Medical device maker Infraredx (Burlington, MA) has received a $25 million equity investment from Nipro Corporation (Osaka, Japan), which builds on an exclusive agreement between the two companies for distribution of Infraredx's TVC Imaging System in Japan, the world's largest intravascular imaging market. In conjunction with the investment, a member of Niproâs management team will join Infraredx's board of directors.
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The TVC Imaging System is an intravascular imaging system that integrates near-infrared (NIR) spectroscopy lipid core plaque (LCP) detection and intravascular ultrasound (IVUS) imaging technology to assess vessel composition and structure.
|Infraredx's TVC Imaging System. (Image courtesy of Infraredx)|
For the past year, the company has been working with Nipro to secure regulatory approval and launch the system in Japan, according to Donald Southard, president and CEO of Infraredx. Proceeds from the investment will be used to support the companyâs expansion, operations, and commercialization of the system in Japan, and the two companies are on track to receive Japanese regulatory approval of the system in the first half of 2014.
Intravascular ultrasound imaging is the standard of care in Japan, with more than 80 percent of all percutaneous coronary intervention (PCI) procedures guided by intravascular imaging. However, while intravascular ultrasound can reveal the structure of a vessel and the presence of plaque, it is not an optimal method to determine plaque composition and whether it contains a lipid core. Lipid core plaque (LCP) is a fatty coronary artery plaque suspected to be vulnerable to rupture and cause most heart attacks It can also complicate stenting procedures, and new studies indicate that LCP is present within the culprit lesion of a high number of patients with ST-Elevation Myocardial Infarction, a dangerous type of heart attack. The TVC Imaging System is the only device that offers physicians both NIR spectroscopy to detect LCP combined with intravascular ultrasound for true vessel characterization.
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