News | Intravascular Imaging | August 10, 2018

Infraredx Announces Japanese Launch of Makoto Intravascular Imaging System and Dualpro IVUS+NIRS Catheter

Dual-modality intravascular imaging system saw limited market release in spring 2018

 

Infraredx Announces Japanese Launch of Makoto Intravascular Imaging System and Dualpro IVUS+NIRS Catheter

August 10, 2018 — Infraredx Inc. 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 successful Spring 2018 limited market release, which included more than 10 hospitals in Japan.

The Makoto Intravascular Imaging System and Dualpro catheter is the only technology on the market, according to Infraredx, 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.

“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 percent of angioplasty procedures employing intravascular imaging,” said Takashi Kubo, M.D., Ph.D.., Wakayama Medical University. “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.”

According to Infraredx, Dualpro is the only imaging catheter on the market equipped with extended bandwidth IVUS technology. By emitting and processing a broad band of frequencies, the Dualpro IVUS provides high 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.

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 U.S. market launch of the Makoto Imaging System and Dualpro IVUS+NIRS catheter, are anticipated in the second half 2018. The technology is currently the only U.S. Food and Drug Administration (FDA)-cleared dual-modality catheter and imaging system indicated for the detection of LCP.

For more information: www.infraredx.com

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Angiography shows a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

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