Nipro (TYO: 8086) subsidiary Infraredx said today that it won expanded FDA 510(k) clearance for its Makoto intravascular imaging system, now cleared to identify patients and coronary plaques at an increased risk of major adverse cardiac events.
The approval came based on results from the Lipid-Rich Plaque study in which researchers explored the ability of intravascular ultrasound and near-infrared spectroscopy technology to identify patients and coronary plaques at an increased risk for MACE, the Burlington, Mass.-based company 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,” Infraredx prez & CEO Nozomu Fujita said in a prepared statement.
Data in the study came from 1,563 patients from 44 sites across the U.S. and Europe, and used IVUS+NIRS technology to assess patient and plaque lipid core burden index (LCBI) in both stable and unstable patients requiring and angiogram procedure for new or ongoing cardiac symptoms, Infraredx said.
Results from the trial indicated that patients with a maxLCBI4mm, the term for the max value of any 4mm section, of 400 were at 87% higher risk of non-index culprit lesion related MACE than a patient with a lesser maxLCBI4mm. Results also indicated that the risk of non-index culprit lesion related MACE in a coronary segment with a maxLCBI4mm greater than 400 was more than four times greater than in a segment with lesser maxLCBI4mm.
“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,” principal investigator Dr. Ron Waksman of the MedStar Heart Institute said in a prepared release.
Last September, Infraredx released results from a study of its intravascular ultrasound and near-infrared spectroscopy technology platforms, touting their ability to identify patients and coronary plaques as vulnerable to future major adverse cardiovascular events, including heart attacks.
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