Infraredx, a Nipro Company, and B. Braun Interventional Systems Inc., an Affiliate of B. Braun Medical Inc., Announce Strategic U.S. Collaboration to Execute the IDE Clinical Trial for the SeQuent® Please ReX™ Drug Coated PTCA Balloon Catheter.
The Makoto™ Intravascular Imaging System, with accompanying Dualpro™ IVUS+NIRS Catheter, is the only imaging system on the market today that utilizes not just intravascular ultrasound (IVUS) but also Near-Infrared Spectroscopy (NIRS) to help clinicians visualize vessel structure and gain valuable insights into plaque composition. Our revolutionary technology is the only FDA-cleared imaging technology indicated for the detection of Lipid Core Plaque (LCP).
To identify lipids such as cholesterol
Organic molecules have unique spectroscopic signatures that can be used to detect their presence in a mixture of unknown composition. NIRS allows us to distinguish molecules, such as collagen and cholesterol, within the vessel wall and thus identify the presence of LCP.
Through blood, tissue and interstitial spaces
The microscopic mirrors at the tip of the Dualpro™ catheter are designed to deliver near-infrared light to the vessel wall and collect the diffusely reflected light. The light propagates through blood and tissue by scattering and absorption, even in the presence of calcium or stents, to interrogate the plaque for its chemical fingerprint.
With the aid of advanced algorithms
Advanced algorithms analyze the returned light and calculate the probability of the presence of a lipid core plaque. Our algorithms have been validated in a large prospective histology study providing you with information you can trust.
The Makoto™ Intravascular Imaging System was designed with the primary goal of helping you make quick and informed decisions at the bedside. The easy-to-interpret chemogram provides insight into the complex plaques that complicate your interventional strategy, treatment procedures, and patient’s recovery.
Approximately 1,300 NIRS spectra per millimeter are acquired as the catheter scans the vessel.¹
The acquired NIRS signals are analyzed and each spectrum is assigned a probability score, from 0 to 1, based on the likelihood of the presence of LCP.
All probability scores, low to high, are mapped on a continuous color scale from red to yellow. Scores above 0.6 appear orange to yellow in the chemogram and contribute to the Lipid Core Burden Index (LCBI).
The chemogram is automatically generated within seconds, creating a map of the LCP location within the vessel wall. This color-coded map can be interpreted quickly, permitting informed treatment decisions.
Data you can trust:
Nearly 2,500 artery cross-sections were histologically and spectrally analyzed to validate lipid core plaque detection by NIRS. The red and yellow colors on the chemogram help differentiate normal or fibrotic plaque that is presumed to be stable (left) from those that contain lipid core plaques (right).²
¹ In a 150mm scan at 05.mm/s
² Detection of lipid core coronary plaques in autopsy specimens with a novel catheter-based near-infrared spectroscopy system, Gardner er al, JACC Cardiovasc Imaging, 2008
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