FDA Clears Soundbite’s Peripheral Crossing System
Soundbite has obtained 510(k) clearance for its SoundBite Crossing System, a recanalization tool that helps restore blood flow to arteries using the company’s novel 0.014-inch active wire.
Physicians use the device to place conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions in patients with heavily calcified above-the-knee and below-the-knee peripheral artery disease.
The crossing system features a reusable console and a single-use sterile active wire. It produces and delivers safe shockwaves via its guidewire platforms to “micro-jackhammer” its way through calcified lesions, the company said.