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LipiScan Intravascular Plaque Imaging System Receives FDA 510(k) Clearance

September 2nd, 2010 Justin Barad Cardiology

InfraReDx of Burlington, Mass just announced FDA clearance of their LipiScan IVUS Coronary Imaging System. Coronary angioplasty used to be based on the premise that areas of arterial narrowing seen on angiography were the most critical zones to stent, believing them to be the cause of heart attacks. Thinking has changed, however, and there is some research showing that plaques that may not cause much narrowing of the arteries may be the ones prone to rupture and thrombosis. This has led to a plethora of innovation in coronary imaging systems and technologies.
We reported in 2008 about InfraReDx’s near-infrared sprectroscopy coronary imaging system. The Lipiscan IVUS adds intravascular ultrasound to their device and is reportedly the first to combine intravascular ultrasound as well as near-infrared sprectroscopy to characterize intravascular plaques. The catheter-based system can be used during angioplasty to identify plaques that are likely to rupture and lead to a heart attack. It can also be used to predict stenting complications such as restenosis. Once stenting has been performed, IVUS can be used to analyze how effective a lesion has been stented.
Here is more from the press release:

The NIR spectroscopy identifies the chemical content of the plaques; the IVUS provides an image of plaque structure and stent features. 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.
David Rizik, M.D., medical director of Invasive Cardiology at Scottsdale Healthcare Shea Medical Center, commented, “Patients are increasingly presenting to the cath lab with complex lesions, such as left main disease, multi-vessel disease and bifurcation lesions. In these patients, angioplasty guided by angiography alone is inadequate to prevent potential complications such as restenosis, stent thrombosis, and peri-procedural myocardial infarction.” He continued, “To address these challenging cases, we have already incorporated the use of the original LipiScan system to help us identify lipid core plaques that complicate stenting. We are excited to acquire the next-generation LipiScan IVUS, as the addition of IVUS technology to the LipiScan platform will transform this novel diagnostic tool into a truly indispensible component of our lab.”

Press release: InfraReDx Receives FDA Clearance for LipiScan IVUS Coronary Imaging System…
InfraReDx homepage…

Justin Barad

Justin Barad is a board eligible pediatric orthopaedic surgeon. He did his fellowship at Boston Children's Hospital in the Harvard Combined Orthopaedic Surgery program and his residency at UCLA. He is also the Founder and CEO of Osso VR, a clinically validated surgical simulation platform. His interests include Virtual/Augmented Reality, robotics, surgical navigation and 3D Printing/Scanning, He is always looking to discuss the latest and greatest in medtech. He has been writing for Medgadget about medical technology since 2006 and also has several research publications and presentations.

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