ABSTRACT

Crossing chronic total occlusions (CTOs) continues to present a challenge for coronary and peripheral interventionalists. The CROSSER Catheter offers a different approach that allows the blunt catheter tip to present itself to the proximal cap, and high-frequency vibrational energy to be used to proceed through the blockage. This catheter system consists of reusable electronics and the single-use CROSSER Catheter. In addition to the direct mechanical ablation, high-frequency vibration can create vapor-filled microbubbles in the fluid at the tip of the CROSSER Catheter. The monorail CROSSER Catheter is advanced to the totally occluded vessel over a conventional coronary guidewire. In the pivotal phase, using the improved version of the CROSSER Catheter, the primary endpoint of device efficacy was 76%, and the secondary endpoint of clinical success was also 76%. The CROSSER Catheter continued to advance with moderate resistance, and periodic contrast injections were taken to ascertain that the device was going in the appropriate direction.