Boston Scientific’s Single Use Ureteroscope Gets FDA Clearance
The FDA has given Boston Scientific 510(k) clearance for its LithoVue Elite single-use digital flexible ureteroscope system, the first such system that can monitor intrarenal pressure (IRP) in real-time during a procedure.
Ureteroscopy is a minimally invasive procedure which passes a small telescope through the urethra and bladder and up the ureter to diagnose and address kidney problems such as kidney stones.
During the procedure, the ureter is irrigated with fluid to maintain a clear visual field, which may result in high IRP. High IRP can contribute to a range of post-operative complications including systemic inflammatory response syndrome, sepsis and renal damage.
The built-in pressure sensor on the LithoVue Elite ureteroscope tip provides readings of IRP to allow urologists to mitigate potential complications.
The company plans a limited market release in the U.S. in the coming weeks.