Infraredx receives Japanese regulatory approval for multimodal intravascular imaging system

Coronary artery disease medical device maker Infraredx (Burlington, MA) has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW; Tokyo, Japan) for the company's TVC Imaging System and TVC Insight Catheter, a multimodal technology for intravascular imaging. The system makes it possible to determine the structure and chemical composition of coronary plaques that complicate stenting and are associated with heart attacks. The system console and catheter will be exclusively distributed by Goodman, a subsidiary of Nipro Corporation (Osaka, Japan), which has experience commercializing intravascular ultrasound (IVUS) and other imaging technologies in Japan.

The system integrates near-infrared spectroscopy (NIRS) to detect lipid-core plaques and enhanced IVUS to visualize vessel structure, including the presence of plaques and the degree of stenosis (narrowing) due to plaque build-up. Lipid core plaque is a fatty coronary artery plaque associated with most heart attacks. The system can identify plaques suspected to be vulnerable to rupture, which can cause a heart attack.

Infraredx entered a partnership with Nipro in August 2013, when it received an initial $25 million equity investment. Goodman, now a partially owned subsidiary of Nipro, has a history in the cardiovascular market as a distributor, establishing IVUS system market leadership for Boston Scientific and later for Volcano Corporation in Japan.


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