Cook Medical Peripheral Intervention MRI Information

Transcription

1 Page 1 of 13 Home My Account Help Careers Text size: A A A Home / Clinical / Peripheral Intervention / Products / I Information Browse by Product Family Disease State Alphabetical Cook Medical adheres to the F standard of (magnetic resonance) terminology adopted by the American Society for Testing and Materials (ASTM). This practice of marking medical devices came about in an effort to clarify the terminology, provide a uniform system for marking and, more important, because misuse of old terminology could result in serious injuries for patients and other individuals. This new system references the environment where testing took place, which includes field strength, spatial gradients, db/dt (time rate of change of the magnetic field), radio frequency (RF) fields and specific absorption rate (SAR). I Information Taking these conditions into consideration, three new categories of marking exist: Safe, Conditional, and Unsafe. In this system, safe and unsafe are the two extremes. Conditional is in the middle and characterizes the behavior of a medical device under specific conditions in the environment as determined by testing. In addition to the new terms, the ASTM International document introduced corresponding icons consistent with international standards for colors and shapes of safety signs. The icons are intended for use on items that may be brought into or near the environment as well as in product labeling. The new terminology and icon structure is intended to help clarify matters related to biomedical implants and devices to ensure the safe use of I technology. Safe An item that poses no known hazards in all environments. Safe items include nonconducting, nonmetallic, nonmagnetic items such as plastic, silicone and glass. An item may be determined to be Safe on the basis of scientific rationale rather than test data. Conditional An item that has been demonstrated to pose no known hazards in a specified environment with specified conditions of use. Field conditions should be enumerated on the product, its packaging or in the enclosed literature. Additional conditions, including specific configurations of the item, may be required. Unsafe An item that is known to pose hazards in all environments. Unsafe items include magnetic items such as a pair of ferromagnetic scissors.

2 Page 2 of 13 Products Embolization Coils Nester MicroNester Microcoils Tornado Hilal Microcoils eye eye Flipper Stents Zilver 518 R Zilver 518 Zilver 518 Biliary Zilver 635 Zilver 635 Biliary Zilver Flex 35 Biliary Formula 418 Material Order Number (Prefix) NOT AVAILABLE NESTER NESTER TORNADO Safe Conditional HILAL Inconel IMWCE Inconel IFMWCE Nitinol ZIV5 Nitinol ZIV5 Nitinol ZIB5 Nitinol ZIV6 Nitinol ZIB6 Nitinol ZIB6-35 FORB4 Unsafe

3 Page 3 of 13 Vena Cava Filters Günther Tulip Cook Celect Gianturco- Roehm Bird's Nest Conichrome IGTCFS Conichrome IGTCFS- CELECT BNF Conichrome is a trademark of Carpenter Technologies. Inconel is a registered trademark of Huntington Alloys Corporation. Cook Celect Vena Cava Filter Nonclinical testing has demonstrated that the Cook Celect Vena Cava Filter is Conditional according to ASTM F2503. A patient with a Cook Celect Vena Cava Filter can be scanned safely under the following conditions: Static magnetic field of 1.5 tesla or 3.0 tesla Maximum spatial magnetic gradient of 1,600 gauss/cm (16.0 T/m) or less Normal operating mode Maximum system-reported, whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of scanning or less (i.e., per scanning sequence) 1.5 Tesla Temperature Rise In nonclinical testing, the Cook Celect Vena Cava Filter produced a maximum temperature change of 3.7 C during 15 minutes of I (i.e., for one scanning sequence) performed in a 1.5 tesla system (1.5 tesla/64 MHz, Siemens Magnetom Avanto, Numaris/4 syngo B17) at an system-reported whole-body-averaged SAR of 2.05 W/kg (associated with a calorimetry-measured whole-body-averaged value of 1.75 W/kg). 3.0 Tesla Temperature Rise In nonclinical testing, the Cook Celect Vena Cava Filter produced a maximum temperature change of 4.2 C during 15 minutes of I (i.e., for one scanning sequence) performed in a 3.0 tesla system (3.0 tesla/128 MHz, Siemens Magnetom Trio, A Tim System,

4 Page 11 of 13 Nester Embolization Coils Non-clinical testing has demonstrated that the Nester Embolization Coil is Conditional according to ASTM F2503. A patient with this coil can be scanned safely anytime after placement under the following conditions. Static magnetic field of 3.0 Tesla or less Maximum spatial magnetic gradient of 1600 Gauss/cm or less Maximum system reported, whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning or less (i.e., per scanning sequence) In non-clinical testing, the Nester Embolization Coil produced a maximum temperature rise of 1.6 C during 15 minutes of imaging (i.e., for one scanning sequence) performed in a 3 Tesla System (General Electric Healthcare Excite, HDx, Software 14.M5) at an system reported whole body averaged SAR of 2.9 W/kg (associated with a calorimetry measured whole body averaged value of 2.7 W/kg). Image Artifacts image quality may be compromised if the area of interest is within approximately 9 mm of the position of the Nester Embolization Coil, as found during non-clinical testing using the sequence: T1-weighted, spin echo and gradient echo pulse sequence in a 3.0 Tesla system (General Electric Healthcare Excite, HDx). Therefore, it may be necessary to optimize imaging parameters for the presence of this metallic embolization coil. For US Patients Only Cook recommends that the patient register the conditions disclosed in this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be contacted in the following manners: Mail: MedicAlert Foundation International 2323 Colorado Avenue Turlock, CA Phone: (toll free) from outside the US Fax: Web: Tornado Embolization Coils Non-clinical testing has demonstrated that the Tornado Embolization Coil is Conditional according to ASTM F2503. A patient with this coil can be scanned safely anytime after placement under the following conditions.

5 Page 12 of 13 Static magnetic field of 3.0 Tesla or less Maximum spatial magnetic gradient of 1600 Gauss/cm or less Maximum system reported, whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning or less (i.e., per scanning sequence) In non-clinical testing, the embolization coil produced a maximum temperature rise of 1.6 C during 15 minutes of imaging (i.e., for one scanning sequence) performed in a 3 Tesla System (General Electric Healthcare Excite, HDx, Software 14.M5) at an system reported whole body averaged SAR of 2.9 W/kg (associated with a calorimetry measured whole body averaged value of 2.7 W/kg). Image Artifacts image quality may be compromised if the area of interest is within approximately 9 mm of the position of the Tornado Embolization Coil, as found during non-clinical testing using the sequence: T1-weighted, spin echo and gradient echo pulse sequence in a 3.0 Tesla system (General Electric Healthcare Excite, HDx). Therefore, it may be necessary to optimize imaging parameters for the presence of this metallic embolization coil. For US Patients Only Cook recommends that the patient register the conditions disclosed in this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be contacted in the following manners: Mail: MedicAlert Foundation International 2323 Colorado Avenue Turlock, CA Phone: (toll free) from outside the US Fax: Web: Zilver Self-Expanding Stent Nonclinical testing has demonstrated that the Zilver Self-Expanding Stent is Conditional. It can be scanned safely under the following conditions: Static magnetic field of 3 tesla or less Spatial gradient field of 720 gauss/cm or less Whole-body averaged specific absorption rate (SAR) of 1.5 W/kg (for a single stent at 1.5 tesla) and 3 W/kg (for a single stent at 3 tesla and a pair of overlapping stents at 1.5 and 3 tesla) for 20 minutes