WASHINGTON -- An in-office device that uses low-pressure ultrasound waves to breaking up kidney stones was safe and effective, according to data from the SOUND trial.
Treatment with the Break Wave lithotripsy device reduced stones to passable fragments of ≤4 mm in seven out of 10 patients and with minor complication, reported Benjamin Chew, MD, of the University of British Columbia in Vancouver.
"Break Wave offers a safe and efficacious non-invasive and anesthesia-free treatment option at any healthcare setting." Chew said in a presentation at the AUA annual meeting. The device received FDA clearance in January, according to the developer, while in May, the company got the FDA green light for the next-generation Break Wave device.
SOUND had 64 adults with an upper urinary tract stone that had to be >4 mm and ≤10 mm on CT; indicated for extracorporeal shock wave lithotripsy (ESWL) per American Urological Association (AUA) criteria; and be individually separable from other stones.
Chew reported that that 94% of the procedures were completed in clinic settings, which speaks to the device's portability and workflow flexibility. In addition, all patients tolerated treatment without anesthesia or sedation, eliminating pre-op clearance, post-anesthesia care unit recovery, and anesthesiology support.
