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Catheter combines near-infrared spectroscopy with IVUS
New device detects and assesses the intracoronary composition of lipid core plaque.
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The first multimodality coronary imaging catheter has recently received 510(k) clearance from the FDA.
The LipiScan IVUS Coronary Imaging System (InfraReDx) device is the result of 10 years of research and more than $100 million in development. Currently, the company is planning a broad commercial launch of the system within the U.S. by the end of 2010 and expects regulatory approval and launch in Europe during 2011.
The catalyst for the development, according to James E. Muller, MD, company founder and CEO, was discussions with cardiology leaders.
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Photo courtesy of: InfraReDx |
“They told us the near-infrared data was very interesting, but it was floating in air as a series of chemical measurements made within the artery without any direct relationship to the side branches or the plaque itself — there was no picture of the plaque,” Muller said. “They urged us to combine it with a structural method.”
This combination utilizes IVUS and near-infrared spectroscopy to interrogate the artery and determine the structure and chemistry of the plaque. LipiScan IVUS is able to generate and display the combined chemogram/IVUS analysis immediately upon completion of the single catheter pullback.
For Emmanouil Brilakis, MD, director of the cardiac catheterization laboratory at the VA North Texas Health Care System in Dallas, who has used the catheter in 200 to 300 cases so far, “The device has been easy to use and deliver. It’s similar to the IVUS catheter and has the same risk for complications, which is very low.”
A recent study published in the Journal of the American College of Cardiology provided a look at the first-in-man clinical application of the device. The catheter was used in a 57-year-old man who had a previous MI and primary stenting of the right coronary artery and demonstrated lipid-rich plaque extending almost 270· of the vessel circumference. According to study researchers, direct stenting obtained an excellent angiographic result. After the procedure, the patient experienced mild transient chest discomfort without electrocardiographic changes, but cardiac enzymes were elevated.
The future goals for the device, according to Muller, involve preventing MI caused by stenting, as well as MI that occurs after stenting.
“Someday, together with a noninvasive screening measure which might be CT, we hope the LipiScan IVUS will contribute to a preventive strategy to prevent the first MI,” he said.
Regarding what the physician can expect as an immediate advantage, Brilakis said: “Having the combination of IVUS and spectroscopy in one catheter will help a lot because you can get all the information at once, and then you can see exactly where the lipid is in relationship to anatomic landmarks, and optimize the treatment plan. This will save about 5 to 10 minutes, which in a busy cath lab, can add up to a significant amount of time and can also help reduce the risk for percutaneous coronary intervention-related complications.” – by Brian Ellis
Schultz C. J Am Coll Cardiol. 2010;56;314.