Infraredx, a cardiovascular imaging company, has received 510(k) clearance from the US Food and Drug Administration (FDA) to expand the indications for use for its Makoto intravascular imaging system.
Infraredx is owned by the Japan-based company Nipro and is focused on intravascular imaging for mapping coronary artery disease.
The FDA approval is based on the outcome of the landmark Lipid-Rich Plaque (LRP) Study, which revealed the ability of intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) technology to identify patients and coronary plaques at an increased risk for major adverse cardiac events (MACE).
The LRP study enrolled 1,563 patients from 44 sites across the US and Europe.
Leveraging IVUS+NIRS technology, the study will evaluate patient and plaque lipid core burden index (LCBI) in stable and unstable patients requiring an angiogram procedure for new or ongoing cardiac symptoms.
Infraredx president and CEO Nozomu Fujita said: “We are very proud of this new milestone that expands the indication for use of the Makoto Imaging System and accompanying Dualpro IVUS+NIRS catheter to detect both plaques and patients at high risk for dangerous cardiovascular events.
“IVUS+NIRS imaging has the power to transform the imaging world as we know it and we hope that its use will help predict and prevent heart attacks.”
LCBI is validated as a quantitative summary metric of the lipid core in a scanned or selected region.
Using NIRS, the system can detect lipid core plaque (LCP) and automatically displays the results through a simple, color-coded map, known as a chemogram. It can also generate LCBI calculations and the chemogram automatically, which displays the presence of LCP in yellow and absence in red.
The company said that the results of the study revealed at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) conference showed that patients with a maximum LCBI value of any 4mm section of a scanned or selected region (maxLCBI4mm) greater than 400 were at 87% higher risk of non-index culprit lesion related MACE than a patient with a lesser maxLCBI4mm.
The study results also found that the risk of non-index culprit lesion related MACE in a coronary segment with a maxLCBI4mm greater than 400 is more than 4-fold higher than in a segment with a lesser maxLCBI4mm.
MedStar Heart Institute cardiology division associate director and the LRP Study principal investigator Ron Waksman said: “These expanded FDA label claims are evidence based on the NIRS imaging technology that was demonstrated in the landmark Lipid-Rich Plaque Study.
“The study demonstrated that NIRS imaging can identify both patients and non-culprit lesions at risk for subsequent events.
“These label claims are an important and exciting milestone for the technology and the physicians who have access to the NIRS technology. This carries important information for patients and physicians.”
In 2018, Infraredx has launched the Makoto Imaging System in Japan and is expected to continue the expansion of its business into the US and EU markets.