Infraredx Launches Makoto Intravascular Imaging System and Dualpro IVUS+NIRS Catheter in Japan
July 31, 2018—Infraredx, Inc., a Nipro company, announced the Japanese launch of the Makoto intravascular imaging system and accompanying Dualpro intravascular ultrasound and near-infrared spectroscopy (IVUS+NIRS) catheter for mapping coronary artery disease.
The launch follows a Spring 2018 limited market release that included more than 10 hospitals in Japan. In August 2017, the company received approval for the Makoto system and Dualpro catheter from Japan’s Pharmaceuticals and Medical Devices Agency.
According to Infraredx, the IVUS+NIRS technology combines the two modalities in one catheter to identify vessel structure and plaque composition, providing cardiologists twice the information to help inform personalized treatment decisions.
Dualpro is equipped with extended bandwidth IVUS technology that emits and carefully processes a broad band of frequencies. Data collected from the NIRS technology are translated into a chemogram, an easy-to-interpret, color-coded map to identify lipid core plaque, which can help distinguish between stable plaque and dangerous lipid core plaque.
Results of the prospective, multicenter Lipid-Rich Plaque Study, along with the United States market launch of the Makoto imaging system and Dualpro IVUS+NIRS catheter, are anticipated in 2018. The imaging system with the dual-modality catheter is FDA-cleared for the detection of lipid core plaque.
Takashi Kubo, MD, from Wakayama Medical University in Wakayama, Japan, commented in the company's announcement, “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.”