Boston Scientific (NYSE:BSX) announced today that it received FDA 510(k) clearance for its LithoVue Elite single-use ureteroscope system.
Marlborough, Massachusetts-based Boston Scientific plans a limited U.S. launch for the digital, flexible ureteroscope system in the coming weeks.
The company said in a news release that it’s the first ureteroscope system that can monitor intrarenal pressure in real-time. Its built-in pressure sensor allows urologists to make informed, pressure-related clinical decisions.
“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,” said Dr. Ben Chew, associate professor, University of British Columbia. “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.”
About the Boston Scientific LithoVue Elite system
The single-use ureteroscope and the StoneSmart Connect console comprise the LithoVue Elite system. It builds on features of the original LithoVue system, launched in 2016. However, it also includes next-generation innovations in addition to its intrarenal pressure monitoring.
Enhancements include upgraded image quality, updated control features and streamlined integration, Boston Scientific said.
The system features a high-resolution digital chip and advanced imaging software. These provide faster, sharper image quality and improved depth of field compared to the original LithoVue system.
Boston Scientific added two programmable buttons on the lightweight, single-use ureteroscope handle. These enable direct control of video and image capture without the need to coordinate with staff.
Finally, the StoneSmart Connect console, a compact processing unit, works within existing OR visualization towers and endoscopic monitors. The company said this reduces clutter and capital footprint.
“We’re at a critical moment in kidney stone care where patient demand is outpacing the number of urologists needed to address it,” said Meghan Scanlon, SVP and president, Urology, Boston Scientific. “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.”