol and
other materials inside the walls of the coronary arteries. Previous
studies have demonstrated that NIRS imaging in patients can identify
cholesterol-rich plaques that have caused a heart attack or cardiac
arrest. In a heart attack study1 published in the Journal
of the American College of Cardiology Cardiovascular Interventions,
researchers used NIRS imaging to detect a lipid-rich plaque at the
culprit site (site suspected to be the source of the heart attack) in 19
of the 20 patients studied. This important data was featured as one of Discover
magazine’s top 100 science stories of 2013.
“As a national leader in research and treatment of cardiovascular
disease, MedStar Heart Institute is proud to lead and enroll the first
participant in this potentially ground-breaking study,” said Ron
Waksman, MD, International Principal Investigator of the LRP Study, and
director of Cardiovascular Research and Advanced Education at the
MedStar Heart Institute. “The LRP Study could be the largest study to
use intravascular imaging to link suspected vulnerable plaques to a
higher risk of future coronary events. Successful identification of
vulnerable plaques could help clinicians better manage high-risk
patients and potentially prevent coronary events with the vast array of
currently available interventional devices.”
For more information on the LRP Study and enrollment sites and criteria,
please visit http://clinicaltrials.gov/ct2/show/NCT02033694
About The TVC Imaging System™
The TVC Imaging System™ is a first-in-class dual-modality 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 the risk of
peri-procedural heart attacks by assessing not only the degree of
stenosis, but also the presence and extent of lipid-core plaques (LCP).
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 specifically approved in both the U.S.
and Europe for the detection of LCPs. NIRS measurements have been made
in over 5,000 patients in over 100 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.
About MedStar Heart Institute
MedStar Heart Institute, headquartered at MedStar Washington Hospital
Center in Washington, D.C., is a national leader in the research,
diagnosis and treatment of cardiovascular disease, and has been the
premier destination for cardiac care in the nation’s capital for more
than 50 years. Consistently recognized for excellence by U.S.News &
World Report and The Society of Thoracic Surgeons, MedStar Heart
Institute entered into a first-of-its-kind clinical and research
alliance with world-renowned Cleveland Clinic Sydell and Arnold Miller
Family Heart & Vascular Institute in January 2013. Uniting two of the
nation’s top heart programs, this alliance enhances the
Baltimore-Washington metropolitan region’s access to advanced,
innovative cardiac care and research. MedStar Heart Institute comprises
more than 100 cardiac physician specialists throughout the mid-Atlantic
region, as well as the nationally recognized heart care of MedStarWashington Hospital Center, the academic depth of MedStar Georgetown
University Hospital, and the cardiac services of MedStar Montgomery
Medical Center, MedStar Union Memorial Hospital, MedStar St. Mary’s
Hospital and five other acute care hospitals.
1 Madder et al, JACC Interventions 2013)
Grant Frazier, 781-345-9632
President of Marketing
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Source: Infraredx, Inc.