The LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System is designed for visualising organs, cavities and canals within the urinary tract, including the urethra, bladder, ureter, calyces and renal papillae, through transurethral or percutaneous access routes.
It can be utilised alongside endoscopic accessories to conduct a wide range of diagnostic and therapeutic procedures within the urinary tract, most commonly to treat kidney stones.
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The next-generation LithoVue™ Elite system with intrarenal pressure monitoring allows clinicians to make informed clinical decisions in real time for kidney stone management.
Boston Scientific received 510(k) clearance from the US Food and Drug Administration (FDA) for the LithoVuu Elite system in February 2023.
Need for LithoVue Elite system
Ureteroscopy is a common procedure performed by urologists to examine and treat urinary tract issues, with kidney stones the most prevalent, which can be painful and lead to bleeding or swelling.
During ureteroscopy, fluid irrigation is used to keep a clear visual field, which may cause elevated intrarenal pressure (IRP).
A number of post-operative complications can occur from high IRP, including sepsis, renal damage, pyelovenous backflow and systemic inflammatory response syndrome.
The LithoVue Elite ureteroscope tip with a built-in pressure sensor allows urologists to make real-time pressure-related clinical decisions.
LithoVue Elite system details and features
The LithoVue Elite comprises a single-use digital flexible ureteroscope and the StoneSmart™ Connect Console, which is the LithoVue Elite’s compact processing unit.
LithoVue Elite system’s shaft, extending to 68cm, ensures adequate reach within the urinary tract while maintaining manoeuvrability. With a shaft outer diameter of 9.5 French (F) and an insertion portion width of 7.7F, the device facilitates smooth insertion and minimises patient discomfort.
The working channel, sized at 3.6F with a minimum absolute diameter of 1.15mm, enables the passage of necessary instruments for intervention or specimen retrieval. Furthermore, the extended working length of 82cm enhances accessibility to intricate anatomical structures.
Notably, the ureteroscope features both active and passive deflection capabilities, with a 270° range of active deflection in both directions, empowering urologists to navigate through urinary tracts with precision and ease.
LithoVue Elite system optical details
The ureteroscope has advanced optical features tailored for precise diagnostic and therapeutic interventions in urological procedures. Its expansive 120° diagonal field of view ensures comprehensive visualisation within the urinary tract, facilitating thorough examination and treatment.
The versatile working distance of 2mm to 50mm of digital CMOS imager in the tip of the ureteroscope offers a deep field of view. Equipped with a forward-viewing direction of 0°, the ureteroscope delivers direct and accurate imaging of the urinary tract.
Its high-resolution capability, exceeding 9.81 line pairs per millimetre (lp/mm) at a typical 5mm distance, offers clear and detailed visualisation of urinary tract anatomy and pathology.
Its maximum video latency of 155 milliseconds ensures minimal delay between image capture and display, enabling real-time visualisation during procedures for enhanced procedural efficiency and patient care.
Illumination details
The LithoVue Elite system has an integrated LED light source situated in its handle and a digital CMOS [complementary metal oxide semiconductor] imager in the distal tip of the ureteroscope. The illumination generated by the LED is transmitted to the distal tip lens through a fibre-optic illumination fibre, where the CMOS imager provides the unprocessed image data from the surgical field.
The unprocessed image data travels from the CMOS imager through the handle of the ureteroscope, passes through the umbilicus, and finally reaches the console for processing before being displayed on an external screen.
The two programmable buttons on the lightweight, single-use ureteroscope handle enable direct control of video and image capture.
Technology
The LithoVue Elite system is the first device to be designed on Boston Scientific’s next-generation StoneSmart™ technology platform.
The StoneSmart Connect Console, serving as a compact processing unit, is designed to seamlessly integrate with existing operating room visualisation towers and endoscopic monitors, thereby reducing clutter and the overall capital footprint of the setup.
It simplifies switching between cystoscope and ureteroscope.
Device enhancements from the predecessor LithoVue system
Besides IRP monitoring, the device enhancements feature improved image quality utilising a high-resolution digital chip and advanced proprietary VividVue™ Technology image processing. The system delivers faster and sharper images with a greater depth of field compared to the original LithoVue system.
The two programmable buttons on the handle allow direct control of video and image capture without requiring assistance from staff.
The system is designed with inherent support to potentially integrate with upcoming Boston Scientific devices, ensuring seamless interoperability.
Sustainability features of LithoVue Elite system
Environmental sustainability has been deeply embedded in the development of the LithoVue Elite Single-Use Digital Flexible Ureteroscope.
The design prioritises recyclability, sustainable manufacturing practices and emission reduction throughout the supply chain.
Boston Scientific has partnered with Sharps Compliance, a medical waste management services provider, to minimise the carbon footprint by offering customers a convenient way to recycle or repurpose used LithoVue Elite ureteroscopes and their packaging.
