FDA grants 510(k) clearance to LithoVue Elite System for ureteroscopy

"This device represents an important and needed advancement in single-use ureteroscopes," said Ben Chew, MD MSc.

The FDA has granted 510(k) clearance to the LithoVue Elite Single-Use Digital Flexible Ureteroscope System, according to a news release from Boston Scientific Corporation.¹ The device is the first of its kind with the ability to monitor intrarenal pressure (IRP) in real-time during ureteroscopy procedures to manage kidney stones.

"Multiple studies have shown the importance of understanding intrarenal pressure during ureteroscopy procedures to mitigate potential complications, but until now, urologists have lacked an easy way to measure pressure in real-time. This device represents an important and needed advancement in single-use ureteroscopes, which could help improve patient care and potentially lead to a clearer understanding of the impact of elevated intrarenal pressure on patient outcomes,” said Ben Chew, MD MSc, in a news release on the FDA clearance. Chew is an associate professor at the University of British Columbia in Vancouver.

The LithoVue Elite System was developed by Boston Scientific with additional feedback from physicians. The device is comprised of a single-use digital flexible ureteroscope, as well as the StoneSmart Connect Console, making it the first tool to be built on Boston Scientific’s StoneSmart Technology platform.

The Elite System offers an enhancement of features seen in the original LithoVue System, such as upgraded image quality, updated control features, and streamlined integration.

The device includes a built-in pressure sensor on the tip of the ureteroscope to help urologists make informed clinical decisions during ureteroscopies, where fluid irrigation intended to provide a clear visual field can lead to elevated IRP. It has been shown that high levels of IRP can lead to adverse events in patients, such as systemic inflammatory response syndrome, renal damage, and sepsis.^2,3 Sepsis is associated with the ineffective reprocessing of reusable scopes for the procedure, and by using a single-use scope, the device is expected to eliminate the risk of infection and therefore improve patient outcomes.

"We're at a critical moment in kidney stone care where patient demand is outpacing the number of urologists needed to address it. We designed the next-generation LithoVue Elite System to bring a greater level of precision and functionality in the way urologists diagnose and treat kidney stones, an increasingly common condition among adults. We are committed to developing clinical solutions, like the LithoVue Elite System, that are intended to make procedures more efficient, empower surgical decisions, optimize patient care and ultimately improve the treatment of kidney stone disease globally,” said Meghan Scanlon in the news release. Scanlon is the senior vice president and president of urology at Boston Scientific.

LithoVue Elite System is expected to receive limited market release in the US in the coming weeks.

References

1. Boston Scientific receives FDA clearance for LithoVue Elite Single-Use Digital Flexible Ureteroscope System. News release. Boston Scientific Corportation. Published online January 3, 2023. Accessed January 3, 2023. https://www.multivu.com/players/English/9029351-boston-scientific-fda-clearance-lithovue-elite-system/

2. Tokas T, Herrmann TRW, Skolarikos A, et al. Pressure matters: intrarenal pressures during normal and pathological conditions, and impact of increased values to renal physiology. World J Urol. 2019;37(1):125-131. doi: 10.1007/s00345-018-2378-4

3. Proietti S, Dragos L, Somani B, et al. In vitro comparison of maximum pressure developed by irrigation systems in a kidney model. J Endourol. 2017;31(5):522-527. doi:10.1089/end.2017.0005