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April 22, 2021
FDA Clears SoundBite Crossing System-Peripheral (14P)
April 22, 2021—SoundBite Medical Solutions Inc. announced FDA 510(k) clearance for the SoundBite crossing system–peripheral (SCS-P) with the 0.014-inch Active Wire (14P). The recanalization tool is designed to help placement of conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions in patients with heavily calcified above-the-knee and below-the-knee peripheral artery disease.
According to the company, SCS-P produces and safely delivers shock waves via guidewire platforms to selectively “micro-jackhammer” through calcified lesions.
The SCS-P (14P) is composed of the reusable SoundBite console, a single-use sterile SoundBite Active Wire 14P, and their respective accessories. The SCS-P device now has CE Mark approval, FDA 510(k) clearance, and Health Canada approval in 0.018-inch and 0.014-inch platforms, advised the company.
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