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Infraredx, a Nipro Company Announces FDA Approval of MakotoTM Intravascular Imaging System to Expand Efficiency Marking

Thursday, Apr 25, 2019

Infraredx, a Nipro Company is a pioneer in the field of intravascular imaging for coronary artery disease, the company announced today that the US Food and Drug Administration (FDA) 510(k) approval for the company's MakotoTM Intravascular Imaging System Extended Use Indications has been issued. The approval is based on a landmark fat-rich plaque (LRP) study that shows that patients with elevated risk of major cardiac adverse events (MACE) can be identified by intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) techniques. And plaques.

The study enrolled 1,563 patients in 44 research units in the United States and Europe, using IVUS+NIRS to assess stable and unstable patients and plaque fat cores requiring angiography for new or persistent cardiac symptoms. Burden Index (LCBI). Validate whether LCBI can be used as a quantitative generalized measure of fat core in a scan or selected area. The system uses NIRS to detect fat core plaques (LCP) and automatically display the results through a simple color map called chemogram. The system automatically generates LCBI calculations and chemograms, the latter showing LCP in yellow and LCP in red.

Results published at the 2018 Transcatheter Cardiovascular Therapy (TCT) meeting showed that maxLCBI 4mm (maximum LCBI for any 4 mm long segment in a scan or selected area) was greater than 400 in patients with non-index culprits The risk of MACE is 87% higher than patients with maxLCBI 4mm less than 400. In addition, the results of the study showed that in a coronary artery segment with a maxLCBI of 4 mm greater than 400, the risk of non-indexed lesion-related MACE was greater than 4 times that of maxLCBI 4 mm less than 400 segments.

Infraredx, a Nipro Company President and CEO Nozomu Fujita said: “We are very proud that this new milestone extends the use of the MakotoTM imaging system and the accompanying DualproTM IVUS+NIRS catheter for simultaneous use. Plaques and patients with elevated risk of cardiovascular risk events are detected. As far as we know, IVUS+NIRS imaging is expected to transform imaging, and we hope that its application can help predict and prevent heart attacks."

Ron Waksman, MD, deputy director of the Department of Cardiology at the MedStar Heart Institute, director of cardiovascular research and higher education at MedStar Cardiovascular Research, and MD, said: "The FDA approved the expanded efficacy label based on landmark lipid-rich spots. The NIRS imaging technology demonstrated by the block study shows that NIRS imaging can simultaneously identify patients at high risk for subsequent events and non-culprit lesions. This is an important and exciting indicator for the technology and the doctors who have access to NIRS technology. Milestones. This brings important information to patients and doctors."

Antonio Colombo, MD of the Maria Cecilia Hospital in Cotignola, Ravenna, Italy , also serves as the general coordinator of the GVM Hospital and Columbus Hospital in Milan. He said: "The Makoto imaging system is a major advancement in the field of coronary artery imaging. The system has been successfully applied and is gathering key insights from the chemogram information it provides. The information we receive from this system helps to make more personalized treatment decisions for my patients."

Gregg W. Stone, MD, director of cardiovascular research and education at Columbia University Medical Center and New York Cardiovascular Research Foundation/New York Presbyterian Hospital, and ongoing research on PROSPECT II, ??said: "FDA's new approval of NIRS for the heart The identification of patients with increased risk of major adverse events and plaque identification is a milestone achievement. Recent data suggest that the imaging technique can identify dangerous plaques that may suddenly progress, and these data will enable the development of new treatments, thereby Improve the prognosis of these high-risk patients."

Infraredx, a Nipro Company launched the MakotoTM imaging system in Japan in 2018 and will enter the US and EU markets.

About Infraredx, a Nipro Company

Infraredx, Inc., a Nipro Company is promoting the diagnosis and treatment of coronary artery disease by providing cardiologists with the most accurate imaging tools necessary to predict and ultimately prevent heart attacks. Infraredx is committed to promoting this important area of ??research and conducting milestone clinical trials to transform the way we recognize and treat heart disease. For more information on fat-rich plaque research, visit and follow Infraredx on Twitter and LinkedIn

Disclaimer: The original version of this announcement is an officially licensed version. The translation is for your convenience only. Please refer to the original text. The original version is the only legally valid version.

Kaidlyn Dmyterko
Marketing Communications Manager
Infraredx, a Nipro Company



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