FDA grants breakthrough device designation to laser lithotripsy enhancer

The FDA has granted a Breakthrough Device Designation to Applaud Medical for its Acoustic Enhancer technology for use in conjunction with ureteroscopy with laser lithotripsy (URS-LL) for the fragmentation of calcium-based kidney stones.1

The Acoustic Enhancer, which is specifically intended for stones that have a diameter of between 6 mm and 20 mm, is a micro bubble composed of a gas core with a lipid shell. According to Applaud, acoustic impulses from URS-LL trigger the Acoustic Enhancer to generate additional stone-fragmenting shockwaves when a patient is receiving laser lithotripsy.

“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,” Thomas Kenny, PhD, co-founder and CEO of Applaud, stated in a news release. “Receiving FDA Breakthrough Device Designation for our Acoustic Enhancer will help accelerate the process for obtaining regulatory authorization in the United States while also providing support for future incremental reimbursement initiatives for our technology.”

Initial efficacy and safety evidence for the Acoustic Enhancer were established in human feasibility trials that included 71 patients. The technology is now being further explored in the phase 3 ​Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH) study (NCT04563039).2

Theprospective, multicenter, randomized, double-blind AEROLITH trial is recruiting patients aged 18 to 75 years who have up to 3 urnary stones located proximally to the iliac vessels on one side. Patients are still eligible if they have bilateral stones, but treatment will only be administered to one side. Patients who have a stent in place may still enter the study.

The study is randomizing patients to standard URS-LL with or without Acoustic Enhancer. The primary outcome measured is efficacy, defined as absence of or having residual fragments measuring ≤ 2 mm, and the secondary outcome measure is safety, defined as the total radiant energy used in the treatment. Other key end points include lasering time during treatment, rate of patients receiving further interventional stone treatment, and rates of adverse events.

The study enrollment goal is 196 patients and the study is being conducted at up to 15 clinical sites in the United States.

“There is an increasing prevalence of urinary stone disease due to the rising incidence of obesity, diabetes mellitus, hypertension and dyslipidemia, with obstructions associated with kidney stones at least 6 mm and not more than 20 mm in diameter, putting patients at risk of sepsis, chronic kidney disease, or end-stage renal disease,” Ojas Shah, MD, George F. Cahill Professor of Urology at Columbia University College of Physicians and Surgeons, and director of the Division of Endourology and Stone Disease at Columbia University Medical Center, stated in the news release. “Applaud’s Acoustic Enhancer offers a new approach to breaking kidney stones into smaller fragments, potentially reducing the risk of these complications and the development of future obstructions.”

References

1. Applaud Medical Receives FDA Breakthrough Device Designation for the Company’s Acoustic Enhancer for Use in Conjunction With Ureteroscopy With Laser Lithotripsy (URS-LL) for the Fragmentation of Calcium-Based Kidney Stones. Published online January 31, 2021. Accessed February 1, 2022. https://bwnews.pr/3GkOLKw.

2. NIH ClinicalTrials.gov. Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH) (AEROLITH). Last updated December 22, 2021. Accessed February 1, 2022. https://clinicaltrials.gov/ct2/show/NCT04563039