SoundBite peripheral crossing system gains FDA approval

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Soundbite Medical Solutions has announced 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 recanalization 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.

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