The Food and Drug Administration (FDA) has granted de novo clearance to Stone Clear, an innovative ultrasound device developed by SonoMotion, designed to aid in the clearance of kidney stone fragments following lithotripsy procedures. This clearance marks a significant advancement in the non-invasive management of residual kidney stones, offering a new option for patients at risk of complications.
How Stone Clear Works
Stone Clear utilizes ultrasound propulsion to reposition residual kidney stone fragments after lithotripsy. This process facilitates easier natural passage and clearance of the fragments. According to SonoMotion, the procedure is completed in about 15 minutes and does not require anesthesia, making it a convenient option for patients.
Clinical Trial Results
A recent prospective multicenter trial evaluated the efficacy of Stone Clear. The results indicated that ultrasound propulsion with the device led to a 70% reduction in the risk of relapse compared to a control group undergoing observation. This data suggests a substantial benefit in reducing the burden of residual stone fragments.
Expert Commentary
Dr. James E. Lingeman, a clinical professor of urology at the Indiana University School of Medicine, highlighted the importance of this new technology. "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," he stated. "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."
Implications for Patient Care
The Stone Clear device addresses a critical unmet need in post-lithotripsy care. By offering a non-invasive method to clear residual kidney stone fragments, it has the potential to reduce complications and the need for further interventions, improving patient outcomes and quality of life.
