Infraredx Receives Regulatory Approval of TVC Imaging System in Japan

Infraredx Inc.’s first-in-class, dual-modality intravascular imaging technology, TVC Imaging System, and its TVC Insight Catheter have 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 role in advancing our regulatory and commercialization efforts in Japan,” said Don Southard, president/CEO of Infraredx. “By combining NIRS and IVUS, 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.”

More than 200,000 IVUS procedures were performed in Japan in 2014, and the country makes up 50 percent of the worldwide intravascular imaging market, according to Infraredx. The use of IVUS to guide percutaneous coronary intervention (PCI) is the standard of care in Japan, with use in more than 80 percent of all procedures. While IVUS can reveal the structure of a vessel and the presence of plaque, it is not the optimal method to determine if the plaque contains a cholesterol rich lipid core. The TVC Imaging System is the only commercially available device approved in both the U.S. and Europe, and now Japan, to visualize both vessel structure and provide lipid core data, the company claims.

“Approval and introduction of the advanced TVC Imaging System into Japan is welcome news for Japanese interventional cardiologists,” said Takashi Akasaka, M.D., professor of medicine at Wakayama Medical University. “In Japan, cardiologists’ use of IVUS to guide percutaneous coronary interventions is standard practice, and integration of NIRS lipid core data with grayscale IVUS will provide a more comprehensive view of vessel structure, degree of stenosis and plaque composition. This combined data will enable physicians to make more informed treatment decisions and provide more effective patient management.”

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

The TVC Imaging System is a first-in-class intravascular imaging system that can change the management of coronary artery disease by providing information that is critical for evaluating vessel structure and composition, also known as true vessel characterization. The TVC Imaging System helps interventional cardiologists identify which patients are prone to complications during stenting. The device enables cardiologists to predict the risk of peri-procedural heart attacks by assessing not only the degree of stenosis, but also the presence and extent of lipid core plaques (LCP).

Infraredx is a privately funded cardiovascular imaging company. It was founded in 1998 and is headquartered in Burlington, Mass.