Soundbite Medical Solutions has announced Health Canada approval for the SoundBite Crossing System – Peripheral (SCS-P) with the 0.014” Active Wire (14P).
The SCS-P (14P) is intended for the treatment of patients suffering from peripheral arterial disease (PAD) with heavily calcified above-the-knee (ATK) and below-the-knee (BTK) chronic total occlusions (CTOs).
“Expanding our technology and product portfolio in Canada is an important milestone for our company in the journey to commercialise the SoundBite system. This is welcome news on the back of our recent positive experience with the system in the EU. We are looking forward to making a positive impact on patients by providing a novel and safe solution around the world,” said Lori Chmura, president and CEO of SoundBite Medical.
The SCS-P 14P system comprises the SoundBite Console and the 0.014” SoundBite Active Wire. SCS-P leverages Soundbite’s proprietary method to produce and safely deliver shock waves via guidewire platforms to selectively ‘micro- jackhammer’ through calcified lesions. SBCS-P has CE mark and Health Canada approval in both 0.018” and 0.014’ platforms; the 0.018” platform has also US Food and Drug Administration (FDA) (510k) approval.