Infraredx has announced the Makoto intravascular imaging system, and accompanying Dualpro intravascular ultrasound and near-infrared spectroscopy (IVUS+NIRS) catheter, is now available in Japan. The launch follows a Spring 2018 limited market release, which included more than 10 hospitals in Japan.
A press release states that the Makoto intravascular imaging system and Dualpro catheter is the only technology on the market to identify vessel structure and plaque composition using IVUS+NIRS. Its launch follows market approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in August 2017.
Dualpro is the only imaging catheter on the market equipped with extended bandwidth IVUS technology. By emitting and carefully processing a broad band of frequencies, the Dualpro IVUS is designed to provide the best-in-class image resolution without compromising depth of field. Data collected from the NIRS technology are translated into a Chemogram, which the press release describes as an easy-to-interpret, colour-coded map to identify lipid core plaque (LCP) that can help distinguish between stable plaque and dangerous LCP. Coupled together, IVUS+NIRS aims to give cardiologists with unparalleled insights into the role LCP plays in heart disease.
There are several global landmark studies—including the Lipid-Rich Plaque (LRP) study, currently underway—which underscore the importance of identifying LCP for the prediction, and ultimately prevention, of serious heart attacks. Results of the prospective, multicentre LRP study, along with a US market launch of the Makoto imaging system and Dualpro IVUS+NIRS catheter, are anticipated in 2H 2018. The technology is currently the only FDA-cleared dual-modality catheter and imaging system indicated for the detection of LCP.
Takashi Kubo (Wakayama Medical University, Wakayama, Japan), says: “In Japan, we rely heavily on intravascular imaging during percutaneous coronary intervention; so much so that is has become the standard of care, with approximately 90% of angioplasty procedures employing intravascular imaging. The Makoto Imaging System and Dualpro catheter is the next generation of imaging technology, providing superior deliverability and lesion crossing ability as well as best-in-class image resolution to easily identify the degree of stenosis and plaque burden.”
Jason Bottiglieri, president and CEO, says: “Infraredx is proud to announce the release of the Makoto intravascular imaging system and Dualpro IVUS+NIRS catheter in Japan, the world’s largest imaging market. IVUS+NIRS technology has the potential to dramatically change the field of interventional cardiology. Two unique modalities in one catheter provide cardiologists twice the information of other imaging catheters, helping to inform personalized treatment decisions. We thank our parent company Nipro for its significant role in advancing our commitment to the diagnosis and management of coronary artery disease.”