Soundbite Medical announced that it received FDA 510(k) approval for its SoundBite crossing system-peripheral.
Montreal-based Soundbite Medical’s SoundBite crossing system-peripheral (SCS-P) with the 0.014″ active wire (14P) is a recanalization tool designed to help physicians with the 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 artery disease (PAD), according to a news release.
The SoundBite crossing system – peripheral (14P) includes the reusable SoundBite console, a single-use sterile SoundBite active wire 14P and their respective accessories.
SCS-P uses Soundbite’s proprietary method that delivers shockwaves via guidewire platforms to selectively “micro-jackhammer” through calcified lesions.
“This approval is an important step in …