Development and testing of a novel and smart hybrid IVUS-OCT sensor for intravascular imaging

Intravascular ultrasound (IVUS) and Optical Coherence Tomography (OCT) are routinely used in the clinical setting to guide PCI procedures. As yet no FDA approved hybrid IVUS-OCT imaging sensor is available to exploit the high resolution imaging of OCT and deep tissue penetration of IVUS. Until now, difficulty in reducing sensor size and maintaining adequate speeds for imaging were identified as stumbling block that prevented this development. We resolved these problems by developing a hybrid sensor with IVUS (50MHz) and OCT, all integrated to a millimeter within the distal end. This catheter-based system is bench tested in ex-vivo human coronary artery cadaver samples. This new imaging system is capable of collecting OCT/IVUS independently and OCT-IVUS together at the same intravascular site at a rate of 60-70 frames/seconds, better than any commercial IVUS system. Also, we were able to identify calcified, thin-capped fibroatheroma (TCFA) and stent struts similar to the conventional OCT and IVUS system and correlated that with histopathology. In addition, we are stenting a porcine artery to test pre, peri and post stenting procedures related maneuvering and imaging and the results from this study will be shown in the meeting. For the first time, we have developed a high-speed hybrid-imaging catheter that is capable of performing IVUS and OCT imaging alone and combined IVUS-OCT imaging using a single catheter. We are planning human clinical trial at three different centers in US and internationally