Recanalization of CTOs with SoundBite™ Active Wire

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Medical Device Technology

Background:

• Infrainguinal chronic total occlusions (CTOs) are common in patients with severe limb ischemia.
• Recanalization of CTOs is challenging and associated with poor prognosis.
• The SoundBite™ Crossing System is a novel device designed to facilitate CTO crossing using acoustic shock waves.

Purpose of the Study:

• To evaluate the safety and efficacy of the SoundBite™ Crossing System for infrainguinal CTO recanalization.
• To determine the 30-day device success rate of the SoundBite™ Active Wire.

Main Methods:

• A prospective, single-arm feasibility study enrolled 37 patients with de novo infrainguinal CTOs across 3 centers.
• The primary endpoint was 30-day device success, a composite of technical success and freedom from device-related major adverse events.
• Technical success involved penetration and progression within the CTO with the SoundBite™ Active Wire and complete recanalization.

Main Results:

• The study included 37 patients and 41 CTO lesions, with a mean length of 97.9 mm and significant calcification in 58.5%.
• CTOs were successfully crossed in 91.9% of patients.
• A 30-day device success rate of 91.9% was achieved with no device-related adverse events. Significant improvements in ankle-brachial index and Rutherford class were observed.

Conclusions:

• The SoundBite™ Active Wire Crossing System demonstrated a favorable safety and efficacy profile in this feasibility study.
• The device shows promise for treating infrainguinal CTOs.
• Further investigation may be warranted to confirm these findings in larger trials.