Shanghai, China, 10 July 2023 - Recently, MicroPort® Urocare (Jiaxing) Medical Technology Co., Ltd. (hereinafter referred to as "MicroPort® Urocare") successfully completed the certification process of the European Medical Device Regulation MDR (2017/745) for its Disposable Urinary Guidewire, Nitinol Stone Extractor, and Stone Entrapment and Extraction Device.
The approved Disposable Urinary Guidewire combines the advantages of traditional hydrophilic guidewires and zebra guidewires. Its distal end is smoother, softer, and easier to pass through tortuous anatomy in ureters while protecting ureteral tissues from perforation. The specially designed nitinol core with stainless steel wrapping enhances the support of the guidewire, and the PTFE tube enhances maneuverability during the procedure.
The Nitinol Stone Extractor with endoscope adopts a three-wire design, allowing for quick and convenient stone retrieval, thus shortening the learning curve for in-surgery stone manipulation by doctors. The multi-layer sheath design balances strength and flexibility, ensuring durability without hindering the bending of the ureteroscope during the procedure, and it can handle stones in different places of renal calyces.
The Stone Entrapment and Extraction Device features a unique umbrella-like woven structure that can smoothly adapt to various shapes of the ureter, maintaining effective occlusion. The hydrophilic-coated flexible distal end has good passing ability and reduces the risk of ureteral perforation. The extremely slim outer diameter of 2Fr leaves enough space for fiber optics and other stone fragmentation instruments in the working channel of the ureteroscope, simplifying the procedural workflow.
The CE approval for these products indicates that international medical device regulatory authorities have recognized their effectiveness and safety. MicroPort® Urocare will continue to focus on innovative research and development, providing high-quality and affordable medical solutions for more patients worldwide.