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Infraredx Gains Approval in Japan for Its NIRS/IVUS Coronary Imaging System
TVC Imaging System Currently Only FDA-Approved Device for Imaging Large Lipid Core Plaques
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The Lipid-Rich Plaque Study (LRP)

Infraredx, Inc.

Infraredx TVC Image
Infraredx TVC Image
September 30, 2014 -- Yesterday, Infraredx announced that they have received approval in Japan for their TVC Imaging System, the only FDA-approved device to visualize and identify the large lipid core plaques that are thought to be most likely to cause a heart attack. Japan makes up 50% of  the worldwide intravascular imaging market. 

The company, which has partnered with the Japanese firm Nipro, sees this approval as a significant milestone in their expansion strategy. Last August, Infraredx received an initial $25 million equity investment from Nipro. Furthermore, Goodman, which has had a successful history in the Japanese cardiovascular imaging market as a distributor, establishing IVUS system market leadership for Boston Scientific and later for Volcano Corporation, is now a partially owned subsidiary of Nipro.

Japan, in particular, has been a strong market for intravscular imaging, specifically intravascular ultrasound (IVUS) because the healthcare system reimburses IVUS imaging, based on a determination that IVUS improves outcomes in stent procedures. Infraredx's hybrid near-infrared-spectroscopy (NIRS) and IVUS system takes that imaging to the next level.

Ron Waksman, MD
Ron Waksman, MD

A major international trial, the Lipid-Rich Plaque Study (LRP) is currently enrolling patients to see if the so-called "vulnerable plaque" identified by the Infraredx technology is linked to a higher risk of future coronary events.

The Lipid-Rich Plaque (LRP) Study, headed up by Dr. Ron Waksman, director of Cardiovascular Research and Advanced Education at the MedStar Heart Institute in Washington, DC, will involve 100 centers worldwide, has a target enrollment of 9,000 patients and is expected to take almost five years to complete, with final data collection estimated for December 2018.

Monday's press release from Infraredx follows:

Infraredx Receives Regulatory Approval of TVC Imaging System in Japan

September 29, 2014 -- Burlington, MA -- Infraredx, Inc., a medical device company committed to advancing the diagnosis and management of coronary artery disease, today 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."

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. 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.[1] 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.

"Approval and introduction of the advanced TVC Imaging System into Japan is welcome news for Japanese interventional cardiologists," stated Dr. Takashi Akasaka, 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 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.

About The TVC Imaging System™
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).

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.

About Infraredx, Inc.
Infraredx, Inc. is a privately funded medical device company dedicated to helping provide practitioners with the information needed for enhanced clinical decision making in treating coronary artery disease. The company is committed to improving the safety and efficacy of coronary stenting and ultimately serving as part of a strategy to prevent initial coronary events.

Through its TVC Imaging System™, Infraredx is changing the way coronary artery disease is diagnosed and treated by enabling true vessel characterization through simultaneous structural and compositional imaging data obtained in a single pullback. Founded in 1998, Infraredx is headquartered in Burlington, Mass. For more information, visit

[1] Millennium Research Group.  Japanese Markets For Interventional Cardiology Devices 2013.

Reported by Burt Cohen, September 30, 2014