Olympus, a global medical technology company committed to making people's lives healthier, safer and more fulfilling, announced today U.S.

奥林巴斯，一家致力于使人们的生活更健康、更安全、更充实的全球医疗技术公司，今天在美国宣布。

FDA 510(k) clearance of its first single-use ureteroscope system, RenaFlex™, with full market availability to be announced at a later date..

FDA 510（k）批准了其首个一次性输尿管镜系统RenaFlex™，并将于晚些时候宣布全面上市。

Olympus 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

奥林巴斯宣布美国FDA 510（k）批准其首个一次性输尿管镜系统RenaFlex™，并将于晚些时候宣布全面上市

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.

RenaFlex一次性柔性输尿管镜系统用于进入和可视化泌尿道，以诊断和治疗泌尿系统疾病和疾病，如肾结石。RenaFlex系统旨在通过经尿道或经皮途径可视化泌尿道（尿道，膀胱，输尿管，肾盏和肾乳头）中的器官，腔和管。

The RenaFlex ureteroscope can be used with endotherapeutic accessories to perform diagnostic and therapeutic procedures within the urinary tract..

RenaFlex输尿管镜可与内治疗附件一起使用，以在泌尿道内进行诊断和治疗程序。

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.

无论结石大小、成分或位置如何，奥林巴斯都提供了广泛的结石管理解决方案，可以在任何护理场所自信地接近每位患者或程序。随着RenaFlex系统的加入，结石管理解决方案组合为医生提供了为每种结石做好准备的选项。

Key benefits of the RenaFlex Single-use Ureteroscope System include:.

RenaFlex一次性输尿管镜系统的主要优点包括：。

Maneuverability:

机动性：

Lightweight, ergonomic ureteroscope handlei

轻巧、符合人体工程学的输尿管镜手柄

Flexible shaft with stiff and passive bending sectionsii

具有刚性和被动弯曲截面的柔性轴SII

Visualization

可视化

High-quality, consistent visualization during each procedureiii

每个过程中高质量、一致的可视化

Advanced camera chip within the distal tip, 120-degree field of view with auto white balancing and brightnessiv

远端尖端的先进相机芯片，120度视场，具有自动白平衡和亮度IV

Therapeutic Active articulation: 270-degree up/down angulationv

治疗性主动关节：270度上/下角度V

9.5Fr outer diameter with 3.6Fr working channelv

9.5Fr外径，3.6Fr工作通道V

Simple set-up that requires minimal O.R. space.

简单的设置，需要最少的O。R、 空间。

'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.

“奥林巴斯是您值得信赖的结石管理合作伙伴，现在可以使用各种高质量的输尿管镜，包括可重复使用和一次性使用的柔性镜到刚性和半刚性镜，强大的碎石术解决方案和简化的结石清除装置，”奥林巴斯公司泌尿科/妇科业务部门负责人、副总裁格伦·布兰科尼尔（GlenBranconier）说。

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,viiThe RenaFlex Single-use Ureteroscope works in combination with the compatible CV-S1 Video System Center for flexible Single-use Endoscopes.

美洲的。”我们很高兴也很荣幸能为泌尿科医生和医疗保健提供者提供所需的工具，让他们在任何护理地点都能自信地照顾病人。”与所有医疗设备一样，请参阅您的医疗保健提供商和RenaFlex™一次性输尿管镜系统的使用说明。vi，viiThe RenaFlex一次性输尿管镜与兼容的CV-S1视频系统中心结合使用，可用于灵活的一次性内窥镜。

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.Visit the urology product page for more information about the complete line of Olympus urology solutions.About OlympusAt Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling.

为了安全和正确使用，请遵循制造商关于RenaFlex一次性输尿管镜和CV-S1视频系统中心的使用操作说明。如果使用或处理不当，可能会导致患者和/或操作员受伤、烧伤、感染、出血和/或穿孔和/或设备损坏。有关奥林巴斯泌尿外科解决方案完整系列的更多信息，请访问泌尿外科产品页面。关于奥林巴斯，我们致力于使人们的生活更健康、更安全、更充实。

As a global medical technology company, we partner with healthcare professionals to provide solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.For more than 100 years, Olympus has pursued a goal of contributing to society by producing products design.

作为一家全球医疗技术公司，我们与医疗保健专业人员合作，为早期发现、诊断和微创治疗提供解决方案和服务，旨在通过提高目标疾病状态的护理标准来改善患者预后。100多年来，奥林巴斯一直追求通过产品设计为社会做出贡献的目标。