FDA Clears Single-use Flexible Ureteroscope

Olympus, a global medical technology company committed to making people’s lives healthier, safer and more fulfilling, announced U.S. FDA 510(k) clearance of its first single-use ureteroscope system, RenaFlex™, with full market availability to be announced at a later date.

The RenaFlex single-use flexible ureteroscope system is used to access and visualize the urinary tract to diagnose and treat urinary diseases and disorders, such as kidney stones. The RenaFlex system is intended to visualize organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. The RenaFlex ureteroscope can be used with endotherapeutic accessories to perform diagnostic and therapeutic procedures within the urinary tract.

Regardless of stone size, composition or location, Olympus offers a broad range of stone management solutions to confidently approach every patient or procedure, at any site of care. With the addition of the RenaFlex system, the stone management solution portfolio offers physicians options to be ready for every stone. Key benefits of the RenaFlex Single-use Ureteroscope System include:

• Maneuverability:
  • Lightweight, ergonomic ureteroscope handleⁱ
  • Flexible shaft with stiff and passive bending sectionsⁱⁱ
• Visualization
  • High-quality, consistent visualization during each procedureⁱⁱⁱ
  • Advanced camera chip within the distal tip, 120-degree field of view with auto white balancing and brightness^iv
• Therapeutic Active articulation: 270-degree up/down angulation^v
• 9.5Fr outer diameter with 3.6Fr working channel^v
• Simple set-up that requires minimal O.R. space.

“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, Vice President, 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.”

As with all medical devices please refer to your healthcare provider and the RenaFlex™ Single-use Ureteroscope system Instructions for Use.^vi,vii

The RenaFlex Single-use Ureteroscope works in combination with the compatible CV-S1 Video System Center for flexible Single-use Endoscopes. For safe and proper use follow the manufacturer’s instructions for use handling and operating of the RenaFlex Single-use Ureteroscope and the CV-S1 Video System Center. If used or handled in an improper manner, there is a risk of patient and/or operator injuries, burns, infections, bleeding, and/or perforation, and/or equipment damage.

ⁱ Data on File DN0054301

ⁱⁱ Data on File M160-063R-00
ⁱⁱⁱ Data on File DN0057620
^iv Data on File DN0057516
^v Data on File M160-063R-00
^vi IFU PN0022005_AA
^vii IFU PN0017751_AB