The LipiScan IVUS coronary imaging system from InfraReDx (Burlington, MA) combines co-registered, grayscale, 40 MHz intravascular ultrasound (IVUS) with proprietary near infrared (NIR) lipid core plaque (LCP) detection technology to identify lipid-core plaques, degree of stenosis, reference vessel diameter, and plaque burden. It also facilitates proper stent sizing and placement, and verifies full stent expansion and apposition. It obtains IVUS images and NIR spectroscopy Chemograms simultaneously, which are available immediately upon conclusion of the imaging pullback procedure. Dual 19-in. LCD touch-screen monitors offer viewing angles in all lighting conditions.
InfraReDx’s New LipiScan™ IVUS Coronary Imaging System to Be Highlighted at TCT 2010
– Interventional Cardiology Community Thought Leaders to Discuss Clinical Experience with LipiScan to Improve Stenting Safety and Patient Outcomes –
BURLINGTON, Mass. – September 17, 2010 – InfraReDx, Inc., a medical device company developing intelligent cardiovascular diagnostic imaging technologies, today announced that its new LipiScan™ IVUS Coronary Imaging System will be highlighted during the annual Transcatheter Cardiovascular Therapeutics meeting (TCT 2010). The novel device, which was recently cleared by the U.S. Food and Drug Administration (FDA), will be featured in scientific and clinical symposia, live case broadcasts, product demonstrations and poster abstract sessions. TCT 2010 is being held September 21-25, 2010 at the Walter E. Washington Convention Center (“the convention center”) in Washington, D.C. TCT is the world's largest educational meeting specializing in interventional cardiovascular medicine and showcasing the latest advances in techniques, therapies and clinical research.
The Company expects to conduct a broad commercial launch of the system within the U.S. by year-end 2010, and anticipates regulatory approval and launch in Europe during 2011.
The LipiScan IVUS system utilizes a novel multimodality imaging catheter; the first ever to combine the complementary technologies of near-infrared (NIR) spectroscopy and intravascular ultrasound (IVUS). This combination enables interventional cardiologists to rapidly determine both the structure of plaque (via IVUS) along with its chemical composition (via NIR spectroscopy). NIR spectroscopy is the only technology cleared by the FDA for the specific task of detection of lipid-core coronary plaques (LCP). Such plaques can adversely impact the safety of stenting and are associated with heart attacks that occur in those who have received stents and in the general population.
Dr. James Muller, founder and chief executive officer of InfraReDx, Inc. noted that the “LipiScan IVUS system is the culmination of a major effort to develop a single catheter that utilizes both light and sound to characterize coronary plaques. The novel near-infrared spectroscopic feature is an excellent means to identify lipid core plaque while the traditional ultrasound provides a picture of the plaque that is useful for stenting decisions.”
Dr. Muller stated that “this new multimodality imaging system will provide the interventional cardiologist with additional information about the extent of atherosclerosis within the coronary artery that will help assess the level of risk of stenting procedures. We are pleased to present this breakthrough technology at TCT, the annual meeting for discussion of major advances in interventional cardiology.”
The LipiScan IVUS system will be featured in many sessions at TCT 2010.
I. Hands-on Product Education and Training
InfraReDx will host education, hands-on training and live demonstrations of the company’s LipiScan IVUS system in the Exhibit Hall at the InfraReDx booth #1800 on Thursday (9:00 a.m. to 5:00 p.m.), Friday (9:00 a.m. to 5:00 p.m.) and Saturday (9:00 a.m. to 2:00 p.m.). InfraReDx will also participate in the Nurse Tech Symposium held in conjunction with TCT on Tuesday, September 21.
II. Breakfast Symposium
InfraReDx will host a satellite symposium titled “Novel Multimodality Intracoronary Imaging to Improve Decision-Making, Stenting Safety and Prediction of Outcomes.” This hour-long breakfast panel event will begin Thursday, September 23 at 7:00 a.m. in Room 144B of the convention center.
The breakfast symposium will be chaired by James A. Goldstein, M.D., of William Beaumont Hospital in Royal Oak, Mich. A panel of renowned interventional cardiologists will present their perspectives on topics such as: the importance of identifying plaque composition, the clinical applicability of detecting vulnerable plaque, multimodality imaging technologies, determination of optimal stent length, and the detection and management of lesions at risk for distant embolization. Instructive clinical cases utilizing the LipiScan IVUS coronary imaging system to guide PCI will be presented and discussed.
The breakfast panel faculty includes: Emmanouil S. Brilakis, M.D., Ph.D.; Simon Dixon, M.D., Ph.D.; David G. Rizik, M.D.; Patrick W. Serruys, M.D., Ph.D. and Gregg W. Stone, M.D. A webcast of this symposium will be available on the InfraReDx website after the close of TCT 2010.
III. “Live Case” Demonstrations
At least two live case demonstrations of the LipiScan IVUS system are scheduled to be broadcast to the Main Arena of the convention center on Thursday, September 23 and Friday, September 24 (see the TCT 2010 onsite schedule for specific times). The operators for these real-time PCI procedures include:
Giora Wiesz, M.D. and Dr. Jeffrey W. Moses, M.D., from the New York-Presbyterian Hospital at Columbia University Medical Center in New York.
John L. Petersen, M.D., Mark Reisman, M.D. and Amish J. Desai, M.D. from the Swedish Medical Center in Seattle.
Demonstrations of the LipiScan IVUS system can also be viewed in the Exhibit Hall area, at the InfraReDx exhibit booth #1800.
IV. Scientific Symposia
The LipiScan system will be discussed in multiple sessions of the scientific program titled “Vulnerable Plaque: Emerging Directions for Diagnosis and Treatment” which takes place on Tuesday, September 21, 8:00 a.m. to 6:00 p.m., in Room 204ABC at the convention center. Highlights of this program include:
A discussion by Evelyn S. Regar, M.D., Ph.D., of the Erasmus Medical Center in Rotterdam, Amsterdam, entitled “A Combined IVUS-NIR Spectroscopy Catheter: Development and Clinical Cases,” during the “Invasive Imaging” session (V).
A presentation by Emmanouil S. Brilakis, M.D., Ph.D., of the Southwestern Medical Center in Dallas, entitled “Case Studies with NIR Spectroscopy,” during the “Case Studies in Vulnerable Plaque” session (VI).
A presentation by Gregg W. Stone, M.D., of the New York-Presbyterian Hospital at Columbia University Medical Center in New York, entitled “Rationale and Design of the VERDICT and CANARY Studies,” during the “Clinical Studies” session (VI). CANARY (Coronary Assessment by Near-Infrared of Atherosclerotic Rupture-prone Yellow) refers to a trial that InfraReDx plans to begin before year-end 2010 to test the hypothesis that LipiScan NIR-guided use of a distal protection device can prevent peri-procedural myocardial infarction (MI) caused by LCPs in patients undergoing PCI.
V. Concurrent Sessions
The LipiScan system will be a subject of discussion during a program titled “Next Generation Intravascular Imaging: OCT and NIR,” scheduled for Friday, September 24, 2:00 p.m. to 6:00 p.m., in Room 151AB at the convention center. Highlights of this program include:
A lecture by Dr. James E. Muller, founder and CEO of InfraReDx. Dr. Muller will present “Making Sense of Near-Infrared Spectroscopy: What Does it Detect and How?” during the “Technology Update” session (I).
A lecture by Brijeshwar Maini. M.D., of Pinnacle Health and Vascular Institute in Harrisburg. Dr. Maini will present “Use of NIR Spectroscopy to Risk-Stratify and Guide PCI Procedure” during the “Guiding Percutaneous Coronary Interventions” session (III).
Three case presentations during the “OCT and NIR Case Presentations” session (IV): “NIR Spectroscopy and Distal Embolization“; “NIR Spectroscopy and Stent Thrombosis”; and “Novel Insight from NIR Spectroscopy.” Presenters include: James A Goldstein, M.D., of William Beaumont Hospital in Royal Oak, Mich., David G. Rizik, M.D., of the Scottsdale Heart Group and Emmanouil S. Brilakis, M.D., Ph.D., of the Southwestern Medical Center in Dallas.
VI. Poster Abstract Sessions
Poster abstracts will be on view on Wednesday, September 22, 1:30 p.m. to 3:30 p.m., on the Lower Level of the convention center. On display will be two posters featuring NIR spectroscopy using the LipiScan imaging system, both of which have been accepted for publication in the Journal of American Cardiology (JACC).
Brugaletta S, et al. “Correlation Between Near-Infrared Spectroscopy and Intravascular Ultrasound with Virtual Histology in the Evaluation of Coronary Atherosclerosis: A Single Center Experience.” (Abstract poster TCT-350)
Madder RD, et al. “Frequency of Lipid-Core Plaque in Culprit and Non-Culprit Lesions by Intracoronary Near-Infrared spectroscopy.” (Abstract poster TCT-355)
The LipiScan system will also be highlighted on the final day of the meeting, during the Cardiovascular Imaging segment of the program titled “Top TCT 2010 Lessons and A Lens to the Future!” This wrap-up session takes place on Saturday, September 25, 3:00 p.m. to 5:00 p.m.
About the LipiScan™ IVUS Coronary Imaging System
The LipiScan IVUS Coronary Imaging System is the world’s only intravascular imaging system that combines co-registered grayscale intravascular ultrasound (IVUS) together with InfraReDx’s proprietary near infrared (NIR) lipid core plaque (LCP) detection technology. The LipiScan IVUS system delivers all the benefits of IVUS plus the lipid core plaque detection power of NIR spectroscopy to help physicians optimize their stenting strategy. The system was designed by cardiologists for cardiologists and provides an unparalleled "one-stop" visual determination of critical coronary health features to assist in the care of coronary patients, including the identification of lipid-core plaques, degree of stenosis, reference vessel diameter, and plaque burden. This information also aids in facilitating proper stent sizing and placement, and in verifying full stent expansion and apposition and may also help guide post-intervention medical therapy. The innovative design enables cardiologists to generate and display the combined Chemogram™/IVUS analysis immediately upon completion of the single catheter pullback.
Coronary Stenting Statistics
Each year, more than 2 million individuals worldwide undergo coronary stenting. While clinical results of stenting procedures have steadily improved, approximately 30% of individuals undergoing stenting experience a significant adverse event such as peri-stenting myocardial infarction, post-procedure complications from the stented site, or new coronary events at non-stented sites. In most cases, stenting is guided primarily by X-ray angiography, which does not reveal the health of the vessel wall. Increasingly, physicians are recognizing the limitations of relying on angiography alone and are turning to advanced imaging solution systems to optimize stenting strategy.
About InfraReDx, Inc.
InfraReDx, Inc. is a privately funded medical device company improving patient care through the development and commercialization of intelligent imaging technologies to improve the diagnosis and treatment of coronary artery disease. InfraReDx’s LipiScan™ IVUS Coronary Imaging System is the first and only available catheter to combine both near-infrared spectroscopy (NIR) and intravascular ultrasound (IVUS) technologies to both visualize and characterize the vulnerable intracoronary lipid core plaque (LCP) suspected of causing the majority of heart attacks. Founded in 1998, InfraReDx is headquartered in Burlington, Massachusetts. For more information, visit www.infraredx.com.
Posted by Lee Mather
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