SonoMotion's Stone Clear Receives FDA De Novo Clearance for Post-Lithotripsy Kidney Stone Fragment Clearance
核心洞察
SonoMotion (搜索)'s Stone Clear (搜索) device has received FDA de novo clearance for non-invasive removal of kidney stone fragments post-lithotripsy (搜索).
The device utilizes external ultrasound pulses to facilitate the movement and passage of residual kidney stone fragments.
Clinical trials showed a 70% reduction in relapse risk with Stone Clear (搜索) compared to standard observation for post-lithotripsy (搜索) patients.
SonoMotion (搜索), a medical device company focused on non-invasive kidney stone solutions, has announced that the FDA has granted de novo clearance for its Stone Clear (搜索) device. This clearance marks a significant advancement in the treatment of residual kidney stone fragments following lithotripsy (搜索).
The Stone Clear (搜索) device is the first of its kind to use external ultrasound pulses to facilitate the movement and passage of kidney stone fragments without the need for surgery. This non-invasive approach aims to reduce complications and the need for repeat procedures in patients who have undergone lithotripsy (搜索), a common procedure to break up kidney stones (搜索).
Clinical Trial Results
Clinical trial data, published in the December 2024 issue of the Journal of Urology, demonstrated that ultrasound propulsion with the Stone Clear (搜索) device reduced the risk of relapse by 70% compared to standard observation in patients with post-lithotripsy (搜索) residual fragments. The study included a randomized controlled trial with up to five-year follow-up.
"Patients with post-lithotripsy (搜索) 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, MD, Clinical Professor of Urology, Indiana University School of Medicine. "The Stone Clear (搜索) device provides patients with a non-invasive option to reduce their residual fragment stone burden in the clinic environment while being fully awake."
Device Details and Future Applications
The Stone Clear (搜索) device is designed to be used in various healthcare settings, including doctor's offices and emergency departments, without requiring anesthesia. This offers a significant advantage over traditional methods that may require more invasive procedures and longer recovery times.
SonoMotion (搜索) is also developing Break Wave (搜索), a second solution that will use focused ultrasound to non-invasively fragment kidney stones (搜索) in the upper urinary tract without anesthesia. Break Wave is currently undergoing clinical trials in the United States and Canada.
Market and Economic Impact
Kidney stones (搜索) affect approximately one in ten people in the United States, resulting in an estimated $10 billion in annual healthcare costs. The Stone Clear (搜索) device has the potential to reduce these costs by providing a less invasive and more effective treatment option for post-lithotripsy (搜索) patients.
"SonoMotion (搜索)'s goal is to fundamentally change how kidney stones (搜索) are treated, and securing FDA clearance for Stone Clear (搜索) is a major milestone towards this goal," commented Oren Levy, PhD, Co-Founder and Chief Executive Officer, SonoMotion. "SonoMotion's technologies have the potential to be a first-line treatment for kidney stones, offering a solution for patients who want to avoid anesthesia, minimize wait times for surgery without the need for urinary stenting – a procedure often more painful than the kidney stone itself."