09-13-2022, 05:09 AM
Original Title: Case Analysis of Biliary Stent Product Registration Source: CIRS Medical Device Regulatory Dynamics 1. Overview of Biliary Stent Products Biliary stents (Biliary Stent System), also known as covered biliary stents and biliary stent systems, are usually placed by stent delivery systems (pushers) for the expansion treatment of biliary stenosis or obstruction. According to different stent materials, biliary stents can be divided into plastic stent and expandable metal stent. Plastic stent (stent), its commonly used materials are polyethylene, polytetrafluoroethylene, polyurethane and so on. The shape structure can be straight, single pigtail, double pigtail, etc. (See Figure 2), and can be pre-installed or non-pre-installed. Plastic stents are usually placed by ERCP. Metal stents are usually made of nickel-titanium alloy and can be covered with a membrane, usually a silicone membrane. The shape of the stent is usually straight cylindrical, bell-mouthed cylindrical, S-shaped, etc. (See Figure 3), and some have a recovery loop. The delivery method is generally pre-installed in the conveying system. Can be implanted in an ERCP or PTBD operation, and can be self-expanded by withdrawing from the outer layer of the delivery system during implantation, so as to achieve the purpose of fixing the stenosis part and opening the original stenosis blockage. Biliary stent product features 1) Stents are usually made of polymer materials or metal materials, which can be divided into two categories. 2) There are many types of product structures and shapes, and the user needs to select according to the specific situation. 3) The insertion channel is usually percutaneous transhepatic drainage (PTBD) or endoscopic retrograde cholangiopancreatography (ERCP). Users need to choose the operation plan according to the specific situation, which is reflected in the different lengths of the delivery system. 2. Biliary Stent Listed Manufacturer Information At present, there are 41 biliary stent products approved for listing in China and within the validity period, which belong to 12 registered holders. Among them, there are 8 overseas registration certificate holders with a total of 34 products, and 4 domestic registration certificate holders with a total of 7 products; Cook Medical and Boston Scientific alone have 24 biliary stent products on the market, and Nanjing MicroPort has 4 products, ranking third. From the perspective of product line, only Cook Medical and Boston Scientific are enterprises with full coverage of plastic stents, metal-free stents and metal-covered stents. It is worth noting that in the past three years, only two products have been registered for the first time in Nanjing, and the rest are products that have been on the market for many years or have continued many times. See the attachment at the end of the article for the summary information of the biliary stent registration certificate. 3. Biliary stent classification information The biliary stent classification code is 13-09-06, which is a Class III medical device, and its classification description is as follows: Subdirectory Level 1 Product Category Level 2 Product Category Product Description Intended Use Product Name Example Management Category Passive Implant Device 09 Orthopedic and General Surgery Implant 06 Non-vascular stents typically consist of a stent and/or delivery system. The stent is generally made of metal materials and can be covered with a membrane made of polymer materials. Transluminal implants maintain or restore the integrity of the lumen by providing mechanical support after expansion. It is used to prevent stenosis of non-vascular cavity or reconstruct the structure and/or function of the cavity, and can also be used for internal drainage of bile/pancreatic juice. Biliary stent, urethral stent, intestinal stent, tracheal stent, esophageal stent, prostatic urethral stent, pancreatic duct stent, duodenal stent, colon stent, pyloric stent, tracheostomy stent system, sinus stent III 4. Division of biliary stent registration unit According to the Guiding Principles for the Division of Registration Units of Medical Devices, the principles for the division of registration units of passive medical devices are as follows: Expand the full text (1) Products with different main raw materials of the stent should be divided into different registration units. (2) Covered stents and non-covered stents should be divided into different registration units. (3) The products with different covering materials in the covered stent should be divided into different registration units. (4) Non-degradable stents and biodegradable/absorbable stents should be divided into different registration units. (5) Drug-containing stents and drug-free stents should be divided into different registration units. (6) Products with different drug ingredients and drug proportions in stents should be divided into different registration units.
(7) The products with different coating composition, coating ratio, drug/coating ratio or polymer material composition and intrinsic viscosity related to the main performance of the product contained in the stent should be divided into different registration units. 5. Clinical trial requirements for biliary stents The biliary stent has been listed in the catalogue of clinical exemption. The registration and application process can be exempted from clinical trials and clinical evaluation data can be submitted. However, the clinical trials cannot be exempted if the product has new materials, new structural design, new mechanism of action, drug application, etc. The clinical exemption is described as follows: Serial No. Classification Code Product Name Product Description Category 45913 -09-06 Biliary/Pancreatic/Ureteral Stents Stents are tubular structures made of non-degradable/absorbable polymer materials (such as polyethylene, polyurethane, etc.), which can be equipped with radiopaque markers and other components, can be coated, and can contain conveyor components. It is used to implant the cavity under endoscope, dilate the stenosis of the implantation site, and drain. It is equivalent to the products that have been approved for registration in China. The product composition materials are mature, except for new structural design, new mechanism of action and drug and device combination products. Ⅲ 46013-09-06 Non-vascular self-expanding metallic stents Stents are made of metal with shape memory properties (such as nickel-titanium alloy, etc.), can have radiopaque markers, can have/have no overlay, and can contain delivery components. It is used to dilate the stenosis of non-vascular parts such as esophagus, biliary tract, airway and intestinal tract. It is equivalent to the products that have been approved for registration in China. The product composition materials are mature, except for new structural design, new mechanism of action and drug and device combination products. Ⅲ 6. Technical requirements for biliary stents The technical requirements of biliary stents can be compiled by referring to the standard "GB/T 25304-2010 Special Requirements for Non-vascular Self-expanding Metallic Stents". 7. Biliary stents mainly refer to technical standards or specifications. 7.1 Relevant national and industrial standards Standard No. Standard Name GB/T 25304-Special Requirements for Non-vascular Self-expanding Metallic Stents YY/T 0695-2008 Standard Test Method for Cyclic Potentiodynamic Polarization of Corrosion Susceptibility of Small Implant Devices GB/T 15812. 1 — 2005 Non-intravascular Catheters — Part 1: General Performance Test Methods GB/T 14233.1-2008 Test Methods for Infusion, Transfusion and Injection Equipment for Medical Use Part 1: Chemical Analysis Methods GB/T 14233.2-2005 Test Methods for Infusion, Transfusion and Injection Equipment for Medical Use Part 2: Biological Test Methods GB/T 16886.1-2011 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing GB/T 16886. 5-2017 Biological Evaluation of Medical Devices-Part 5: In vitro Cytotoxicity Test GB/T 16886. 6-2015 Biological evaluation of medical devices-Part 6: Tests for local effects after implantation GB/T 16886. 7-2015 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residues GB/T 16886. 10-2017 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization GB/T 16886.17-2005 Biological Evaluation of Medical Devices-Part 17: Establishment of Allowable Limit of Leachables General requirements for YY/T 06402008 passive surgical implants Note: If there are other new applicable national and industrial standards, they shall be referred to.
7.2 Guiding Principles Category Code Product Name File Name Release or Update Time Management Category 13 Passive Implantable Medical Devices Guidelines for Application Materials for Registration of Passive Implantable Medical Devices 2011/3/24 III 13 Passive Implantable Medical Devices Guidelines for the Application of Shelf Life of Passive Implantable Medical Devices 2013/3/14 III 13 Passive implantable medical devices Guidelines for the preparation of application materials for clinical trial approval of passive implantable medical devices 2018/6/12 III Technical Guidelines for Clinical Evaluation of General Medical Devices 2015/5/19 II, III Guidelines for Clinical Trial Design of General Medical Devices (Draft for Comments) 2017/10/31 II, III General Medical Device Registration Unit Division Guideline 2017/11/23 II, III Technical Guidelines for General Acceptance of Overseas Clinical Trial Data of Medical Devices 2018/1/12 II, III Guidelines for Technical Review of Animal Experimental Research of General Medical Devices Part I: Decision Principles 2019/4/19 II, III Guidelines for Biological Evaluation of General Medical Devices Part 1: General Principles (Exposure Draft) 2018/11/13 II, III Guideline for technical review of validation and validation registration of known leachables determination methods for general medical devices 2019/10/28 II, III Technical Guidelines for Supplementary Data Requirements for Registration Review of General Medical Devices (Draft for Comments) 2019/11/11 II, III Guidelines for Technical Review of Animal Experimental Research on General Medical Devices Part II: Experimental Design, Implementation and Quality Assurance (Exposure Draft) 2019/11/27 II, III Technical Guidelines for Clinical Evaluation of Medical Devices Using General Real-World Data (Exposure Draft) 2019/12/13 II, III Technical Guidelines for Clinical Evaluation of General Medical Devices (Exposure Draft) 2020/1/2 II, III Guidelines for Review of Evaluation Methods and Characterization Techniques for Unknown Leachables in General Medical Devices (Exposure Draft) 2020/6/24 II,titanium bar grade 5, III 8. Main detection mechanism of biliary stent The qualified testing institutes for biliary stent testing mainly include: -Tianjin Medical Equipment Test Center-GB/T 25304 Full Project -Shandong Medical Equipment Product Quality Inspection Center-GB/T 25304 Project -Beijing Medical Equipment Quality Supervision and Inspection Center-GB/T 25304 Project Attachment: Summary of Biliary Stent Registration Certificate Summary of domestic biliary stent registration certificates: Serial Number Manufacturer and Registration Number Product Description Nanjing Minimally Invasive Medical Technology Co., Ltd. (1) The 20153130197 covered biliary stent is a cylindrical stent made of titanium-nickel shape memory alloy meeting the requirements of GB24627, and the surface of the stent is covered with silicone rubber film. Support end shape: straight cylindrical mouth. Stent diameter 6mm, 8mm, 10mm, length 40mm, 50mm, 60mm, 70mm, 80mm. It can be supplied as a single stent or as a stent-preloaded applicator. The implanter consists of a soft head, an inner tube, a positioning developing ring, a middle tube, an outer tube, a liquid injection interface, a front handle, a boosting steel tube and a rear handle. The diameter of the implanter is 2.7 mm and 3 mm, and the length is 1800 mm. The product is sterilized by ethylene oxide and is disposable. Shelf life is two years. The product is suitable for interventional treatment of malignant biliary tract stenosis. (2) The 20163461470 biliary stent is made of nickel-titanium alloy without membrane, in which the nickel content is 54.5-57%. Stent type: straight cylindrical mesh, bell mouth cylindrical mesh, hand-woven structure, can be supplied as a single stent, can also be supplied in the form of stent pre-installed in the implanter.
The implanter is an A-type implanter, which is composed of a soft head, an inner tube, a middle tube, an outer tube, a positioning ring, a handle and a boosting tube. The main manufacturing materials are PVC containing barium sulfate,titanium exhaust tubing, polypropylene, polytetrafluoroethylene, polyetheretherketone, ABS and medical stainless steel. The release auxiliary line material is nylon 6. Ethylene oxide sterilization, disposable product. Shelf life 2 years. It is used for dilatation treatment of biliary tract stenosis or obstruction caused by pathological changes. (3) Guoyazhuzhun 20203130305 Covered Biliary Stent Set This product is composed of an implanter and a stent. The stent is a self-expanding covered stent with a recovery loop and a development mark. The surface is covered with Parylene. The stent material is titanium-nickel shape memory alloy meeting the requirements of GB24627. The covering material is silicone rubber. The stent implanter consists of a soft head, an inner tube, a middle tube, an outer tube, a handle and the like. The product is disposable and sterilized by ethylene oxide. The shelf life of the product is 2 years. The product is suitable for interventional treatment of malignant biliary tract stenosis. (4) GXZZ 20203130346 Biliary Stent Set This product consists of an implanter and a stent. The stent is a self-expanding covered stent with a recovery loop and a development mark. The stent material is TiNi shape memory alloy that meets the requirements of GB24627. The stent implanter consists of a soft head, an inner tube, a middle tube, an outer tube, a handle and the like. The product is disposable and sterilized by ethylene oxide. The shelf life of the product is 2 years. It is used for dilatation treatment of malignant stricture or obstruction of biliary tract caused by pathological changes. 2 Changzhou Zhiye Medical Instrument Research Institute Co., Ltd. (1) Ni-Ti shape memory alloy biliary stent of 20153130862 approved by China Machinery Machinery Co., Ltd. This product is a membraneless biliary stent in human body cavity made of Ni-Ti shape memory alloy, and the stent implanter is an optional part. Support form: straight cylinder type. The product is available in both sterile and non-sterile forms. Sterile products are sterilized by ethylene oxide, and the sterilization period is 5 years. It is mainly used for the treatment of biliary tract stenosis. Youyan Medical Instruments (Beijing) Co., Ltd. (1) The 20193131837 memory alloy biliary stent is a cylindrical reticular structure woven by TiNi alloy wires. Ethylene oxide sterilization, single use. The product is used for biliary obstruction or stenosis caused by various malignant lesions. 4 Changzhou New District Jiasen Medical Stent Equipment Co., Ltd. (1) 20173464610 self-expanding nitinol stent (biliary stent) This product is a grid-type stent woven by nitinol wires conforming to GB/T24627 standard, and the stent is a non-coated straight tube mesh. The product is sterilized by ethylene oxide and is disposable. The product is valid for two years. The product is used for bile duct stricture caused by various malignant lesions. Registration certificate summary of imported biliary stent: Serial Number Manufacturer and Registration Number Product Description 1 Cook Ireland Limited (1) Biliary Stent of National Instrument Infusion 20143135596 This product consists of a stent and a delivery system, and is equipped with a syringe. The material of the stent is nitinol, with four 24-karat gold markers embedded in the stent at the distal and proximal ends. Ethylene oxide sterilization, single use. Shelf life is three years. Biliary stents are designed for the palliative treatment of malignant tumors of the biliary system. (2) Cotton- Huibregtse Biliary Stent Set of the biliary tract stent set for the 20153132365 of the National Instrument. The product is composed of a stent, a guiding catheter, a pushing catheter and a loading sleeve. The stent is made of radiopaque polyethylene; The guide catheter is made of radiopaque Teflon with two tantalum marker rings at the distal end; the push catheter is made of radiopaque polyethylene. Ethylene oxide sterilization, single use. Shelf life is three years. This product is used to drain blocked bile ducts.
(3) Introducer System, a Biliary Stent Set of biliary stent and guiding system for injection 20153132544, is composed of biliary stent and guiding system, which includes guiding catheter and pushing catheter. The biliary stent is made of Teflon; the guide catheter is made of radiopaque Teflon with two tantalum rings at the tip; and the push catheter is made of Teflon. Ethylene oxide sterilization, single use. This product is used to insert biliary stent under endoscope for internal drainage of bile. (4) Zilver 635 Biliary Stent, a 20153132594 biliary stent, consists of a stent and a delivery system. The stent is made of nitinol with four 24 karat gold radiopaque markers evenly spaced at each end. Ethylene oxide sterilization, single use. Shelf life is three years. This product is used to relieve the symptoms of malignant biliary tract tumors. (5) National Machinery Injected into the Cook Ireland Ltd. Of 20153132595 Cook Ireland Ltd. Double-pigtail biliary stent and guide system Solus Double Pigtail Sof-Flex Stent and Introducer System This product is composed of biliary stent, stent guiding catheter, stent pushing catheter and stent straightening catheter. The biliary stent was made of polyurethane, with a tantalum ring marker and five side holes at each end; the stent-guiding catheter, stent-pushing catheter, and stent-straightening catheter were made of polytetrafluoroethylene. Ethylene oxide sterilization, single use. Shelf life is three years. This product is used to insert the biliary tract under endoscope for internal drainage of bile. (6) Cotton-Leung (Amsterdam) Biliary Stent Set biliary stent kit for 20153132726 injection consists of the following components: biliary stent, guiding catheter, stent-loading cannula, and pushing catheter. Product material: biliary stent: polyethylene; stent-guiding catheter and stent-loading sleeve: radiopaque polytetrafluoroethylene (bismuth oxychloride); stent-pushing catheter: radiopaque polyethylene (bismuth oxychloride); radiopaque marker on stent-guiding catheter: metal tantalum. The product is sterilized by ethylene oxide and is disposable. Shelf life is three years. Biliary stent sets are designed to drain blocked bile ducts. (7) Cook Ireland Ltd. Of national machinery injection into 20153133396. Biliary Stent Set & Introducer System Biliary Stent and Guide System is composed of biliary stent, stent guide system, stent loading sleeve, stent pusher and guide wire. Materials: biliary stent: radiopaque polyethylene (bismuth); stent-loading sleeve: radiopaque polytetrafluoroethylene (bismuth); stent-pushing catheter: radiopaque polyethylene (bismuth-); guidewire: 304 stainless steel, Teflon coated. The biliary stent and guide system is designed for endoscopic insertion into the biliary tract for internal drainage of bile. (8) The Evolution Biliary Stent System of biliary stent for 20163461009 injection is composed of stent and delivery system. The stents were double-bell-mouthed and divided into non-covered stent, partially covered stent and fully covered stent. The stent was made of nickel-titanium alloy with platinum core, and the cover was made of silica gel. The partially covered stent and fully covered stent were equipped with grip rings made of ultra-high molecular weight polyethylene, nickel-titanium alloy and PTFE. The delivery system consists of a recovery coil, an inner catheter, a push catheter, a radiopaque marker, a tip, an outer sheath, a trigger wire, a handle and a trigger. Ethylene oxide sterilization, single use. This product is used to relieve the symptoms of malignant biliary tract tumors. (9) The biliary stent Biliary Stent Set of the 2016 3462491 injected by the National Instrument consists of a biliary stent and a stent-loading sleeve.
The material of the biliary stent is radiopaque polytetrafluoroethylene (bismuth oxychloride); the material of the stent loading sleeve is radiopaque polytetrafluoroethylene (Bismuth trioxide). Sterilized by ethylene oxide, nickel titanium wire ,titanium bar gr7, the product is disposable and valid for three years. The product is designed for endoscopic insertion into the biliary tract for internal drainage of bile. (10) Introducer System, a Biliary Stent Set of biliary stent and guiding system for injection 20163132645, consists of biliary stent, stent guiding system, stent loading sleeve and stent pusher. Materials: biliary stent: radiopaque polyethylene; stent guiding catheter and stent loader: radiopaque polytetrafluoroethylene; stent pusher: polytetrafluoroethylene; stent guiding catheter: non-radioactive marker: tantalum ring. Sterilized by ethylene oxide, the product is disposable and valid for 3 years. The biliary stent and guide system is designed for endoscopic insertion into the biliary tract for internal drainage of bile. 2 Boston Scientific Corporation (1) The WallFlex Biliary RX Fully Covered Stent System of the full membrane-covered rapid exchange biliary metal stent system for 20143135239 injection by the National Machinery Co., Ltd. The product is composed of a stent and a delivery system. The stent is woven with metal wires using DFT technology. The outer layer of the metal wire is made of nickel-titanium alloy, and the inner core is made of platinum; the stent body is covered with a Permalume film; the stent is provided with a recovery ring, and the stent can be taken out in the first stent placement process; and both ends of the stent are respectively provided with an expansion port. The delivery system is a rapid exchange type consisting of an outer tube, an inner tube, a distal handle, a proximal handle, and a mandrel. Ethylene oxide sterilization, single use. Shelf life is 24 months. The product is used for relieving bile duct stricture caused by malignant tumor. (2) Wallstent Endoprosthesis with Unistep Plus Delivery System of stents (tracheobronchial stents and biliary stents) with push system in the 20153131304 of national equipment injection. The product consists of stents and UNISTEP. Plus push system composition. The stent is braided from Cond M Elgiloy alloy monofilament or Cond M Elgiloy alloy monofilament with a radiopaque core; the pusher system consists of coaxial tubing with a 0.035 inch (0.89 mm) guidewire. Ethylene oxide sterilization, disposable, shelf life of two years. Tracheobronchial stents are indicated for the treatment of tracheobronchial stenosis caused by malignant tumors. Biliary stent is suitable for the treatment of biliary stricture caused by malignant tumor. (3) WallFlex Biliary Transhepatic Uncovered Stent System of Guoxiang Injectable 20153463910 Uncovered Transhepatic Bile Duct Stent The product consists of self-expanding biliary stent and delivery system. The stent is formed by weaving metal wires by adopting a DFT process, wherein the outer layer of the metal wire is made of nickel-titanium alloy, and the inner core of the metal wire is made of platinum; and two ends of the stent are respectively provided with a flared opening. The product is sterilized by ethylene oxide and is disposable. The WallFlex Uncovered Transhepatic Bile Duct Stent is indicated for the palliative treatment of biliary strictures caused by malignancy. (4) The Advanix Biliary Stent stent of the 20163461628 bile duct stent is a double-pigtail stent with endoscopic visual markers. The manufacturing material is polypropylene containing 20% BiOCl. The surgical operator can load the stent into the delivery system for use as needed. The product is sterilized by ethylene oxide, with a validity period of 2 years and is disposable. Bile duct stents are used to implant a stent into a bile duct to drain the bile duct, to secure the bile duct during healing, or to keep the bile duct open in the case of bile duct strictures or pasty stones.
(5) Advanaix Biliary Stent with Naviflex RX Delivery of Bile Duct Stent (equipped with NaviFlex RX Delivery System) for 20163461627 Injection by National Equipment System Advanix bile duct stents include a mid-curved stent and a duodenal curved stent with endoscopic visual markers. The NaviFlex RX Delivery System consists of a guide catheter with tantalum markers and a push tube. The manufacturing materials are: stent: polyethylene containing 22% (BiO) 2CO3 (10Fr)/30% BiOCl (7Fr8.5Fr); guiding catheter: polyvinylidene fluoride; pushing tube: Pebax6333. The Advanix Biliary Stent using the NaviFlex RX Delivery System is available in two ways: 1) the stent is pre-loaded into the delivery system, and 2) the stent and delivery system are in separate packages. If necessary. The operator can reposition the stent by pre-loading the system. The product is sterilized by ethylene oxide. The Biliary Stent (with NaviFlex RX Delivery System) is used to implant a stent into the bile duct for drainage of the bile duct, to secure the bile duct during healing, or to keep the duct open in the case of biliary strictures or pasty stones. (6) The Wallstent RX Biliary Endoprosthesis Biliary Stent System with and without Permalume of rapid exchange biliary metallic stents with/without membrane in the 3462720 of 2016 was injected by the National Instrument. Covering This product consists of a stand and a push system. The stent was made of a tubular mesh woven from a Co-based alloy monofilament containing tantalum wire, with/without Permalume covering, the covering material was silicone polymer, and the two ends of the covered stent were bare metal braids with a length of about 5 mm. Push system is made of polyether-based polyurethane resin, PEEK, Pebax, polyurethane, nylon 12, low density polyethylene, nickel titanium alloy, high density polyethylene and other materials, with radiopaque platinum iridium alloy marker tape. Sterilized by ethylene oxide, the product has a validity period of 19 months and is disposable. The product is suitable for treating bile duct stricture caused by malignant tumor. (7) The Corporation Flexima Biliary Stent of the integrated biliary stent injected into the 20163462869 of the national equipment. The product is composed of a pre-installed stent and a conveyor. The stent was made of polyurethane and 40% barium sulfate, and the distal 1.5 cm fixed part was coated with Hydro-plus coating; the delivery device included a guide catheter and a push catheter. Ethylene oxide sterilization, single use. This product is used to implant a stent into the bile duct to drain the bile duct, to immobilize the bile duct during healing, or to keep the duct open in the presence of bile duct strictures or pasty stones. (8) The WallFlex Biliary RX Fully Covered Stent System RMV of the fully covered stent system for the 20163464497 of the bile duct injected by the National Equipment Company. The product consists of a pre-installed self-dilating metal stent for the bile duct and a push system. The stent is made of Nitinol and platinum and is molded into a cylindrical mesh structure covered with Permalume (dimethyl silicone) with a Nitinol recovery ring. There is an expansion port at each end of the stent to prevent it from moving after the stent is placed in the bile duct. The pushing system consists of a marking ring, an outer tube, an inner tube, a distal end handle, a proximal end handle, a mandrel and the like. Ethylene oxide sterilization, single use. Valid for 24 months. Bile duct covered stent system is suitable for palliative treatment of bile duct stricture caused by malignant tumors and benign bile duct stricture.
(9) Wallstent Endoscopic Biliary Endoprosthesis with Permalume Covering of metal stent for biliary tract covered with 20163465079 by Guoji. The product consists of implantable metal stent and UNISTEP. Plus push system composition. The stent is composed of biomedical superalloy monofilaments interwoven into a network of tubes and coated with silicone polymers (Permalume). Each end of the covered stent had an uncovered portion of about 5 mm in length. The pushing system is mainly composed of a coaxial tube, and the inner tube cavity of the coaxial tube can pass through a tube with the diameter of 0. 89mm （0. 035 "). Ethylene oxide sterilization, single use. The shelf life of the product is two years. The product is used for treating bile duct stricture caused by malignant tumor. (10) Percuflex Biliary Stent of plastic biliary stent injected with 20173461815 by Guoji Machinery Co., Ltd. This product is a plastic biliary stent, which can be packaged separately or packaged with a conveyor system. The biliary stent is made of EVA resin, bismuth subcarbonate, and white dye; the delivery device includes a push tube and a guide catheter. Ethylene oxide sterilization, disposable, valid for three years. The product is suitable for the treatment of biliary stricture. (11) Wallstent Biliary Endoscopic Biliary Endoprosthesis Uncovered of biliary metal stent with push system for injection 20173466397 of China National Machinery Co., Ltd. The product consists of stent and Unistep Plus push system. The stent is composed of a cobalt-based alloy, and the core wire is tantalum. The pusher system consists primarily of coaxial tubing with a 0.89 mm (0.035) guidewire through the lumen of the inner tube. The product can be inserted through the working channel of a therapeutic or diagnostic duodenoscope (minimum channel diameter 3.2 mm). Radiation sterilization, single use. Shelf life 2 years. The product is suitable for treating bile duct stricture caused by malignant tumor. (12) The Wallflex Biliary RX Uncovered Stent System of the non-membrane rapid exchange biliary tract metal stent system for 20173466228 injection of China Machinery Equipment Co., Ltd. The product is composed of stent and delivery system. The stent is made of metal wire with DFT process. The outer layer of the metal wire is nickel-titanium alloy. The inner core is platinum; the stent has a recovery ring that allows the stent to be removed during initial stent placement; and the stent has an expansion port at each end. The delivery system is a rapid exchange type consisting of an outer tube, an inner tube, a distal handle, a proximal handle, and a mandrel. Ethylene oxide sterilization, single use. Shelf life is 24 months. The product is used for palliative treatment of bile duct stricture caused by malignant tumor. (13) Transhepatic Biliary Tract Stent System Placehit Biliary Wallstent for 20173466830 Injected by National Instrument The product is composed of self-expanding stent and pushing system. The stent is braided with Elgiloy alloy wire and gold-plated tungsten wire; the push system can be inserted through the liver with either a 0.035- or 0.038-inch guidewire. Ethylene oxide sterilization, single use. The product is valid for 2 years. This product is used to maintain bile duct patency in patients with the following malignancies: a. Pancreatic cancer patients with tumor compression of the biliary system ；b. Patients with biliary tract obstruction caused by tumor ；c. Due to gallbladder cancer Patients with extrahepatic biliary obstruction caused by metastasis or ampullary carcinoma.
(14) The Wallflex Biliary RX Partially Covered Stent System of the partial membrane-covered rapid exchange biliary metal stent system injected into the 20193132211 by the National Machinery Company. The product consists of a stent and a delivery system. The stent is made of metal wires with DFT technology. The outer layer of the metal wire is made of nickel-titanium alloy, and the inner core is made of platinum; a part of the film is permalume (silicone resin); a recovery ring is arranged on the stent, so that the stent can be taken out during the first stent placement process; and an expansion port is arranged at each end of the stent. The delivery system is a rapid exchange type consisting of an outer tube, an inner tube, a distal handle, a proximal handle, and a mandrel. Ethylene oxide sterilization, single use. Shelf life 2 years. The product is used for palliative treatment of bile duct stricture caused by malignant tumor. 3奥林巴斯医疗株式会社オリンパスメディカルシステムズ株式会社 (1) Bile duct stent for injecting 20153130472 This product is composed of stent and auxiliary insertion instrument. Auxiliary insertion devices include pushers (push tubes, guide tubes), protective sleeves, and guide wires. The stent material is mainly composed of a high-density polyethylene low-density polyethylene mixture, a tetrafluoroethylene-hexafluoropropylene copolymer, polyamide, a tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer, stainless steel and the like, and the pusher is mainly composed of polytetrafluoroethylene, polyethylene and the like. The radiopaque substances are barium sulfate, bismuth oxide, and tungsten. The color of the bracket is yellow, green, blue and white. The product is sterilized by ethylene oxide. Biliary stent and pusher MAJ-1416/1417/1418/1419/1420/1421/1422 are disposable products, and other models/specifications can be reused. The shelf life of the disposable product is 3-5 years. The product is used in combination with the endoscope designated by the company. The biliary stent is placed in the bile duct through the endoscope to discharge bile. (2) The biliary stent for injecting 20183130497 into the biliary duct has pre-installed and non-pre-installed products. The preassembled product consists of a bracket, a pusher and a protective sleeve component. Non-preassembled products consist of brackets, protective sleeves or straighteners. There are also pusher models that are individually packaged. The scaffold is made of ethylene-vinyl acetate copolymer and bismuth oxide, and contains phthalocyanine blue dye. The product is sterilized by ethylene oxide and is disposable, and the sterilization period is 3 years. This product is to place a biliary stent in the bile duct through the endoscope to discharge bile. 4Sewoon Medical Co., Ltd. (1) Biliary Stent for 20163461394 Injection The stent is made of nickel-titanium alloy and consists of stent, radiopaque marker on the stent, radiopaque marker on the catheter, outer sheath, outer sheath tube, inner shaft, inner tube, olive-shaped tip, inner shaft handle, outer sheath handle and reduction device. The product is extinguished by ethylene oxide, is disposable and has a validity period of 3 years. The product is used for the treatment of biliary tract obstruction caused by malignant tumors and other reasons, which is inserted into the lesion site to help it become smooth. (2) Biliary Covered Stent of biliary tract covered stent injected into 20163462224 by Guoji Machinery Co., Ltd. The product consists of stent and transmission system. The stent is made of nickel-titanium alloy with platinum radiopaque markers and a polypropylene recovery noose, and is covered with a silicone rubber membrane. The delivery system consists of an outer sheath, an outer sheath tube, an inner shaft, an inner tube, an olive-shaped head end, a handle of the inner shaft, a handle of the outer sheath, a reset device and a visual marker. Sterilized by ethylene oxide, the product is disposable and valid for 3 years. The product is used for the treatment of biliary tract obstruction caused by malignant tumors and other reasons, which is inserted into the lesion site to help it become smooth.
5 S & G Biotech Inc. Of Aisji Biotechnology Co., Ltd. (1) The EGIS Biliary Stent of biliary stent injected into 20193132087 by Guoji Machinery Co., Ltd. consists of a single-layer bare stent and a delivery system. The stent consists of a component and a tracer. The component of the stent is made of nickel-titanium alloy material conforming to the requirements of GB24627 standard. The tracer is made of tungsten (gold-plated) material with a purity of 99.99%. The delivery system consists of a pusher, a sleeve, an olive end, a tracer, a catheter and a handle. The pusher is made of 304 L stainless steel and polypropylene material. The cannula is made of Teflon, 304 L stainless steel, nylon elastomer material and phthalocyanine blue, the olive end is made of polyvinyl chloride material, the tracer is made of tungsten and silicone material, the catheter is of polyetheretherketone material and the handle is of ABS material. Sterilized package, disposable. Shelf life is two years. The delivery system is used to insert the stent (self-expansion) into the lesion site to expand the biliary tract, treat biliary obstruction, and make the bile secretion of the obstruction site unobstructed. 6Angiomed GmbH＆Co.Medizintechnik KG (1) Biliary Stent for Injection of 20163462900 Biliary Stent consists of a delivery system and a stent. The stent was made of Nitinol, and there were four radiopaque tantalum markers at the proximal and distal ends of the stent. The delivery system is provided with platinum-iridium alloy radiopaque markers and consists of an outer catheter, an inner catheter, a catheter tip, a Luer connector, a safety clip wing, a safety clip, a handle, a conversion wing, a trigger, a pullback device and a guide rod. The product is sterilized by ethylene oxide and is disposable. The product is valid for 3 years. The product is suitable for treating biliary stricture caused by malignant tumor. 7 Wilson-Cook Medical Incorporated (1) Metal Biliary Stent System for 20173465088 Injection Zilver Expandable Metal Biliary Stent System Metal Biliary Stent System consists of stent and delivery system. The stand is made of Nitinol and has four 24-karat gold markers on each end; the delivery system consists of a head end A sheath tube, a pusher, a handle and a metal sleeve. Ethylene oxide sterilization, valid for 3 years, disposable. Metallic biliary stent systems are used to relieve symptoms of malignant biliary tract tumors. 8 Korea Maytag M. I. Tech Co., Ltd. (1) Biliary stent HANAROSTENT Biliary Stent for injection 20183461814 of national equipment The product consists of a pre-assembled stent and a pusher. The pusher includes a push rod and an outer sheath. The stent is woven into a cylindrical shape by nickel-titanium alloy wires. Ethylene oxide sterilization, single use. The sterile validity period of the product is 3 years. The product is used for dilating biliary stricture caused by benign and malignant tumors. 9Taewoong Medical Co.,Ltd. (1) National Instrument Injection 20163462793 Biliary Tract Uncovered Stent Niti-S Biliary Uncovered Stent This product consists of a handle, a Y-shaped connector, a pusher, an outer sheath, an intermediate catheter, a radiation-detectable marker, a yellow marker, a bindings, an inner catheter, a tip and a stent. The stent was made of nickel-titanium alloy, and the radiolabeling materials were 316 L stainless steel and platinum-iridium alloy. The delivery system is divided into endoscopic delivery system and percutaneous delivery system, which is made of ABS, 304 stainless steel, PTFE, PEBAX, platinum-iridium alloy, nylon, polyolefin, polyetheretherketone, tungsten and other materials. The stent is divided into S-type stent and D-type stent according to different weaving methods. Ethylene oxide sterilization, disposable product. Valid for 3 years. The product is mainly used for biliary stricture caused by primary and/or secondary malignant/benign tumors to help restore the smooth of the stricture.
(2) Niti-S Biliary Covered Stent, a 20163462808 biliary covered stent, is composed of a stent and a delivery system. The braiding type of the stent is S-type, the main body material is nickel-titanium alloy, the ray detectability marker material is 316L stainless steel and platinum-iridium alloy, the coating material is silicone, and the stent is provided with nylon material strings. The delivery system is divided into an endoscope delivery system and a percutaneous delivery system and consists of a handle, a Y-shaped connector, a pusher, an outer sheath, an intermediate catheter, a ray detectable marker, a yellow marker,Titanium welding pipe, an bindings, an inner catheter and a tip. Ethylene oxide sterilization, disposable product. The product is mainly used for biliary stricture caused by primary and/or secondary malignant/benign tumors to help restore the smooth of the stricture. END Return to Sohu to see more Responsible Editor:. yunchtitanium.com
(7) The products with different coating composition, coating ratio, drug/coating ratio or polymer material composition and intrinsic viscosity related to the main performance of the product contained in the stent should be divided into different registration units. 5. Clinical trial requirements for biliary stents The biliary stent has been listed in the catalogue of clinical exemption. The registration and application process can be exempted from clinical trials and clinical evaluation data can be submitted. However, the clinical trials cannot be exempted if the product has new materials, new structural design, new mechanism of action, drug application, etc. The clinical exemption is described as follows: Serial No. Classification Code Product Name Product Description Category 45913 -09-06 Biliary/Pancreatic/Ureteral Stents Stents are tubular structures made of non-degradable/absorbable polymer materials (such as polyethylene, polyurethane, etc.), which can be equipped with radiopaque markers and other components, can be coated, and can contain conveyor components. It is used to implant the cavity under endoscope, dilate the stenosis of the implantation site, and drain. It is equivalent to the products that have been approved for registration in China. The product composition materials are mature, except for new structural design, new mechanism of action and drug and device combination products. Ⅲ 46013-09-06 Non-vascular self-expanding metallic stents Stents are made of metal with shape memory properties (such as nickel-titanium alloy, etc.), can have radiopaque markers, can have/have no overlay, and can contain delivery components. It is used to dilate the stenosis of non-vascular parts such as esophagus, biliary tract, airway and intestinal tract. It is equivalent to the products that have been approved for registration in China. The product composition materials are mature, except for new structural design, new mechanism of action and drug and device combination products. Ⅲ 6. Technical requirements for biliary stents The technical requirements of biliary stents can be compiled by referring to the standard "GB/T 25304-2010 Special Requirements for Non-vascular Self-expanding Metallic Stents". 7. Biliary stents mainly refer to technical standards or specifications. 7.1 Relevant national and industrial standards Standard No. Standard Name GB/T 25304-Special Requirements for Non-vascular Self-expanding Metallic Stents YY/T 0695-2008 Standard Test Method for Cyclic Potentiodynamic Polarization of Corrosion Susceptibility of Small Implant Devices GB/T 15812. 1 — 2005 Non-intravascular Catheters — Part 1: General Performance Test Methods GB/T 14233.1-2008 Test Methods for Infusion, Transfusion and Injection Equipment for Medical Use Part 1: Chemical Analysis Methods GB/T 14233.2-2005 Test Methods for Infusion, Transfusion and Injection Equipment for Medical Use Part 2: Biological Test Methods GB/T 16886.1-2011 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing GB/T 16886. 5-2017 Biological Evaluation of Medical Devices-Part 5: In vitro Cytotoxicity Test GB/T 16886. 6-2015 Biological evaluation of medical devices-Part 6: Tests for local effects after implantation GB/T 16886. 7-2015 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residues GB/T 16886. 10-2017 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization GB/T 16886.17-2005 Biological Evaluation of Medical Devices-Part 17: Establishment of Allowable Limit of Leachables General requirements for YY/T 06402008 passive surgical implants Note: If there are other new applicable national and industrial standards, they shall be referred to.
7.2 Guiding Principles Category Code Product Name File Name Release or Update Time Management Category 13 Passive Implantable Medical Devices Guidelines for Application Materials for Registration of Passive Implantable Medical Devices 2011/3/24 III 13 Passive Implantable Medical Devices Guidelines for the Application of Shelf Life of Passive Implantable Medical Devices 2013/3/14 III 13 Passive implantable medical devices Guidelines for the preparation of application materials for clinical trial approval of passive implantable medical devices 2018/6/12 III Technical Guidelines for Clinical Evaluation of General Medical Devices 2015/5/19 II, III Guidelines for Clinical Trial Design of General Medical Devices (Draft for Comments) 2017/10/31 II, III General Medical Device Registration Unit Division Guideline 2017/11/23 II, III Technical Guidelines for General Acceptance of Overseas Clinical Trial Data of Medical Devices 2018/1/12 II, III Guidelines for Technical Review of Animal Experimental Research of General Medical Devices Part I: Decision Principles 2019/4/19 II, III Guidelines for Biological Evaluation of General Medical Devices Part 1: General Principles (Exposure Draft) 2018/11/13 II, III Guideline for technical review of validation and validation registration of known leachables determination methods for general medical devices 2019/10/28 II, III Technical Guidelines for Supplementary Data Requirements for Registration Review of General Medical Devices (Draft for Comments) 2019/11/11 II, III Guidelines for Technical Review of Animal Experimental Research on General Medical Devices Part II: Experimental Design, Implementation and Quality Assurance (Exposure Draft) 2019/11/27 II, III Technical Guidelines for Clinical Evaluation of Medical Devices Using General Real-World Data (Exposure Draft) 2019/12/13 II, III Technical Guidelines for Clinical Evaluation of General Medical Devices (Exposure Draft) 2020/1/2 II, III Guidelines for Review of Evaluation Methods and Characterization Techniques for Unknown Leachables in General Medical Devices (Exposure Draft) 2020/6/24 II,titanium bar grade 5, III 8. Main detection mechanism of biliary stent The qualified testing institutes for biliary stent testing mainly include: -Tianjin Medical Equipment Test Center-GB/T 25304 Full Project -Shandong Medical Equipment Product Quality Inspection Center-GB/T 25304 Project -Beijing Medical Equipment Quality Supervision and Inspection Center-GB/T 25304 Project Attachment: Summary of Biliary Stent Registration Certificate Summary of domestic biliary stent registration certificates: Serial Number Manufacturer and Registration Number Product Description Nanjing Minimally Invasive Medical Technology Co., Ltd. (1) The 20153130197 covered biliary stent is a cylindrical stent made of titanium-nickel shape memory alloy meeting the requirements of GB24627, and the surface of the stent is covered with silicone rubber film. Support end shape: straight cylindrical mouth. Stent diameter 6mm, 8mm, 10mm, length 40mm, 50mm, 60mm, 70mm, 80mm. It can be supplied as a single stent or as a stent-preloaded applicator. The implanter consists of a soft head, an inner tube, a positioning developing ring, a middle tube, an outer tube, a liquid injection interface, a front handle, a boosting steel tube and a rear handle. The diameter of the implanter is 2.7 mm and 3 mm, and the length is 1800 mm. The product is sterilized by ethylene oxide and is disposable. Shelf life is two years. The product is suitable for interventional treatment of malignant biliary tract stenosis. (2) The 20163461470 biliary stent is made of nickel-titanium alloy without membrane, in which the nickel content is 54.5-57%. Stent type: straight cylindrical mesh, bell mouth cylindrical mesh, hand-woven structure, can be supplied as a single stent, can also be supplied in the form of stent pre-installed in the implanter.
The implanter is an A-type implanter, which is composed of a soft head, an inner tube, a middle tube, an outer tube, a positioning ring, a handle and a boosting tube. The main manufacturing materials are PVC containing barium sulfate,titanium exhaust tubing, polypropylene, polytetrafluoroethylene, polyetheretherketone, ABS and medical stainless steel. The release auxiliary line material is nylon 6. Ethylene oxide sterilization, disposable product. Shelf life 2 years. It is used for dilatation treatment of biliary tract stenosis or obstruction caused by pathological changes. (3) Guoyazhuzhun 20203130305 Covered Biliary Stent Set This product is composed of an implanter and a stent. The stent is a self-expanding covered stent with a recovery loop and a development mark. The surface is covered with Parylene. The stent material is titanium-nickel shape memory alloy meeting the requirements of GB24627. The covering material is silicone rubber. The stent implanter consists of a soft head, an inner tube, a middle tube, an outer tube, a handle and the like. The product is disposable and sterilized by ethylene oxide. The shelf life of the product is 2 years. The product is suitable for interventional treatment of malignant biliary tract stenosis. (4) GXZZ 20203130346 Biliary Stent Set This product consists of an implanter and a stent. The stent is a self-expanding covered stent with a recovery loop and a development mark. The stent material is TiNi shape memory alloy that meets the requirements of GB24627. The stent implanter consists of a soft head, an inner tube, a middle tube, an outer tube, a handle and the like. The product is disposable and sterilized by ethylene oxide. The shelf life of the product is 2 years. It is used for dilatation treatment of malignant stricture or obstruction of biliary tract caused by pathological changes. 2 Changzhou Zhiye Medical Instrument Research Institute Co., Ltd. (1) Ni-Ti shape memory alloy biliary stent of 20153130862 approved by China Machinery Machinery Co., Ltd. This product is a membraneless biliary stent in human body cavity made of Ni-Ti shape memory alloy, and the stent implanter is an optional part. Support form: straight cylinder type. The product is available in both sterile and non-sterile forms. Sterile products are sterilized by ethylene oxide, and the sterilization period is 5 years. It is mainly used for the treatment of biliary tract stenosis. Youyan Medical Instruments (Beijing) Co., Ltd. (1) The 20193131837 memory alloy biliary stent is a cylindrical reticular structure woven by TiNi alloy wires. Ethylene oxide sterilization, single use. The product is used for biliary obstruction or stenosis caused by various malignant lesions. 4 Changzhou New District Jiasen Medical Stent Equipment Co., Ltd. (1) 20173464610 self-expanding nitinol stent (biliary stent) This product is a grid-type stent woven by nitinol wires conforming to GB/T24627 standard, and the stent is a non-coated straight tube mesh. The product is sterilized by ethylene oxide and is disposable. The product is valid for two years. The product is used for bile duct stricture caused by various malignant lesions. Registration certificate summary of imported biliary stent: Serial Number Manufacturer and Registration Number Product Description 1 Cook Ireland Limited (1) Biliary Stent of National Instrument Infusion 20143135596 This product consists of a stent and a delivery system, and is equipped with a syringe. The material of the stent is nitinol, with four 24-karat gold markers embedded in the stent at the distal and proximal ends. Ethylene oxide sterilization, single use. Shelf life is three years. Biliary stents are designed for the palliative treatment of malignant tumors of the biliary system. (2) Cotton- Huibregtse Biliary Stent Set of the biliary tract stent set for the 20153132365 of the National Instrument. The product is composed of a stent, a guiding catheter, a pushing catheter and a loading sleeve. The stent is made of radiopaque polyethylene; The guide catheter is made of radiopaque Teflon with two tantalum marker rings at the distal end; the push catheter is made of radiopaque polyethylene. Ethylene oxide sterilization, single use. Shelf life is three years. This product is used to drain blocked bile ducts.
(3) Introducer System, a Biliary Stent Set of biliary stent and guiding system for injection 20153132544, is composed of biliary stent and guiding system, which includes guiding catheter and pushing catheter. The biliary stent is made of Teflon; the guide catheter is made of radiopaque Teflon with two tantalum rings at the tip; and the push catheter is made of Teflon. Ethylene oxide sterilization, single use. This product is used to insert biliary stent under endoscope for internal drainage of bile. (4) Zilver 635 Biliary Stent, a 20153132594 biliary stent, consists of a stent and a delivery system. The stent is made of nitinol with four 24 karat gold radiopaque markers evenly spaced at each end. Ethylene oxide sterilization, single use. Shelf life is three years. This product is used to relieve the symptoms of malignant biliary tract tumors. (5) National Machinery Injected into the Cook Ireland Ltd. Of 20153132595 Cook Ireland Ltd. Double-pigtail biliary stent and guide system Solus Double Pigtail Sof-Flex Stent and Introducer System This product is composed of biliary stent, stent guiding catheter, stent pushing catheter and stent straightening catheter. The biliary stent was made of polyurethane, with a tantalum ring marker and five side holes at each end; the stent-guiding catheter, stent-pushing catheter, and stent-straightening catheter were made of polytetrafluoroethylene. Ethylene oxide sterilization, single use. Shelf life is three years. This product is used to insert the biliary tract under endoscope for internal drainage of bile. (6) Cotton-Leung (Amsterdam) Biliary Stent Set biliary stent kit for 20153132726 injection consists of the following components: biliary stent, guiding catheter, stent-loading cannula, and pushing catheter. Product material: biliary stent: polyethylene; stent-guiding catheter and stent-loading sleeve: radiopaque polytetrafluoroethylene (bismuth oxychloride); stent-pushing catheter: radiopaque polyethylene (bismuth oxychloride); radiopaque marker on stent-guiding catheter: metal tantalum. The product is sterilized by ethylene oxide and is disposable. Shelf life is three years. Biliary stent sets are designed to drain blocked bile ducts. (7) Cook Ireland Ltd. Of national machinery injection into 20153133396. Biliary Stent Set & Introducer System Biliary Stent and Guide System is composed of biliary stent, stent guide system, stent loading sleeve, stent pusher and guide wire. Materials: biliary stent: radiopaque polyethylene (bismuth); stent-loading sleeve: radiopaque polytetrafluoroethylene (bismuth); stent-pushing catheter: radiopaque polyethylene (bismuth-); guidewire: 304 stainless steel, Teflon coated. The biliary stent and guide system is designed for endoscopic insertion into the biliary tract for internal drainage of bile. (8) The Evolution Biliary Stent System of biliary stent for 20163461009 injection is composed of stent and delivery system. The stents were double-bell-mouthed and divided into non-covered stent, partially covered stent and fully covered stent. The stent was made of nickel-titanium alloy with platinum core, and the cover was made of silica gel. The partially covered stent and fully covered stent were equipped with grip rings made of ultra-high molecular weight polyethylene, nickel-titanium alloy and PTFE. The delivery system consists of a recovery coil, an inner catheter, a push catheter, a radiopaque marker, a tip, an outer sheath, a trigger wire, a handle and a trigger. Ethylene oxide sterilization, single use. This product is used to relieve the symptoms of malignant biliary tract tumors. (9) The biliary stent Biliary Stent Set of the 2016 3462491 injected by the National Instrument consists of a biliary stent and a stent-loading sleeve.
The material of the biliary stent is radiopaque polytetrafluoroethylene (bismuth oxychloride); the material of the stent loading sleeve is radiopaque polytetrafluoroethylene (Bismuth trioxide). Sterilized by ethylene oxide, nickel titanium wire ,titanium bar gr7, the product is disposable and valid for three years. The product is designed for endoscopic insertion into the biliary tract for internal drainage of bile. (10) Introducer System, a Biliary Stent Set of biliary stent and guiding system for injection 20163132645, consists of biliary stent, stent guiding system, stent loading sleeve and stent pusher. Materials: biliary stent: radiopaque polyethylene; stent guiding catheter and stent loader: radiopaque polytetrafluoroethylene; stent pusher: polytetrafluoroethylene; stent guiding catheter: non-radioactive marker: tantalum ring. Sterilized by ethylene oxide, the product is disposable and valid for 3 years. The biliary stent and guide system is designed for endoscopic insertion into the biliary tract for internal drainage of bile. 2 Boston Scientific Corporation (1) The WallFlex Biliary RX Fully Covered Stent System of the full membrane-covered rapid exchange biliary metal stent system for 20143135239 injection by the National Machinery Co., Ltd. The product is composed of a stent and a delivery system. The stent is woven with metal wires using DFT technology. The outer layer of the metal wire is made of nickel-titanium alloy, and the inner core is made of platinum; the stent body is covered with a Permalume film; the stent is provided with a recovery ring, and the stent can be taken out in the first stent placement process; and both ends of the stent are respectively provided with an expansion port. The delivery system is a rapid exchange type consisting of an outer tube, an inner tube, a distal handle, a proximal handle, and a mandrel. Ethylene oxide sterilization, single use. Shelf life is 24 months. The product is used for relieving bile duct stricture caused by malignant tumor. (2) Wallstent Endoprosthesis with Unistep Plus Delivery System of stents (tracheobronchial stents and biliary stents) with push system in the 20153131304 of national equipment injection. The product consists of stents and UNISTEP. Plus push system composition. The stent is braided from Cond M Elgiloy alloy monofilament or Cond M Elgiloy alloy monofilament with a radiopaque core; the pusher system consists of coaxial tubing with a 0.035 inch (0.89 mm) guidewire. Ethylene oxide sterilization, disposable, shelf life of two years. Tracheobronchial stents are indicated for the treatment of tracheobronchial stenosis caused by malignant tumors. Biliary stent is suitable for the treatment of biliary stricture caused by malignant tumor. (3) WallFlex Biliary Transhepatic Uncovered Stent System of Guoxiang Injectable 20153463910 Uncovered Transhepatic Bile Duct Stent The product consists of self-expanding biliary stent and delivery system. The stent is formed by weaving metal wires by adopting a DFT process, wherein the outer layer of the metal wire is made of nickel-titanium alloy, and the inner core of the metal wire is made of platinum; and two ends of the stent are respectively provided with a flared opening. The product is sterilized by ethylene oxide and is disposable. The WallFlex Uncovered Transhepatic Bile Duct Stent is indicated for the palliative treatment of biliary strictures caused by malignancy. (4) The Advanix Biliary Stent stent of the 20163461628 bile duct stent is a double-pigtail stent with endoscopic visual markers. The manufacturing material is polypropylene containing 20% BiOCl. The surgical operator can load the stent into the delivery system for use as needed. The product is sterilized by ethylene oxide, with a validity period of 2 years and is disposable. Bile duct stents are used to implant a stent into a bile duct to drain the bile duct, to secure the bile duct during healing, or to keep the bile duct open in the case of bile duct strictures or pasty stones.
(5) Advanaix Biliary Stent with Naviflex RX Delivery of Bile Duct Stent (equipped with NaviFlex RX Delivery System) for 20163461627 Injection by National Equipment System Advanix bile duct stents include a mid-curved stent and a duodenal curved stent with endoscopic visual markers. The NaviFlex RX Delivery System consists of a guide catheter with tantalum markers and a push tube. The manufacturing materials are: stent: polyethylene containing 22% (BiO) 2CO3 (10Fr)/30% BiOCl (7Fr8.5Fr); guiding catheter: polyvinylidene fluoride; pushing tube: Pebax6333. The Advanix Biliary Stent using the NaviFlex RX Delivery System is available in two ways: 1) the stent is pre-loaded into the delivery system, and 2) the stent and delivery system are in separate packages. If necessary. The operator can reposition the stent by pre-loading the system. The product is sterilized by ethylene oxide. The Biliary Stent (with NaviFlex RX Delivery System) is used to implant a stent into the bile duct for drainage of the bile duct, to secure the bile duct during healing, or to keep the duct open in the case of biliary strictures or pasty stones. (6) The Wallstent RX Biliary Endoprosthesis Biliary Stent System with and without Permalume of rapid exchange biliary metallic stents with/without membrane in the 3462720 of 2016 was injected by the National Instrument. Covering This product consists of a stand and a push system. The stent was made of a tubular mesh woven from a Co-based alloy monofilament containing tantalum wire, with/without Permalume covering, the covering material was silicone polymer, and the two ends of the covered stent were bare metal braids with a length of about 5 mm. Push system is made of polyether-based polyurethane resin, PEEK, Pebax, polyurethane, nylon 12, low density polyethylene, nickel titanium alloy, high density polyethylene and other materials, with radiopaque platinum iridium alloy marker tape. Sterilized by ethylene oxide, the product has a validity period of 19 months and is disposable. The product is suitable for treating bile duct stricture caused by malignant tumor. (7) The Corporation Flexima Biliary Stent of the integrated biliary stent injected into the 20163462869 of the national equipment. The product is composed of a pre-installed stent and a conveyor. The stent was made of polyurethane and 40% barium sulfate, and the distal 1.5 cm fixed part was coated with Hydro-plus coating; the delivery device included a guide catheter and a push catheter. Ethylene oxide sterilization, single use. This product is used to implant a stent into the bile duct to drain the bile duct, to immobilize the bile duct during healing, or to keep the duct open in the presence of bile duct strictures or pasty stones. (8) The WallFlex Biliary RX Fully Covered Stent System RMV of the fully covered stent system for the 20163464497 of the bile duct injected by the National Equipment Company. The product consists of a pre-installed self-dilating metal stent for the bile duct and a push system. The stent is made of Nitinol and platinum and is molded into a cylindrical mesh structure covered with Permalume (dimethyl silicone) with a Nitinol recovery ring. There is an expansion port at each end of the stent to prevent it from moving after the stent is placed in the bile duct. The pushing system consists of a marking ring, an outer tube, an inner tube, a distal end handle, a proximal end handle, a mandrel and the like. Ethylene oxide sterilization, single use. Valid for 24 months. Bile duct covered stent system is suitable for palliative treatment of bile duct stricture caused by malignant tumors and benign bile duct stricture.
(9) Wallstent Endoscopic Biliary Endoprosthesis with Permalume Covering of metal stent for biliary tract covered with 20163465079 by Guoji. The product consists of implantable metal stent and UNISTEP. Plus push system composition. The stent is composed of biomedical superalloy monofilaments interwoven into a network of tubes and coated with silicone polymers (Permalume). Each end of the covered stent had an uncovered portion of about 5 mm in length. The pushing system is mainly composed of a coaxial tube, and the inner tube cavity of the coaxial tube can pass through a tube with the diameter of 0. 89mm （0. 035 "). Ethylene oxide sterilization, single use. The shelf life of the product is two years. The product is used for treating bile duct stricture caused by malignant tumor. (10) Percuflex Biliary Stent of plastic biliary stent injected with 20173461815 by Guoji Machinery Co., Ltd. This product is a plastic biliary stent, which can be packaged separately or packaged with a conveyor system. The biliary stent is made of EVA resin, bismuth subcarbonate, and white dye; the delivery device includes a push tube and a guide catheter. Ethylene oxide sterilization, disposable, valid for three years. The product is suitable for the treatment of biliary stricture. (11) Wallstent Biliary Endoscopic Biliary Endoprosthesis Uncovered of biliary metal stent with push system for injection 20173466397 of China National Machinery Co., Ltd. The product consists of stent and Unistep Plus push system. The stent is composed of a cobalt-based alloy, and the core wire is tantalum. The pusher system consists primarily of coaxial tubing with a 0.89 mm (0.035) guidewire through the lumen of the inner tube. The product can be inserted through the working channel of a therapeutic or diagnostic duodenoscope (minimum channel diameter 3.2 mm). Radiation sterilization, single use. Shelf life 2 years. The product is suitable for treating bile duct stricture caused by malignant tumor. (12) The Wallflex Biliary RX Uncovered Stent System of the non-membrane rapid exchange biliary tract metal stent system for 20173466228 injection of China Machinery Equipment Co., Ltd. The product is composed of stent and delivery system. The stent is made of metal wire with DFT process. The outer layer of the metal wire is nickel-titanium alloy. The inner core is platinum; the stent has a recovery ring that allows the stent to be removed during initial stent placement; and the stent has an expansion port at each end. The delivery system is a rapid exchange type consisting of an outer tube, an inner tube, a distal handle, a proximal handle, and a mandrel. Ethylene oxide sterilization, single use. Shelf life is 24 months. The product is used for palliative treatment of bile duct stricture caused by malignant tumor. (13) Transhepatic Biliary Tract Stent System Placehit Biliary Wallstent for 20173466830 Injected by National Instrument The product is composed of self-expanding stent and pushing system. The stent is braided with Elgiloy alloy wire and gold-plated tungsten wire; the push system can be inserted through the liver with either a 0.035- or 0.038-inch guidewire. Ethylene oxide sterilization, single use. The product is valid for 2 years. This product is used to maintain bile duct patency in patients with the following malignancies: a. Pancreatic cancer patients with tumor compression of the biliary system ；b. Patients with biliary tract obstruction caused by tumor ；c. Due to gallbladder cancer Patients with extrahepatic biliary obstruction caused by metastasis or ampullary carcinoma.
(14) The Wallflex Biliary RX Partially Covered Stent System of the partial membrane-covered rapid exchange biliary metal stent system injected into the 20193132211 by the National Machinery Company. The product consists of a stent and a delivery system. The stent is made of metal wires with DFT technology. The outer layer of the metal wire is made of nickel-titanium alloy, and the inner core is made of platinum; a part of the film is permalume (silicone resin); a recovery ring is arranged on the stent, so that the stent can be taken out during the first stent placement process; and an expansion port is arranged at each end of the stent. The delivery system is a rapid exchange type consisting of an outer tube, an inner tube, a distal handle, a proximal handle, and a mandrel. Ethylene oxide sterilization, single use. Shelf life 2 years. The product is used for palliative treatment of bile duct stricture caused by malignant tumor. 3奥林巴斯医疗株式会社オリンパスメディカルシステムズ株式会社 (1) Bile duct stent for injecting 20153130472 This product is composed of stent and auxiliary insertion instrument. Auxiliary insertion devices include pushers (push tubes, guide tubes), protective sleeves, and guide wires. The stent material is mainly composed of a high-density polyethylene low-density polyethylene mixture, a tetrafluoroethylene-hexafluoropropylene copolymer, polyamide, a tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer, stainless steel and the like, and the pusher is mainly composed of polytetrafluoroethylene, polyethylene and the like. The radiopaque substances are barium sulfate, bismuth oxide, and tungsten. The color of the bracket is yellow, green, blue and white. The product is sterilized by ethylene oxide. Biliary stent and pusher MAJ-1416/1417/1418/1419/1420/1421/1422 are disposable products, and other models/specifications can be reused. The shelf life of the disposable product is 3-5 years. The product is used in combination with the endoscope designated by the company. The biliary stent is placed in the bile duct through the endoscope to discharge bile. (2) The biliary stent for injecting 20183130497 into the biliary duct has pre-installed and non-pre-installed products. The preassembled product consists of a bracket, a pusher and a protective sleeve component. Non-preassembled products consist of brackets, protective sleeves or straighteners. There are also pusher models that are individually packaged. The scaffold is made of ethylene-vinyl acetate copolymer and bismuth oxide, and contains phthalocyanine blue dye. The product is sterilized by ethylene oxide and is disposable, and the sterilization period is 3 years. This product is to place a biliary stent in the bile duct through the endoscope to discharge bile. 4Sewoon Medical Co., Ltd. (1) Biliary Stent for 20163461394 Injection The stent is made of nickel-titanium alloy and consists of stent, radiopaque marker on the stent, radiopaque marker on the catheter, outer sheath, outer sheath tube, inner shaft, inner tube, olive-shaped tip, inner shaft handle, outer sheath handle and reduction device. The product is extinguished by ethylene oxide, is disposable and has a validity period of 3 years. The product is used for the treatment of biliary tract obstruction caused by malignant tumors and other reasons, which is inserted into the lesion site to help it become smooth. (2) Biliary Covered Stent of biliary tract covered stent injected into 20163462224 by Guoji Machinery Co., Ltd. The product consists of stent and transmission system. The stent is made of nickel-titanium alloy with platinum radiopaque markers and a polypropylene recovery noose, and is covered with a silicone rubber membrane. The delivery system consists of an outer sheath, an outer sheath tube, an inner shaft, an inner tube, an olive-shaped head end, a handle of the inner shaft, a handle of the outer sheath, a reset device and a visual marker. Sterilized by ethylene oxide, the product is disposable and valid for 3 years. The product is used for the treatment of biliary tract obstruction caused by malignant tumors and other reasons, which is inserted into the lesion site to help it become smooth.
5 S & G Biotech Inc. Of Aisji Biotechnology Co., Ltd. (1) The EGIS Biliary Stent of biliary stent injected into 20193132087 by Guoji Machinery Co., Ltd. consists of a single-layer bare stent and a delivery system. The stent consists of a component and a tracer. The component of the stent is made of nickel-titanium alloy material conforming to the requirements of GB24627 standard. The tracer is made of tungsten (gold-plated) material with a purity of 99.99%. The delivery system consists of a pusher, a sleeve, an olive end, a tracer, a catheter and a handle. The pusher is made of 304 L stainless steel and polypropylene material. The cannula is made of Teflon, 304 L stainless steel, nylon elastomer material and phthalocyanine blue, the olive end is made of polyvinyl chloride material, the tracer is made of tungsten and silicone material, the catheter is of polyetheretherketone material and the handle is of ABS material. Sterilized package, disposable. Shelf life is two years. The delivery system is used to insert the stent (self-expansion) into the lesion site to expand the biliary tract, treat biliary obstruction, and make the bile secretion of the obstruction site unobstructed. 6Angiomed GmbH＆Co.Medizintechnik KG (1) Biliary Stent for Injection of 20163462900 Biliary Stent consists of a delivery system and a stent. The stent was made of Nitinol, and there were four radiopaque tantalum markers at the proximal and distal ends of the stent. The delivery system is provided with platinum-iridium alloy radiopaque markers and consists of an outer catheter, an inner catheter, a catheter tip, a Luer connector, a safety clip wing, a safety clip, a handle, a conversion wing, a trigger, a pullback device and a guide rod. The product is sterilized by ethylene oxide and is disposable. The product is valid for 3 years. The product is suitable for treating biliary stricture caused by malignant tumor. 7 Wilson-Cook Medical Incorporated (1) Metal Biliary Stent System for 20173465088 Injection Zilver Expandable Metal Biliary Stent System Metal Biliary Stent System consists of stent and delivery system. The stand is made of Nitinol and has four 24-karat gold markers on each end; the delivery system consists of a head end A sheath tube, a pusher, a handle and a metal sleeve. Ethylene oxide sterilization, valid for 3 years, disposable. Metallic biliary stent systems are used to relieve symptoms of malignant biliary tract tumors. 8 Korea Maytag M. I. Tech Co., Ltd. (1) Biliary stent HANAROSTENT Biliary Stent for injection 20183461814 of national equipment The product consists of a pre-assembled stent and a pusher. The pusher includes a push rod and an outer sheath. The stent is woven into a cylindrical shape by nickel-titanium alloy wires. Ethylene oxide sterilization, single use. The sterile validity period of the product is 3 years. The product is used for dilating biliary stricture caused by benign and malignant tumors. 9Taewoong Medical Co.,Ltd. (1) National Instrument Injection 20163462793 Biliary Tract Uncovered Stent Niti-S Biliary Uncovered Stent This product consists of a handle, a Y-shaped connector, a pusher, an outer sheath, an intermediate catheter, a radiation-detectable marker, a yellow marker, a bindings, an inner catheter, a tip and a stent. The stent was made of nickel-titanium alloy, and the radiolabeling materials were 316 L stainless steel and platinum-iridium alloy. The delivery system is divided into endoscopic delivery system and percutaneous delivery system, which is made of ABS, 304 stainless steel, PTFE, PEBAX, platinum-iridium alloy, nylon, polyolefin, polyetheretherketone, tungsten and other materials. The stent is divided into S-type stent and D-type stent according to different weaving methods. Ethylene oxide sterilization, disposable product. Valid for 3 years. The product is mainly used for biliary stricture caused by primary and/or secondary malignant/benign tumors to help restore the smooth of the stricture.
(2) Niti-S Biliary Covered Stent, a 20163462808 biliary covered stent, is composed of a stent and a delivery system. The braiding type of the stent is S-type, the main body material is nickel-titanium alloy, the ray detectability marker material is 316L stainless steel and platinum-iridium alloy, the coating material is silicone, and the stent is provided with nylon material strings. The delivery system is divided into an endoscope delivery system and a percutaneous delivery system and consists of a handle, a Y-shaped connector, a pusher, an outer sheath, an intermediate catheter, a ray detectable marker, a yellow marker,Titanium welding pipe, an bindings, an inner catheter and a tip. Ethylene oxide sterilization, disposable product. The product is mainly used for biliary stricture caused by primary and/or secondary malignant/benign tumors to help restore the smooth of the stricture. END Return to Sohu to see more Responsible Editor:. yunchtitanium.com