The Food and Drug Administration has approved a new approach to kidney stone treatment that could transform care for the millions of Americans who experience this painful condition each year. The technology, called burst wave lithotripsy, uses targeted ultrasound waves to break stones into tiny passable fragments without the need for anesthesia or an operating room.
For the one in 10 people who develop kidney stones, traditional treatment has long involved shock wave lithotripsy, a method introduced in the 1980s that uses high intensity shock waves. While revolutionary at the time, that approach succeeds only 60 to 70 percent of the time and often leaves large stone fragments behind. It can also injure kidney tissue. The new method, burst wave lithotripsy, uses lower amplitude oscillating ultrasound bursts that break stones gradually into uniform particles small enough to pass naturally. Early clinical studies suggest the procedure is largely painless and would not require sedation.
Two devices based on this technology have received FDA clearance. The Break Wave device breaks up the kidney stone, while the Stone Clear device helps clear residual fragments after the procedure. Unlike current treatments that involve inserting instruments into the urinary tract under sedation, these devices resemble a standard ultrasound probe and are guided by real time imaging. This allows providers to see and target stones during treatment, potentially leading to higher success rates. The smaller size of the equipment also means the procedure could be performed in a clinic or office setting rather than a hospital operating room.
Over 500,000 Americans seek treatment for kidney stones each year. The approval marks a shift toward a safer, simpler and more patient friendly approach to a condition that has seen little fundamental change in treatment for decades. Researchers say the next step is making burst wave lithotripsy widely accessible as a first line therapy, offering relief as soon as a stone is diagnosed.