最新!又2款创新器械获批上市

Core Viewpoint - The article discusses the recent approval of innovative medical devices by the National Medical Products Administration (NMPA) in China, highlighting the advancements in the field of interventional cardiology and urology [2][3]. Group 1: TaurusTrio Transcatheter Aortic Valve System - The TaurusTrio system, developed by Peijia Medical Technology (Suzhou) Co., Ltd., addresses the challenges of aortic regurgitation (AR) in transcatheter aortic valve replacement (TAVR) procedures, particularly the difficulties in anchoring due to minimal calcification [7][12]. - The system features an integrated positioning key that allows for stable contact with the native valve leaflets, providing a structural solution to the anchoring issue faced by AR patients [12]. - TaurusTrio enhances operational controllability with adjustable bending and rotational capabilities, which significantly reduces the risk of complications and improves release accuracy during procedures [13]. - The design includes a large mesh outlet that preserves future coronary access for patients, reflecting a growing trend in clinical evaluations of TAVR systems [14]. - Peijia Medical, established in 2012, has positioned itself as a key player in the domestic structural heart disease intervention market, with the approval of TaurusTrio expanding its product offerings from stenosis to regurgitation treatments [16]. Group 2: Disposable Sterile Urinary Catheter - The disposable sterile urinary catheter, developed by Taizhou Dubomai Medical Devices Co., Ltd., includes single, double, and triple lumen models tailored for various clinical scenarios, with a core innovation being a polylysine coating that inhibits bacterial growth [18]. - This coating mechanism reduces bacterial adhesion and biofilm formation, representing a significant advancement over traditional sterile catheters that rely solely on standard sterilization methods [18]. - Taizhou Dubomai focuses on innovation in urinary and urological devices, and the approval of this catheter signifies a breakthrough in medical consumables, showcasing a shift towards functional improvements in domestic products [19].