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

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…