(Olympus: Center Valley, PA) — Olympus, a global medical technology company, has announced U.S. Food and Drug Administration 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 can 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.
Key benefits of the RenaFlex single-use ureteroscope system include:
• Maneuverability
• Lightweight, ergonomic ureteroscope handle
• Flexible shaft with stiff and passive bending sections
• Visualization
• High-quality, consistent visualization during each procedure
• Advanced camera chip within the distal tip, 120° field of view, auto white balancing and brightness
• Therapeutic active articulation: 270° up/down angulation
• 9.5Fr outer diameter with 3.6Fr working channel
• Simple setup that requires minimal operating room space
“Olympus is now positioned to provide access to a broad range of high-quality ureteroscopes, including reusable and single-use flexible scopes to rigid and semirigid scopes, powerful lithotripsy solutions, and simplified stone removal devices,” says Glen Branconier, vice president and business unit leader for urology/gynecology at Olympus. “We are excited and privileged to provide urologists and healthcare providers with the tools they need to confidently care for their patients at any site of care.”
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 handling and operating 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 or operator injuries, burns, infections, bleeding, and perforation, as well as equipment damage. Users should refer to their healthcare provider and the RenaFlex instructions before use.
Visit the urology product page for more information about the complete line of Olympus urology solutions.
منبع: https://www.qualitydigest.com/inside/customer-care-news/olympus-announces-fda-clearance-renaflex-050824.html