Boston Scientific has received 510(k) clearance from the US Food and Drug Administration (FDA) for its LithoVue Elite Single-Use Digital Flexible Ureteroscope System.
The LithoVue Elite system is claimed to be the first ureteroscope system that can offer real-time intrarenal pressure monitoring during ureteroscopy procedures.
Urologists usually perform a ureteroscopy to diagnose and treat various issues that affect the urinary tract, such as kidney stones.
Due to the built-in pressure sensor on the LithoVue Elite ureteroscope tip, urologists can make informed clinical decisions related to pressure.
The LithoVue Elite System includes the StoneSmart Connect Console and a single-use digital flexible ureteroscope.
It builds on many of the features included in the original LithoVue System.
The device uses a high-resolution digital chip and advanced imaging software to provide quicker, sharper image quality and improved depth of field compared to the original system.
The LithoVue Elite System has two programmable buttons on the lightweight, single-use ureteroscope handle. These enable direct control of video and image capturing without requiring staff coordination.
The compact StoneSmart Connect Console processing unit works with existing operating room visualisation towers and endoscopic monitors to help reduce clutter as well as the capital footprint.
Boston Scientific Urology senior vice-president and president Meghan Scanlon said: “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, optimise patient care and ultimately improve the treatment of kidney stone disease globally.”