New kidney stone treatment powered by biomedical engineering research receives FDA approval

Note to readers: The Break Wave and Stone Clear devices are not yet available to the public for clinical use. Patients seeking additional information can learn more at the SonoMotion website. 

For the one in 10 people who suffer from kidney stones, a noninvasive treatment called shock-wave lithotripsy can provide much-needed relief.

Now, a technology developed by Virginia Tech researchers has received Food and Drug Administration (FDA) approval for a new approach to lithotripsy that’s even safer, causes less damage to the kidney, and can be administered without anesthesia and in an office setting.   

Burst wave lithotripsy uses sound to break kidney stones into tiny, passable fragments without damaging surrounding tissue. Adam Maxwell, research associate professor in the Department of Biomedical Engineering, developed this next-generation ultrasound technology along with a multi-institutional team of researchers.

Targeted treatment with less damage

When it was first introduced in the 1980s, lithotripsy was considered revolutionary. However, traditional lithotripsy uses high-intensity shock waves that can injure the kidney, and it’s successful only 60 to 70 percent of the time, often leaving large chunks of stone after the procedure. Early systems were cumbersome and physically demanding for patients. 

“Shock waves are powerful, but they’re blunt,” Maxwell explained. “They don’t just break the stone — they also create collateral damage in the kidney.”

Burst wave lithotripsy uses lower-amplitude, oscillating ultrasound bursts to break apart the stones gradually and methodically into tiny uniform particles that can be passed more easily. 

“The key difference is control,” Maxwell said. “We can tailor the ultrasound frequency to control fragment size, reduce pain, and minimize injury to the kidney.”

Cofounded by Maxwell in 2014, California-based medical technology company SonoMotion has developed two burst wave technology medical devices, Break Wave and Stone Clear, that recently received FDA 510(k) clearance. The Break Wave breaks up the kidney stone, while the Stone Clear helps clear the kidney of residual fragments post-lithotripsy. 

"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, co-founder and chief executive officer of SonoMotion.

A welcome side effect

Early clinical studies suggest the procedure is largely painless and would not require anesthesia, unlike current treatments which involve inserting instruments into the urinary tract while under sedation. 

In addition to reducing discomfort, the smaller devices resemble a standard ultrasound probe and are guided by real-time imaging. That means providers can see and target kidney stones at the time of treatment, resulting in a higher success rate.

“This could move kidney stone treatment out of the operating room,” Maxwell said. “Our vision is a first-line therapy that can be done in a clinic or office setting as soon as a stone is diagnosed.”

Working alongside Maxwell in the preclinical research and development were researchers from the following institutions:

• University of Washington
• University of Oxford
• California Institute of Technology
• Indiana University Purdue University at Indianapolis
• University of Illinios Urbana-Champaign

Shaping the future of kidney stone treatment

As burst wave lithotripsy becomes more readily accessible, a safer, simpler, and more patient-friendly way of treating a painful condition affecting over 500,000 Americans each year is closer than ever. 

“For decades, kidney stone treatment hasn’t fundamentally changed,” Maxwell said. “We finally have a chance to rethink the entire patient experience, and that’s incredibly exciting.”