Updated: Medtech Infraredx Anticipates Trial Data Will Support ‘Holy Grail’ of Cardiovascular Imaging Tool


A new cardiovascular imaging tool could prevent the possibility of people experiencing a second or third heart attack.

Jason Bottiglieri, president and chief executive officer of Burlington, Mass.-based Infraredx, said cardiovascular disease is the number one killer of men and women globally. Many people who survive the first heart attack have second and third events, Bottiglieri told BioSpace in an exclusive interview.

InfraredX has developed the Makoto Intravascular Imaging System and Dualpro catheter as a tool to help in the prevention of subsequent heart attacks. The system uses intravascular ultrasound and near-infrared spectroscopy (IVUS+NIRS) to identify vessel structure and composition of lipid plaque. The pools of lipid plaque in the arteries can lead to thrombotic events, said Bottiglieri, who assumed the role of CEO at InfraredX in 2015.

Using the IVUS+NIRS technology has the potential to change the field of interventional cardiology, Bottiglieri said. The combination of two modalities in one catheter is capable of providing cardiologists double the information of other imaging catheters, he said. With this, physicians can select which therapies are best for patients in order to prevent future heart attacks, Bottiglieri said.

The InfraredX device is used similarly to the way physicians used a balloon and stent, Bottiglieri said. Images gathered from the Makoto Intravascular Imaging System and Dualpro catheter show a localized segment of a coronary artery. With the combination of IVUS+NIRS, physicians can determine the chemical composition of lipid pools and use that to gauge treatment options.

Bottiglieri said it’s critical that physicians have the right tool to prevent heart attacks in patients and he believes InfraredX is on the cusp of having a device that will be able to do just that.

“We think this will be meaningful for the field. This could be the Holy Grail for cardiology,” Bottiglieri said.

Whether or not InfraredX has found the key tool for cardiologists remains to be seen. The company though is expecting data from a clinical trial that could support Bottiglieri’s bold prediction. Results from the Lipid-Rich Plaque (LRP) Study could pave the way for a U.S. market launch of the Makoto Imaging System and Dualpro catheter. Data from the trial will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2018 Scientific Symposium on Sept. 24. The LRP Study is designed to identify a correlation between lipid core plaque (LCP) and the occurrence of major adverse cardiovascular events (MACE) within two years.

Bottiglieri said this will be the definitive trial for the system.

“We never had the data, it was all anecdotal but now will have the definitive trial,” he said.

Bottiglieri said they’ve “long believed” that because of the anecdotal evidence will bear out in the data study. If the data bears out as he expects, Bottiglieri said the company is already eyeing potential clinical studies that pair the system with drugs or prophylactic stent.

Infraredx released the results of that study on Sept. 24. The results show that the company’s technology has the capabilities to successfully identify patients and coronary plaques as vulnerable to future major adverse cardiovascular events (MACE), such as heart attacks. The study met its co-primary endpoints, which included the association of patient-level of max-lipid core burden index (LCBI) with a vulnerable patient, as well as the association of plaque-level maxLCBI with vulnerable plaques, lesions within a pre-imaged segment likely to cause a future MACE in that specific segment.

The company has already commercially launched the system in Japan, where imaging plays a significant part of the Japanese angioplasty procedure, Bottiglieri said.

Bottiglieri said that getting patients to comply with medical recommendations isn’t as easy as it should be. He noted that a physician can tell a patient who is diabetic to quit smoking because of the hazards to their health. For many patients though, the advice falls on deaf ears. Now though, Bottiglieri said the Makoto Intravascular Imaging System and Dualpro catheter can provide a snapshot of the coronary artery that could show those patients there are lipid pools and how that can lead to a heart attack.

“This could help them be more compliant,” he said.

With the data readout close, InfraredX is planning its next steps. The company signed a long-term lease for a space that is about 50 percent larger than its current digs. Bottiglieri said this will allow them to conduct all research and development under one roof in Burlington, Mass.

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