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Novel Crossing System for Chronic Total Occlusion Recanalization: First-in-Man Experience With the SoundBite Crossing
Andrew Benko, Simon Bérubé, Christopher E Buller
1Gagnon Cardiovascular Institute, Morristown Medical Center, 100 Madison Avenue, Morristown, NJ 07960 USA. pgenereux@crf.org.
Insights
Chronic total occlusions (CTO) pose risks in artery disease. A new shockwave device shows promise for crossing these difficult lesions in initial human use.
Area of Science:
- Vascular surgery
- Interventional cardiology
Background:
- Chronic total occlusions (CTO) are common in peripheral and coronary artery disease.
- CTO interventions have lower success rates and higher complication risks, especially for non-experts.
- Existing devices may have limited efficacy for complex CTO lesions.
Observation:
- The SoundBite Crossing System utilizes guidewire-mounted shockwaves to penetrate CTOs.
- This report details the first human application of the SoundBite system.
- The system was used to recanalize two occluded lower-limb arteries.
Findings:
- The SoundBite Crossing System facilitated guidewire penetration through the proximal cap.
- Successful crossing of the CTO lesions was achieved in the reported cases.
- The device's shockwave technology appears effective for CTO lesion crossing.
Implications:
- This novel device may offer a new solution for challenging CTO interventions.
- It could potentially improve procedural success rates and reduce complications.
- Further studies are warranted to evaluate its broader clinical utility in CTO treatment.
Abstract:
Chronic total occlusion (CTO) lesions are frequent in patients with peripheral and coronary artery disease, and are 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 non-CTO experts, 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) delivered to the tip of guidewire to facilitate penetration of the proximal cap and crossing of the occlusion. The current report describes the first-in-man use of the SoundBite Crossing System in the recanalization of two occluded lower-limb arteries.
