The FDA has approved marketing of the LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System from Boston Scientific, according to a press release from the manufacturer. It is the first ureteroscope that can monitor intrarenal pressure in real-time during ureteroscopy procedures.
Elevated intrarenal pressure can occur during fluid irrigation to maintain a clear visual field in the upper urinary tract. High pressure can lead to complications such as fluid absorption, pyelovenous backflow, kidney damage, infection, systemic inflammatory response syndrome, and sepsis.
A pressure sensor is built into the tip of the ureteroscope and provides real-time measurements, allowing the urologist 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,” Ben Chew, MD, MSc, of the University of British Columbia, stated in the release. “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.”
Boston Scientific receives FDA clearance for LithoVue™ elite single-use digital flexible ureteroscope system. News release. Boston Scientific; February 3, 2022.