SoundBite Introduces 0.014-Inch Active Wire Crossing System to Treat Below-The-Knee CTOs

January 26, 2021—SoundBite Medical Solutions Inc. (SBMS) announced the first use of its Active Wire 0.014-inch platform in the successful treatment of patients who have critical limb ischemia with heavily calcified below-the-knee (BTK) chronic total occlusions (CTO).

The procedures were performed by Professor Marianne Brodmann, MD, Head of the Clinical Division of Angiology, Department of Internal Medicine, and Peter Rief, MD, at the Medical University of Graz in Graz, Austria.

According to the company, the SoundBite crossing system–peripheral (SBCS-P) is a wire-based active device (Active Wires) for crossing CTOs. SBCS-P leverages the company’s method to produce and safely deliver shock waves via guidewire platforms to selectively “microjackhammer” through calcified lesions. The SMPS-P has received CE Mark approval and is available in 0.018- and 0.014-inch platforms. The 0.018-inch platform has received FDA 510(k) clearance and Health Canada approvals, advised the company.

“Vascular calcium poses a major challenge for the endovascular treatment of lesions,” commented Prof. Brodmann in the SBMS press release. “Our early experience with the 0.014-inch platform of the SoundBite crossing system in five patients with calcific BTK CTOs shows impressive crossing efficacy and handling with no procedural complications, including perforations, early recoil, or distal embolization in this difficult-to-treat patient population. The SoundBite technology holds promise to significantly transform the treatment of calcified vascular occlusions in patients with peripheral artery disease.”