SoundBite Medical Solutions’ PAD Crossing System Gets Canadian Approval

Health Canada has approved the 0.014-inch active-wire version of SoundBite Medical Solutions’ SoundBite Crossing System Peripheral for treating peripheral artery disease (PAD).

The platform is intended for treating patients suffering from PAD with heavily calcified above-the-knee and below-the-knee chronic total occlusions. It includes a console device and the 0.014-inch active wire.

The device safely delivers shock waves via guidewire platforms to break through calcified lesions. The company’s 0.018-inch platform has received FDA 510(k) clearance, Health Canada approval and the CE mark, while its 0.014-inch platform has also received the CE mark.