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. The post Soundbite Medical Solutions announces FDA approval for SoundBite peripheral crossing system appeared first on Vascular News.