FDA Clears Expanded Label Claim for Infraredx's Makoto IVUS System
April 22, 2019—Infraredx, a Nipro Company, announced that it has received FDA 510(k) clearance to expand the indications for use for its Makoto intravascular ultrasound (IVUS) imaging system. The label claim expands usage guidelines to include identification of patients and plaques at increased risk of major adverse cardiac events (MACEs).
The Makoto IVUS system uses near-infrared spectroscopy (NIRS) to detect lipid core plaque (LCP) and automatically displays the results via a simple, color-coded chemogram. The system automatically generates lipid core burden index (LCBI) calculations and the chemogram, which displays the presence of LCP in yellow and absence in red. The Makoto system was launched in Japan in 2018. The company will continue expansion into the United States and European Union markets.
According to Infraredx, the FDA clearance was supported by the results of the Lipid-Rich Plaque (LRP) study, which demonstrated the ability of the system’s IVUS plus NIRS technology to identify patients and coronary plaques at an increased risk for MACEs. The LRP study enrolled 1,563 patients from 44 sites in the United States and Europe to evaluate its IVUS plus NIRS technology to assess patient and LCBI in stable and unstable patients requiring an angiogram procedure for new or ongoing cardiac symptoms.
Principal investigator Ron Waksman, MD, presented the LRP study at TCT 2018, the 30th annual Transcatheter Cardiovascular Therapeutics scientific symposium, which was held September 21–25 in San Diego, California.
The data Dr. Waksman presented at TCT 2018 showed that patients with a maxLCBI4mm (maximum LCBI value of any 4-mm section of a scanned or selected region) > 400 were at 87% higher risk of nonindex culprit lesion-related MACEs than a patient with a lower maxLCBI4mm value. In addition, the study found that the risk of nonindex culprit lesion-related MACEs in a coronary segment with a maxLCBI4mm > 400 is more than fourfold higher than in a segment with a lower maxLCBI4mm value.
Dr. Waksman commented in the Infraredx announcement, “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 nonculprit 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.”
Antonio Colombo, MD, added, “The Makoto imaging system significantly advances the field of intracoronary imaging. We are already successfully employing the system at our hospital and collecting key insights from the chemogram information it provides. The information we receive from the system helps to make more personalized treatment decisions for my patients.”
Also in the company's press release, Gregg W. Stone, MD, Principal Investigator of the ongoing PROSPECT II study, stated, “The new FDA indication for NIRS for identification of patients and plaques at increased risk of [MACEs] is a landmark achievement. The emerging data that this imaging technology can identify dangerous plaques that may suddenly progress should enable development of new therapeutic approaches to improve the prognosis of these high-risk patients.”