Applaud Medical announced today that it received FDA breakthrough device designation for its Acoustic Enhancer technology.
San Francisco-based Applaud Medical designed its Acoustic Enhancer technology for use in conjunction with ureteroscopy with laser lithotripsy (URS-LL) for the fragmentation of calcium-based urinary stones (at least 6mm and not more than 20mm in diameter) that are obstructing or deemed to present a significant risk of future obstruction by a urologist or other qualified physician.
The Acoustic Enhancer microparticles generate additional stone-fragmenting shockwaves when used during a laser lithotripsy procedure. Applaud Medical is currently conducting a prospective, multi-center, randomized, double-blinded study for the system.
Calcium-based urinary stones obstructing or presenting risk in these cases can place patients at risk of future sepsis, chronic kidney disease or end-stage renal disease, according to a news release.
“Th…