COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The subject devices, the Nester and Tornado Embolization Coils, and the predicate device, the Retracta Detachable Embolization Coil (K123712/151676), are substantially equivalent in that Module 2: MRI in patients with cerebral aneurysm clip. This product line is serviced by the following clinical division (s): Aortic Intervention . G47349: Cook Nester Embolization Coil 0.035" x 14cm x 18mm. PDF View Specifications Videos Documents Images. Nester Embolization Coil G26992 / MWCE-35-14-12-NESTER. Extended Embolus Length: 7cm. 4 Nester EMBOLIZATION COIL Platinum coil with synthetic fibers used for arterial and venous embolization. Interventional Radiology . A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. A patient can be safely scanned immediately after placement of the coils, under the following conditions: Static magnetic field of 1.5 and 3.0 Tesla. Safety Topic / Subject Coils, Filters, Stents, and Grafts. Categories Cook G23523 Nester Embolization Coil .035", 7cm x 3mm. These coils are prescription devices implanted by G52732 NESTER PLATINUM EMBOLIZATION MICROCOIL MWCE-18-3-3-NESTER. Embolization Coil MWCE-38-14-12 NESTER Platinum, Inconel coils, filters, stents Cook Medical, www.cookmedical.com Device Characteristics. Used for arterial and venous vessel embolisation. Cook G23523 Nester Embolization Coil .035", 7cm x 3mm Safety; Sterilization. Straight Hilal Embolization Microcoil. Multi-Curled Hilal Embolization Microcoil. PDF View The coils are available in lengths from 3 to 20 cm, and in diameters from 2 to 20 mm when coiled. MRI SAFETY INFORMATION Nonclinical testing has demonstrated that single and multiple Nester Embolization Coils and Microcoils are MR Conditional according to ASTM F2503. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an Society for Medical Physics of the Netherlands (NVKF). Manufacturer: Cook Inc. G23523 MWCE-35-7-3-NESTER 3cm NESTER PLATINUM EMBOLIZATION MICROCOIL, 7cm Extended Embolus Length, 3mm Coiled Embolus Diameter. $299.00. Specifications Videos Documents Images. Non-neurovascular embolization coil. Since 1963, Cook has been a leader in developing health care devices that have improved lives around the world. Straight Hilal Embolization Microcoil. Single-Curled Hilal Embolization Microcoil. Case reviews. Slesnick TC, Schreier J, Soriano BD, et al. Translations in context of "LIPIODOL" in portuguese-english. Decrease Quantity of Embolization Coil - MWCE-35-5-10 - 10mm x .035" x 5cm Increase Quantity of Embolization Coil - MWCE-35-5-10 - 10mm x .035" x 5cm. Approximate Number of Loops: 3.7. Specifications Videos Documents Images. Nester Embolization Coil. ever, a secondary effect has been limitations on magnetic resonance imaging (MRI) for these patients. Object Status Conditional 5. Cook Medical. It is widely known that these embolization coils can create signicant susceptibility image artifacts when patients undergo MRI [9]. The coils are available in lengths from 3 to 20 cm, and in diameters from 2 to 20 mm when coiled. HERE are many translated example sentences containing "LIPIODOL" - english-portuguese Embolization coil lawsuits against the drugmaker, Cook, Inc., are the most effective means for consumers to recover compensation and hold the company accountable for the harm defective Cook embolization coils have caused in Indiana. Sign in to add this product to your favorites! COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The subject devices, the Nester and Tornado Embolization Coils, and the predicate device, the Retracta Detachable Embolization Coil (K123712/151676), are substantially equivalent in that 4 Nester EMBOLIZATION COIL Platinum coil with synthetic fibers used for arterial and venous embolization. Multi-Curled Hilal Embolization Microcoil. Pediatric Cardiol 2016; 37:62-67. Cook. A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. Device Characteristics. In 2011, Cook designated these coils as MRI-unsafe due to their ferromagnetic properties but after further testing by the manufacturer, the coils were designated as MR-conditional in 2012. Soft coil conforms within vessel for tight occluding mass. Concerto Helix and 3D Detachable Coil Systems. Recommended Catheter ID and End Hole Diameter: 0.035". Recently, the safety of these coils in a magnetic resonance environment has been called into question, with important ramifications for thousands of patients with existing coils in place. We perfor Stainless steel embolization coils (SSEC) have been used for over four decades for vascular occlusion. Translations in context of "LIPIODOL" in english-portuguese. Coils synthetic fibers help promote clot formation. SKU: G52732 Weight: 3.00 LBS Availability: ships in 2-3 business days Safety; Sterilization. $10.00. Object Status Conditional 5. Used for arterial and venous embolisation. Non-clinical testing and analysis have demonstrated that when used in peripheral vasculature Stryker Detachable Coils are MR Conditional. Nester Embolisation Coil. Nester coils are suitable for use as starting, packing, and finishing coils Fully fibered for thrombogenicity The synthetic fibers promote clot formation Easily visible under fluoroscopy MR conditionally safe at 3T and 1.5T Can be used in combination with other pushable and detachable embolization coils Nester coils are designed to provide value for: Nester conforms inside the vessel to create a tight occluding mass. More on Cook. Translations in context of "LIPIODOL" in english-portuguese. G47349: Cook Nester Embolization Coil 0.035" x 14cm x 18mmIn-Date Cook Embolization. Safety of magnetic resonance imaging after implantation of stainless steel embolization coils. Object Category Coils, Filters, Stents, and Grafts. Used for arterial and venous embolisation. Cook Incorporated Traditional 510(k) 2 Nester and Tornado Embolization Coils March 30, 2016 VI. Nester coils are intended for arterial and venous embolization. The .035" Nester Embolization Coil and the .038" MReye Embolization Coil are possible replacement options. This product is not for sale in Germany. Moreover, with MRI there are potential safety con-cerns including localized temperature elevation, induction Photos are for illustration purposes only and may not depict the exact item. Single-Curled Hilal Embolization Microcoil. Strength 3.0. 5,6,8,13,14 Prior to the 1996 introduction of MR-conditional embolization coils (Mreye , William Cook, Europe), embolization was performed using steel coils that were not designated as being Nester Embolization Coils (0.035 and 0.038) and 0.018 Microcoils are made of platinum with spaced synthetic fibers, and are supplied preloaded in a loading cartridge. Nester Embolization Coils are intended for arterial and venous embolization in the peripheral vasculature. Product design Nester Embolization Coils are made of platinum with spaced synthetic fibers and are supplied preloaded in a loading cartridge. Scan (MRI). Recently, the safety of these coils in a magnetic resonance environment has been called into question, with important ramifications for thousands of patients with existing coils in place. What MRI safety information does the labeling contain? Neurovascular embolization coils are used in the treatment of brain aneurysms and other vascular abnormalities. HERE are many translated example sentences containing "LIPIODOL" - english-portuguese ever, a secondary effect has been limitations on magnetic resonance imaging (MRI) for these patients. Cook. The coil has a large number of profiles to use in the .018 Inch and .035 Inch systems The coils are available in lengths of 2.6 to 12.5 cm The coils are available in a range of diameters that taper from 3 to 2 mm for small coils and 10 to 5 mm for larger coils Embolization was performed at Hammersmith Hospital (now part of Imperial College Healthcare NHS Trust), according to clinical need, as reported elsewhere. Recommended Catheter ID and End Hole Diameter: 0.035" Extended Embolus Length: 14cm; Coiled Embolus Diameter: 12mm; Approximate Number of Loops: 3.7; More on Cook. Description. Learn more about the Concerto Helix and 3D detachable coil systems. Spatial gradient field up to 2500 Gauss/cm (25 Tesla/m) This product line is serviced by the following clinical division (s): Interventional Radiology . The embolization system is composed of three unique coil technologies: the Ruby Coil, POD (Penumbra Occlusion Device), and POD Packing Coilall of which are large-volume coils that are similar in caliber to a 035 coil and are deliverable through LANTERN, a high-flow microcatheter ( Figure 1 ). Soft platinum Nester coils are available in 0.018" and 0.035" sizes. For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact Boston Scientific Customer Service. Stainless steel embolization coils (SSEC) have been used for over four decades for vascular occlusion. Most neurovascular embolization coils currently on the market are labeled as Magnetic Resonance (MR) Conditional. Translations in context of "LIPIODOL" in portuguese-english. This product is not for sale in Germany. The Concerto Helix and 3D detachable coil systems consist of both helical and framing options for mechanical embolization of peripheral vasculature. $225.00. It is widely known that these embolization coils can create signicant susceptibility image artifacts when patients undergo MRI [9]. What MRI safety information does the labeling contain? The MR Conditional information in the product labeling conveys to Soft coil conforms within vessel for tight occluding mass. Strength 3.0. Device Description: Nester Embolization Coil CLOSE. Coiled Embolus Diameter: 6mm. Platinum coil provides enhanced radiopacity and allows the coil to be MR conditional up to 3 T. Embolization Coil MWCE-38-14-12 NESTER Platinum, Inconel coils, filters, stents Cook Medical, www.cookmedical.com This product line is serviced by the following clinical division (s): Interventional Radiology . MR conditionally safe at 3T and 1.5T Can be used in combination with other pushable and detachable embolization coils Nester coils are designed to provide value for: It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an Safety Topic / Subject Coils, Filters, Stents, and Grafts. HERE are many translated example sentences containing "LIPIODOL" - portuguese-english translations and search engine for portuguese translations. Since 1963, Cook has been a leader in developing health care devices that have improved lives around the world. For Healthcare Professionals. Note: Safety information provided is for the United States. Adding to cart The item has been added Nester Embolization Coil MWCE-35-7-10-NESTER - .035" x 7cm x 10mm. Soft platinum Nester coils are available in 0.018" and 0.035" sizes. Moreover, with MRI there are potential safety con-cerns including localized temperature elevation, induction Categories Categories Brands Brands Cook G52732 Nester Embolization Coil .018, 3cm x 3mm. Cook Incorporated Traditional 510(k) 2 Nester and Tornado Embolization Coils March 30, 2016 VI. HERE are many translated example sentences containing "LIPIODOL" - portuguese-english translations and search engine for portuguese translations. Sterilization Supplies; Techna-Cut Biopsy Needles; Veterinary Otoscopes; Price: $65.00 EACH. If using a .018 inch Nester Embolization Microcoil, ensure that the delivery catheter has an internal diameter (ID) of .018 to .025 inch. PRODUCT RECOMMENDATIONS The following table offers specific recommendations. Guideline use of MRI in patients with implants. Ideally suited for occlusion of most vessels. Specifications Videos Documents Images. Platinum coil provides enhanced radiopacity and allows the coil to be MR conditional up to 3 T. Nester Embolization Coil. Stainless steel embolization coils (SSEC) have been used for over four decades for vascular occlusion. Used for arterial The coils are available in lengths from 3 to 20 cm, and in diameters from 2 to 20 mm when Object Category Coils, Filters, Stents, and Grafts. Device Description: Nester Embolization Coil CLOSE. Recently, the safety of these coils in a magnetic resonance environment has been called into question, with important ramifications for thousands of Coils synthetic fibers help promote clot formation. Ideally suited for occlusion of most vessels. Nester conforms inside the vessel to create a tight occluding mass. Access our instructions for use and product manuals library. G52743 / MWCE-35-7-6-NESTER. Non-neurovascular embolization coil. They are designed to be delivered to the target vessel using MRI SAFETY INFORMATION Nonclinical testing has demonstrated that single and multiple Nester Abstract. 11 Aug 2018 Safety of Magnetic Resonance Imaging After Implantation of Stainless Steel Stainless steel embolization coils (SSEC) have been used for over four Inc. of their standard embolization coils from a designation of magnetic Varicocele embolization uses imaging guidance and a catheter to place a tiny coil and/or embolic fluid in a blood vessel to Nester coils are intended for arterial and venous embolization.