Key Points
- SonoMotion’s Break Wave™ lithotripsy system has received clearance for the treatment of kidney stones.
- The noninvasive, anesthesia-free procedure does not require a stent and can be performed at many sites of care.
SonoMotion has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its Break Wave™ lithotripsy system for the treatment of kidney stones. The device uses low-pressure focused ultrasound to noninvasively fragment stones in the kidney or ureter under real-time ultrasound guidance.
Various mechanisms of lithotripsy have been used to break up painful kidney stones for decades, but the techniques vary in level of invasiveness. Unlike other forms of lithotripsy, the Break Wave device is noninvasive, anesthesia-free, does not require a ureteral stent, and can be performed at many sites of care including the clinic, emergency department, or a hospital. Because anesthesia is not needed, patients can eat and drink the night before and can drive themselves to and from the procedure.
The FDA clearance was based on data from the company’s SOUND Break Wave pivotal trial (NCT05701098), which took place at ten centers in Canada and the US. The SOUND study results will be formally presented at the upcoming American Urological Association (AUA) Annual Meeting in May in Washington, DC.
SonoMotion’s recent clearance builds on previous regulatory success: Its Stone Clear™ device received FDA de novo clearance in late 2024 to facilitate passage of residual stone fragments after lithotripsy. The two devices work together to fragment stones and then help the resulting fragments clear the kidney.
“Receiving FDA clearance is a pivotal milestone for our company and, more importantly, for patients seeking better options for kidney stone treatment,” said Oren Levy, PhD, co-founder and chief executive officer of SonoMotion. “This 510(k) clearance represents a significant step toward commercialization, and we look forward to scaling manufacturing and making our noninvasive, anesthesia-free solutions available to patients and providers across the urology community.”
The company plans to begin commercial treatments later this year.