FDA Clears First Coronary Catheter With Dual NIR/IVUS Technology

Yael Waknine

September 02, 2010

September 2, 2010 — The US Food and Drug Administration has granted 510(k) clearance for a next-generation catheter-based coronary imaging system (LipiScan IVUS; InfraReDx Inc) to help clinicians detect and also characterize lipid core coronary plaques (LCPs).

Built on the company's original near-infrared (NIR) spectroscopy (LipiScan NIR) platform, the 1-step cardiac catheter incorporates intravascular ultrasonography (IVUS) technology to provide clinicians with a grayscale image of the coronary artery along with a complete and coregistered chemogram — a map of LCPs within the imaged vessel.

This unique ability to characterize coronary plaque structure and composition can help guide stent placement and identify fatty plaques that complicate stenting procedures and are suspected to cause most postprocedural myocardial infarctions.

"[W]e are already successfully employing the LipiScan NIR system and gleaning key insights from the chemogram information it provides. The inclusion of plaque structure data via LipiScan IVUS further elevates the system's practical clinical utility for characterizing coronary lesions and identifying lipid core plaque," noted James Goldstein, MD, in a company news release. "This information can better inform technique and treatment decisions for my patients today, and, in the future, holds the promise to help prevent heart attacks and sudden death." 

Dr. Goldstein is director of Cardiac Research and Education for the William Beaumont Hospital in Michigan and has been involved in plaque-related research for more than a decade.

Use of the imaging system may also help to prevent other complications in patients who present with difficult complex lesions.

"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," explained David Rizik, MD, medical director of invasive cardiology at Scottsdale Healthcare Shea Medical Center in Arizona, in the news release. "[T]he addition of IVUS technology to the LipiScan platform will transform this novel diagnostic tool into a truly indispensible component of our lab." 

The company is planning "a broad commercial launch" of the dual NIR/IVUS system in the United States this year and anticipates European regulatory approval and launch in 2011. The original NIR system is currently in use at about 25 US cardiac centers.

Dr. Goldstein currently serves as a consultant to InfraReDx and other medical device and imaging technology services.


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