Soundbite Medical announced that it received FDA 510(k) clearance 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). The device can help people 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 furthering our mission of making a positive impact on the lives of patients with critical limb ischemia (CLI) and challenging calcified BTK disease,” Soundbite Medical president & CEO Lori Chmura said in the release. “We believe that this approval is very relevant as it represents the latest testament to our comprehensive and long-term commitment to revolutionizing the treatment of CTOs and PAD with our family of safe and effective active solutions.”