Boston Scientific has received the US Food and Drug Administration (FDA) 510(k) approval for its single-use digital flexible ureteroscope system, LithoVue Elite.
LithoVue Elite System is the latest device in the company’s portfolio of single-use imaging devices and is created based on its next-generation StoneSmart technology platform.
It comes with a single-use digital flexible ureteroscope with a built-in pressure sensor tip and the StoneSmart Connect Console.
LithoVue Elite is the first ureteroscope system that can monitor intrarenal pressure in real-time during ureteroscopy procedures, said the company.
Boston Scientific Urology senior vice 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.”
Ureteroscopy is a conventional procedure that urologists perform to diagnose and treat several issues related to the urinary tract, most commonly kidney stones.
Fluid irrigation, which is used to maintain a clear visual field during ureteroscopies, may result in elevated intrarenal pressure (IRP).
High IRP may contribute to a wide range of post-operative complications, including systemic inflammatory response syndrome (SIRS), sepsis and renal damage.
Boston Scientific said that its LithoVue Elite System features a high-resolution digital chip and advanced imaging software to provide rapid and sharp image quality with enhanced depth of field compared to the original LithoVue System.
It comes with two programmable buttons on the lightweight, single-use ureteroscope handle, which enables direct control of video and image capture without needing additional staff.
LithoVue Elite’s StoneSmart Connect Console is a compact processing unit that works with existing operating room visualisation towers and endoscopic monitors.
The biomedical engineering company intends to start limited commercialisation of the device in the US, in the coming few weeks.
