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Ultrasound Device Garners FDA De Novo Nod for Kidney Stone Clearance
Emerging research demonstrated that the Stone Clear device, which facilitates post-lithotripsy clearance of kidney stone fragments, led to a 70 percent lower risk of relapse in comparison to observation in a control group.
The Food and Drug Administration (FDA) has issued a de novo clearance for Stone Clear, an ultrasound device that enables post-lithotripsy passage of kidney stone fragments.1
Through ultrasound propulsion, the Stone Clear modality reportedly repositions residual kidney stone fragments from lithotripsy procedures, allowing easier natural passage and clearance, according to SonoMotion, the manufacturer of Stone Clear.1 The company said the Stone Clear procedure does not require anesthesia and can be completed in 15 minutes.
A recent prospective multicenter trial found that ultrasound propulsion with the Stone Clear device facilitated a 70 percent lower risk of relapse in comparison to observation in a control group. (Image courtesy of SonoMotion.)
A recent prospective multicenter trial found that ultrasound propulsion with the Stone Clear device facilitated a 70 percent lower risk of relapse in comparison to observation in a control group.2
"Patients with post-lithotripsy residual fragments are more likely to have complications, emergency department visits, or repeat procedures, yet they have no reliable non-invasive option aside from passive observation," said James E. Lingeman, M.D., a clinical professor of urology at the Indiana University School of Medicine. "The Stone Clear device provides patients with a non-invasive option to reduce their residual fragment stone burden in the clinic environment while being fully awake."
References
1. SonoMotion. SonoMotion announces FDA de novo clearance for its Stone Clear device. PR Newswire. Available at: https://www.prnewswire.com/news-releases/sonomotion-announces-fda-de-novo-clearance-for-its-stone-clear-device-302303764.html . Published November 13. 2024. Accessed November 13, 2024.
2. Sorenson MD, Dunmire B, Thiel J, et al. Randomized controlled trial of ultrasonic propulsion-facilitated clearance of residual kidney stone fragments vs observation. J Urol. 2024;212(6):811-820.
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