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Infraredx receives regulatory approval of TVC Imaging System in Japan

Infraredx, a medical device company, announced that its first-in-class, dual-modality intravascular imaging technology, TVC Imaging System, and its TVC Insight Catheter received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW).

The TVC System makes it possible to determine the structure and chemical composition of the coronary plaques that complicate stenting, and are associated with heart attacks. The TVC Imaging System console and catheter will be exclusively distributed by Goodman, a subsidiary of Osaka-based Nipro Corporation, which has extensive experience commercializing IVUS and other imaging technologies in Japan.

The TVC Imaging System integrates near-infrared spectroscopy (NIRS) to detect lipid-core plaques and enhanced intravascular ultrasound (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 TVC Imaging System can identify plaques suspected to be vulnerable to rupture, which can cause a heart attack.

"The approval to market the TVC Imaging System in Japan marks an important milestone in our Asia-Pacific commercial expansion strategy, and we thank our partner Nipro for their instrumental role in advancing our regulatory and commercialization efforts in Japan," said Don Southard, president and chief executive officer of Infraredx.

"By combining NIRS and IVUS, two proven intravascular imaging modalities, the TVC Imaging System has the potential to add tremendous clinical value in the Japanese market, where the use of intravascular imaging during interventional coronary procedures is the standard of care."

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

The device is the only commercially available multimodality imaging system to combine both intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS). Through IVUS technology, the TVC Imaging System provides clear and relevant information about vessel structure in real time.

The TVC Imaging System is the only commercially available device approved in both the U.S. and Europe, and now Japan, for the detection of LCPs. NIRS measurements have been made in over 12,000 patients in over 100 hospitals worldwide.