FDA Clears Soundbite’s Peripheral Crossing System

April 23, 2021

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.

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