Soundbite Medical Solutions has announced US Food and Drug Administration (FDA) 510(k) approval for the SoundBite crossing system—Peripheral (SCS-P) with the 0.014” active wire (14P).
The SoundBite crossing System—Peripheral (14P) is a recanalisation tool, designed to help physician’s placement of conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions (CTOs) in patients suffering from heavily calcified above-the-knee (ATK) and below-the-knee (BTK) peripheral arterial disease (PAD).
The SoundBite crossing system—Peripheral (14P) consists of the reusable SoundBite console, a single-use sterile SoundBite active wire 14P, and their respective accessories. SCS-P leverages Soundbite’s proprietary method to produce and safely deliver shock waves via guidewire platforms to selectively “micro- jackhammer” through calcified lesions. SCS-P is now approved in major markets with CE mark, FDA 510(k), and Health Canada approvals in both 0.018” and 0.014’’ platforms.