Novel Crossing System for the Recanalization of Complex Chronic Total Occlusions: Ex vivo Proof of Concept of the SoundBite Crossing System.

Chronic total occlusion (CTO) lesions are frequent in patients with peripheral and coronary artery disease, and associated with a higher risk of adverse events, including mortality, decreased quality of life, and increased health-care costs. Percutaneous intervention of CTO lesions has been associated with a lower procedural success rate, and current dedicated CTO devices may be of limited use for the non-CTO expert, and associated with increased intraprocedural complication rates. The SoundBite Crossing System (SoundBite Medical Solutions, Inc) is a newly developed device using shockwaves (short-duration, high-amplitude pressure pulses) to facilitate penetration of the proximal cap and crossing of the occlusion. The current report describes the first use of the SoundBite Crossing System in the recanalization of human ex vivo occluded arteries below the knee during a simulated procedure performed under fluoroscopy. Microcomputed tomography and histologic evaluation of the occluded and recanalized segment are provided to support therapeutic mechanism.