Applaud Medical’s Kidney Stone Fragmenter Designated a Breakthrough Device
The FDA has designated Applaud Medical’s Acoustic Enhancer for breaking up kidney stones a breakthrough device.
Designed for use in conjunction with laser treatment, the device generates additional stone-fragmenting shockwaves when used during the laser procedure.
The Acoustic Enhancer is intended to treat kidney stones between 6 and 20 millimeters in diameter that are obstructing or deemed to present a significant risk of future obstruction. Such large kidney stones can place patients at risk of sepsis, chronic kidney disease, or end-stage renal disease.