Infraredx has launched Makoto Intravascular Imaging System and Dualpro intravascular ultrasound and near-infrared spectroscopy (IVUS+NIRS) catheter in Japan.
The launch follows a successful Spring 2018 limited market release, which included more than 10 hospitals in Japan.
Infraredx president and CEO Jason Bottiglieri said: “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.”
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 last year.
Wakayama Medical University Takashi Kubo said: “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.”
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 provides best-in-class image resolution without compromising depth of field.
Data collected from the NIRS technology are translated into a Chemogram, an easy-to-interpret, color-coded map to identify lipid core plaque (LCP), which can help distinguish between stable plaque and dangerous LCP. Coupled together, IVUS+NIRS arms 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, multi-center LRP Study, along with a US market launch of the Makoto Imaging System and Dualpro IVUS+NIRS catheter, are anticipated in second half of this year. The technology is currently the only FDA-cleared dual-modality catheter and imaging system indicated for the detection of LCP.
Source: Company Press Release