The Meals and Drug Administration (FDA) has issued a de novo clearance for Stone Clear, an ultrasound gadget that permits post-lithotripsy passage of kidney stone fragments.1
By way of ultrasound propulsion, the Stone Clear modality reportedly repositions residual kidney stone fragments from lithotripsy procedures, permitting simpler pure passage and clearance, in keeping with SonoMotion, the producer of Stone Clear.1 The corporate stated the Stone Clear process doesn’t require anesthesia and could be accomplished in quarter-hour.
A latest potential multicenter trial discovered that ultrasound propulsion with the Stone Clear gadget facilitated a 70 p.c decrease threat of relapse compared to statement in a management group. (Picture courtesy of SonoMotion.)
A latest potential multicenter trial discovered that ultrasound propulsion with the Stone Clear gadget facilitated a 70 p.c decrease threat of relapse compared to statement in a management group.2
“Sufferers with post-lithotripsy residual fragments usually tend to have issues, emergency division visits, or repeat procedures, but they haven’t any dependable non-invasive choice except for passive statement,” stated James E. Lingeman, M.D., a scientific professor of urology on the Indiana College College of Drugs. “The Stone Clear gadget offers sufferers with a non-invasive choice to cut back their residual fragment stone burden within the clinic atmosphere whereas being totally awake.”
References
1. SonoMotion. SonoMotion proclaims FDA de novo clearance for its Stone Clear gadget. PR Newswire. Obtainable at: https://www.prnewswire.com/news-releases/sonomotion-announces-fda-de-novo-clearance-for-its-stone-clear-device-302303764.html . Revealed November 13. 2024. Accessed November 13, 2024.
2. Sorenson MD, Dunmire B, Thiel J, et al. Randomized managed trial of ultrasonic propulsion-facilitated clearance of residual kidney stone fragments vs statement. J Urol. 2024;212(6):811-820.
