Olympus Gets FDA OK for RenaFlex Single-Use, Flexible Ureteroscope

Olympus has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for RenaFlex, its first single-use ureteroscope system.
 
RenaFlex is used to access and visualize the urinary tract in order to diagnose and treat urinary diseases and disorders like kidney stones. It visualizes organs, cavities, and canals in the urinary tract via transurethral or percutaneous access routes.
 
The ureteroscope, according to Olympus, features a lightweight, ergonomic handle and flexible shaft with stiff, passive bending sections. An advanced camera chip in the distal tip and 120-degree field of view—with auto white balancing and brightness—offers visualization as needed.
 
RenaFlex also touts 270-degree up/down angulation and 9.5 Fr outer diameter with a 3.6 Fr working channel. RenaFlex works in tandem with the compatible CV-S1 Video System Center for flexible single-use endoscopes.
 
“Olympus is your trusted stone management partner and now is positioned to provide access to a broad range of high-quality ureteroscopes, including reusable and single-use flexible scopes to rigid and semi-rigid scopes, powerful lithotripsy solutions and simplified stone removal devices,” said Glen Branconier, VP, business unit leader for Urology/Gynecology at Olympus Corp. of the Americas. “We are excited and privileged to provide urologists and Health Care Providers with the tools they need to confidently care for their patients at any site of care.”
 
Last week, Olympus also announced that Julien Sauvagnargues took over for Nacho Abia as president and CEO of the Olympus Corporation of the Americas.