InfraRedx touts Makoto, Dualpro platform study results
Infraredx this week 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.
Results were presented at the Transcatheter Cardiovascular Therapeutics conference this week, the company said.
“The role lipid rich plaques play in cardiovascular-related deaths has been studied for decades. Today’s findings validate that NIRS use in vivo can identify both vulnerable patients and vulnerable coronary plaque. We are grateful to the physicians, patients and employees who have helped to achieve this transformational milestone. We are proud our technology has contributed to these important findings, and we will continue our fight against cardiovascular disease, working to empower physicians to discover new treatments and preventive medicines,” prez & CEO Jason Bottiglieri said in a prepared statement.
Investigators in the prospective, multicenter, 1,563-patient Lipid-Rich Plaque study explored the ability of the company’s Makoto intravascular imaging system and its Dualpro IVUS+NIRS catheter in detecting lipid core plaque, which the company said is the underlying cause of most coronary deaths.
The Makoto and Dualpro system are designed to detect LCP and automatically display the results in a color-coded map called a chemogram, the Burlington, Mass.-based company said.
Study researchers used the combined technology to assess patient and plaque lipid core burden index, as well as a metric derived from the chemogram as the maximum lipid burden in any 4mm segment, dubbed maxLCBI4mm, the company said.
Results indicated that the study met its co-primary endpoints, which are the association of patient-level maxLCBI4mm with vulnerable patients likely to experience non-culprit MACE, as well as the association of plaque-level maxLCBI4mm with vulnerable plaques and lesions within a pre-imaged segment likely to cause future MACE in that specific segment, Infraredx said.
Data indicated that the occurrence of non-culprit MACE events within 24 months was 18% higher with each 100 unit increase in maxLCBI4mm, showing that a patient with a maxLCBI4mm greater than 400 was at an 87% higher risk than a patient with lower maxLCBI4mm, the company said.
“These results have the potential to transform not only the field of intravascular imaging, but how we practice interventional cardiology. The ability to identify lipid core plaque and risk stratify patients by the probability of MACE could open up new and transformational opportunities for cardiovascular research and treatment strategies,” LRP study principal investigator Dr. Ron Waksman of Washington D.C.’s MedStar Heart and Vascular Institute said in a press release.