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.
“The microparticles in our Acoustic Enhancer are designed to capture energy from the acoustic impulses of URS-LL, and produce rapid, large-amplitude expansions and contractions, then a final cavitation collapse near the stone which causes erosion and fragmentation of the stone,” Applaud Medical Co-Founder and CEO Thomas Kenny said in the release. “Receiving FDA breakthrough device designation for our Acoustic Enhancer will help accelerate the process for obtaining regulatory authorization in the U.S. while also providing support for future incremental reimbursement initiatives for our technology.”