Product Availability

Every effort is made by Cook Medical to ensure each item listed in the catalog is maintained in stock. Due to the breadth of items listed and the dynamic nature of the product line, Cook does not guarantee all items listed are in stock. If you have any questions, please contact us.

Product Warranty

We warrant that, at the time of manufacture, products were prepared and tested in accordance with quality system regulations specified by the regulatory bodies in the countries Cook serves and were true to label.

Because of biological differences in individuals, no product is 100% effective under all circumstances. In addition, because we have no control over the condition under which the product is used, diagnosis of the patient, the method of use or administration and handling of the product after it leaves our possession, we do not warrant either a good effect or against an ill effect following the product’s use. The foregoing warranty is exclusive and in lieu of all other warranties either written, oral or implied (including any warranties of merchantability or fitness for purpose). No representative of the company may change any of the foregoing, and the buyer accepts the product subject to all terms hereof.

Design Changes

Cook reserves the right to change or discontinue any product without notice. Additionally, if the product has been discontinued, we can recommend alternatives.

Product Expiration

Most Cook products have an expiration date on the label. This date is based on concerns for product integrity and sterility maintenance. An unlimited shelf life cannot be verified by testing; therefore, some limit must be placed on the life of products. Cook attempts to maximize the shelf life of our products through testing; however, storage conditions of our customers may affect the length of this period.

Product Storage

Cook products should be stored in a dark, cool and dry place. Extended periods of exposure to light have resulted in degradation of some plastic materials and should be avoided. Extended periods of elevated temperature can reduce the shelf life of a product and should also be avoided.

Sterilization of Reusable Products

It is the responsibility of the institution that is operating sterilization equipment to validate the equipment. In order to sterilize a reusable product using an autoclave, it must first be properly cleaned and/or disinfected, and then packaged using AAMI recommended practices. During product handling, attention should be given to coil products in an 8 inch diameter or greater. Do not put the original product packaging through an autoclave cycle; it will not withstand the sterilization temperature. Some products must not be autoclaved. Refer to product instruction or contact customer service for specific parameters regarding autoclave sterilization methods.

Autoclave chamber loading should not exceed 10 products per cubic foot of chamber space or exceed the usable chamber space. If any damage to a product is noted, it should be taken out of service immediately.

• Cleaning & Sterilization

  Cook manufactures sterile and nonsterile medical devices.

  Cook's in-house sterilization facility uses an environmentally friendly mixture of ethylene oxide (ETO) as a sterilant. ETO is used because of its compatibility with a wide variety of manufacturing materials, including Tyvek® sealed packaging.

  Over the years, Tyvek has proven to be an excellent microbial barrier in maintaining product sterility over shelf life, as long as the package seal is intact and not exposed to hostile environmental storage conditions, including temperatures above 104°F (40°C), a relative humidity above 90% and condensing humidity.

  Cook's use of Tyvek sealed packages in our validated industrial sterilization process allows for the efficient processing of the quality products you have come to depend upon. As with most industrial sterilization processes, the sterilization parameters used cannot be duplicated by most institution sterilizers. It is for this reason that we have developed and tested sterilization cycles based on AAMI-recommended practices to achieve a sterility level of 10^-6.

  If AAMI Standards and Recommended Practices for sterilization are not available at your institution, you can contact AAMI at 703-525-4890 or 800-332-2264, ext. 217.

  Validation is a documented procedure for obtaining, recording and interpreting the results needed to show that a process will consistently yield a product complying with predetermined specifications.

  Tyvek® is a registered trademark of E.I. DuPont de Nemours & Co.

   

• Sterilization of Disposable and Reusable Products Using Ethylene Oxide

  It is the responsibility of the institution that is operating sterilization equipment to validate that equipment. In order to sterilize a reusable Cook product using ETO, it must first be properly cleaned and/or disinfected according to product instructions and then packaged using AAMI recommended practices. During product handling, attention should be given to coil products 8 inches in diameter or greater. Disposable products either accidentally opened and not used and/or ordered nonsterile may be sterilized one time only. Some products must not be ETO sterilized. Refer to product instructions or contact customer service for the proper sterilization method. Table 1 shows the recommended ETO sterilization cycle parameters:

  TABLE I - ETO CYCLE PARAMETERS
  PARAMETER	SET POINT
  Pre-Vacuum Pressure	2.0 psia (-25.9" Hg Vac)
  Relative Humidity	60% RH
  Humidity Dwell	20 minutes
  Chamber Temperature	54.4°C (130°F)
  Exposure Pressure	To Be Determined (1)
  Exposure Dwell	2 hours
  ETO Concentration	600 mg/L
  Post-Vacuums	3
  Post-Vacuum Pressure	2.0 psia (-25.9" Hg Vac)
  Air Wash (2)	5 minutes
  Aeration Temperature	54.4°C (130°F)
  Aeration Dwell	12 hours
  Air Changes During Aeration	90 per hour

  ETO sterilizer chamber loading should not exceed 11 products per cubic foot of chamber space or exceed the usable chamber space. If any damage to a product is noted prior to sterilizing, it should be taken out of service immediately.

• Sterilization of Reusable Products Using An Autoclave

  It is the responsibility of the institution that is operating sterilization equipment to validate that equipment. In order to sterilize a reusable Cook product using an autoclave, it must first be properly cleaned and/or disinfected according the product instructions and then packaged using AAMI recommended practices. During product handling, attention should be given to coil products in an 8 inch diameter or greater. Do not place the original product packaging in an autoclave; it will not withstand the sterilization temperature. Some products must not be autoclaved. Refer to product instructions or contact customer service for the proper sterilization method. Table II shows the recommended autoclave cycle parameters for Cook reusable products.

  TABLE II - AUTOCLAVE CYCLE PARAMETERS
  PARAMETER	SET POINT
  Cycle Type	Pre-Vacuum
  Pre-Vacuum Pressure	2.5 psia (-24.8" Hg Vac)
  Chamber Exposure Temperature	132.2°C (270°F)
  Chamber Exposure Pressure	41.8 psia (27.1 psig)
  Exposure Dwell	5 minutes

  Autoclave chamber loading should not exceed 10 products per cubic foot of chamber space or exceed the usable chamber space. If any damage to a product is noted prior to sterilizing, it should be taken out of service immediately.

• Questions & Answers

  A number of questions are frequently asked by customers concerning the sterilization or resterilization of Cook products. Some of these questions are answered below.

  Disposable Products

  Question: Under what conditions should a sterile product labeled “disposable - intended for one-time use” or “disposable - single use only” not be sterilized?

  Answer: Cook does not recommend the sterilization of “disposable - intended for one-time use” or “disposable - single use only” products that have been used, stored beyond labeled expiration date or subjected to hostile environmental storage conditions, including temperatures above 104°F (40°C), a relative humidity above 90% and condensing humidity.

  Question: If a sterile product labeled as “disposable - intended for one-time use” or “disposable - single use only” is accidentally opened and then not used, can it be sterilized?

  Answer: Yes, the product can be sterilized using a validated ethylene oxide sterilization cycle. However, the product must be repackaged using AAMI recommended practices prior to sterilization.

  Question: Can “disposable - intended for one-time use” or “disposable - single use only” product ordered as nonsterile be sterilized?

  Answer: Yes, the product can be sterilized using a validated ethylene oxide sterilization cycle if the product is supplied in a Tyvek pouch or Tyvek sealed tray. Otherwise, it must be repackaged using AAMI recommended practices prior to sterilization.

  Question: Can Cook advise me of the ethylene oxide sterilization cycle to use on one of its “disposable - intended for one-time use” or “disposable - single use only” products either accidentally opened and not used and/or ordered nonsterile?

  Answer: Yes. The cycle parameters for sterilizing disposable products are shown in Table 1 of the ethylene oxide sterilization section of Cleaning and Sterilization and may be used one time only.

  Reusable Products

  Question: Can the original package in which Cook provides its reusable products be ETO sterilized?

  Answer: Product provided in a Tyvek pouch or a Tyvek sealed tray may be ETO sterilized. Other Cook packaging configurations must be repackaged using AAMI recommended practices prior to sterilization.

  Question: Can the original package in which Cook provides its reusable products be placed in an autoclave?

  Answer: No, original Cook packaging materials for reusable products cannot withstand autoclave cycle parameters.

  Question: Can Cook advise me of the proper ethylene oxide sterilization cycle to use on its reusable products?

  Answer: Yes, Cook has validated an ethylene oxide sterilization cycle that can be used in an institutional setting. However, the product must be properly cleaned and/or disinfected according to product instructions and then packaged using AAMI recommended practices (AAMI, ST41) prior to sterilization.

  Question: Can Cook advise me of the autoclave cycle to use for its reusable products?

  Answer: Yes. Cook has validated an autoclave cycle that can be used in an institutional setting. However, the product must be properly cleaned and/or disinfected according to product instructions and then packaged using AAMI recommended practices (AAMI, SSSA) prior to sterilization.

  Question: Can Cook reusable products be disinfected by means of cold disinfectants?

  Answer: Yes. Cook reusable products can be disinfected using cold disinfectants. Refer to cold disinfectant manufacturer's instructions for recommended use.

Product Labels

MRI Information

• Zenith Flex® AAA Endovascular Graft

  
    (excerpted from IFU)

  MRI Information
  Non-clinical testing has demonstrated that the Zenith AAA Endovascular Graft is MR Conditional. A patient with this endovascular graft can be scanned safely immediately after placement under the following conditions:

  Static Magnetic Field

  • Static magnetic field of 3.0 Tesla or less.
  • Highest spatial magnetic gradient field of 720 gauss/cm

  Non-clinical evaluation was conducted in a 3 Tesla MR system (General Electric Excite) with a maximum spatial magnetic gradient field of 720 gauss/cm as measured with a gaussmeter in the position of the static magnetic field pertinent to the patient (i.e., outside of scanner covering, accessible to a patient or individual).

  MRI-Related Heating

  1.5 Tesla Systems:

  • Static magnetic field of 1.5 Tesla
  • Maximum whole-body-averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning (i.e., per scanning sequence)

  In non-clinical testing, the Zenith AAA Endovascular Graft produced a temperature rise of less than or equal to 1.4°C at a MR system reported whole-body-averaged specific absorption rate (SAR) of 2.8 W/kg for 15 minutes of MR scanning in a 1.5 Tesla Magnetom, Siemens Medical Magnetom, Numaris/4 Software, Version Syngo MR 2002B DHHS MR Scanner. The maximum whole-body-averaged specific absorption rate (SAR) was 2.8 W/kg, which corresponds to a calorimetry measured value of 1.5 W/kg.

  3.0 Tesla Systems:

  • Static magnetic field of 3.0 Tesla
  • Maximum whole-body-averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning (i.e., per scanning sequence)

  In non-clinical testing, the Zenith AAA Endovascular Graft produced a temperature rise of less than or equal to 1.9°C at a MR system reported whole-body-averaged specific absorption rate (SAR) of 3.0 W/kg for 15 minutes of MR scanning in a 3.0 Tesla Excite, GE Electric Healthcare, G3.0-052B Software, MR Scanner. The maximum whole-body-averaged specific absorption rate (SAR) was 3.0 W/kg, which corresponds to a calorimetry measured value of 2.8 W/kg.

  Image Artifact

  The image artifact extends throughout the anatomical region containing the device, obscuring the view of immediately adjacent anatomical structures within approximately 20 cm of the device, as well as the entire device and its lumen, when scanned in nonclinical testing using the sequence: Fast spin echo, in a 3.0 Tesla, Excite, GE Electric Healthcare, with G3.0-052B Software, MR system with body radiofrequency coil.

  For all scanners, the image artifact dissipates as the distance from the device to the area of interest increases. MR scans of the head and neck and lower extremities may be obtained without image artifact. Image artifact may be present in scans of the abdominal region and upper extremities, depending on distance from the device to the area of interest.

  Clinical information is available for seventeen patients who received MRI scans after stent-graft implantation. There have been no reported adverse events or device problems in any of these patients as a result of having received an MRI. Additionally, there have been well over 100,000 Zenith AAA Endovascular Grafts implanted worldwide, in which there have been no reported adverse events or device problems as a result of MRI.

  Cook recommends that the patient register the MR 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 95382
  Phone:	888.633.4298 (toll free) 209.668.3333 from outside the U.S.
  Fax:	209.669.2450
  Web:	www.medicalert.org

• Cook Celect™ Vena Cava Filter

  Nonclinical testing has demonstrated that the Cook Celect Vena Cava Filter is MR Conditional. It can be scanned safely immediately after placement under the following conditions:

  • Static magnetic field strengths of 3.0 tesla or less
  • Maximum spatial gradient field of 330 gauss/cm or less
  • Maximum whole-body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of scanning

  In nonclinical testing, the Cook Celect Vena Cava Filter produced a temperature rise of less than 0.2°C at a maximum whole-body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MR scanning in a 3.0 tesla MR system using a transmit/receive body coil MR scanner. MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the Cook Celect Vena Cava Filter. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic implant.

• Cook Medical adheres to the F2503-08 standard of MR (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 MR 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).

  Taking these conditions into consideration, three new categories of MR marking exist: MR Safe, MR Conditional, and MR 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 MR 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 MR 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 MRI technology.

  	MR Safe—An item that poses no known hazards in all MR environments. MR Safe items include nonconducting, nonmetallic, nonmagnetic items such as plastic, silicone and glass. An item may be determined to be MR Safe on the basis of scientific rationale rather than test data.
  	MR Conditional—An item that has been demonstrated to pose no known hazards in a specified MR 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.
  	MR Unsafe—An item that is known to pose hazards in all MR environments. MR Unsafe items include magnetic items such as a pair of ferromagnetic scissors.

   

  Products	Material	Order Number (Prefix)	MR Safe	MR Conditional	MR Unsafe
  AAA Endovascular Graft
  Zenith Flex®         Visit product page »	Stainless Steel	TFFB, TFB, TFLE, ESBE, ESC, ESLE, ZIP, ESP		X
  Zenith Renu®         Visit product page »	Stainless Steel	AX1, RX1		X
  Biopsy Needle
  Chiba Biopsy Needles         Visit product page »	Inconel®	IDCHN		X
  Embolization Coils
  Stainless Steel	Stainless Steel	NOT AVAILABLE		X
  Nester®         Visit product page »	Platinum	MWCE-NESTER		X
  MicroNester®      Microcoils™         Visit product page »	Platinum	MWCE-NESTER		X
  Tornado®         Visit product page »	Platinum	MWCE-TORNADO		X
  Hilal Microcoils™         Visit product page »	Platinum	MWCE-HILAL		X
  MReye®         Visit product page »	Inconel	IMWCE		X
  MReye Flipper®         Visit product page »	Inconel	IFMWCE		X
  Reconstructive Surgery (Doppler Monitoring)
  Cook-Swartz Doppler      Flow Probe         Visit product page »	Misc. Materials	DP			X
  Stents
  Zilver 518® RX Vascular         Visit product page »	Nitinol	ZIVX5		X
  Zilver 518® Vascular         Visit product page »	Nitinol	ZIV5		X
  Zilver 518® Biliary         Visit product page »	Nitinol	ZIB5		X
  Zilver 635® Vascular         Visit product page »	Nitinol	ZIV6		X
  Zilver 635® Biliary         Visit product page »	Nitinol	ZIB6		X
  Zilver Flex™ 35 Biliary         Visit product page »	Nitinol	ZIB6-35		X
  Formula™ 418         Visit product page »	Stainless Steel	FORB4		X
  TAA Endovascular Graft
  Zenith® TX2®         Visit product page »	Stainless Steel	ZTEG, ESBE		X
  Vena Cava Filters
  Günther Tulip®         Visit product page »	Conichrome™	IGTCFS		X
  Cook Celect®         Visit product page »	Conichrome	IGTCFS-CELECT		X
  Gianturco-      Roehm Bird's Nest®         Visit product page »	Stainless Steel	BNF		X
  Vital-Port® Systems
  Dual Chamber      Titanium–Petite         Visit product page »	Titanium	IP		X
  Dual Chamber      Titanium–Standard         Visit product page »	Titanium	IP		X
  MRI–Petite         Visit product page »	Titanium	IP		X
  MRI–Standard         Visit product page »	Titanium	IP		X
  Titanium–Mini         Visit product page »	Titanium	IP		X
  Titanium–Petite         Visit product page »	Titanium	IP		X
  Titanium–Standard         Visit product page »	Titanium	IP		X
  Titanium for Peripheral      Placement–Mini         Visit product page »	Titanium	IP		X

  Conichrome is a trademark of Carpenter Technologies. Inconel is a registered trademark of Huntington Alloys Corporation.

• Zilver® Self-Expanding Stent

  Nonclinical testing has demonstrated that the Zilver Self-Expanding Stent is MR 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 (for a single stent at 1.5 tesla) and 15 minutes of scanning (for a single stent at 3 tesla and a pair of overlapping stents at 1.5 and 3 tesla), respectively.

  In nonclinical testing, the Zilver Self-Expanding Stent produced maximum temperature rises of 0.1, 3.8, 0.8, and 0.1 degrees C (for a single stent at 1.5 tesla, a pair of overlapping stents at 1.5 tesla, a single stent at 3 tesla, and a pair of overlapping stents at 3 tesla, respectively) at whole-body averaged specific absorption rates (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 (for a single stent at 1.5 tesla) and 15 minutes (for a single stent at 3 tesla and a pair of overlapping stents at 1.5 and 3 tesla) of MR scanning in a 1.5 tesla/64 MHz GE Healthcare MR scanner, a 1.5 tesla Magnetom Siemens Medical Solutions MR Scanner (to evaluate a pair of overlapping stents), and a 3 tesla Excite GE Healthcare MR scanner.

  MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the Zilver Self-Expanding Stent. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic implant.

  Heating in the MRI environment for stents with fractured struts is not known.

• Embolization Coils - Stainless Steel

  For patients implanted with stainless steel coils, recent testing shows that these coils are MR Conditional.

  Nonclinical testing has demonstrated that the standard embolization coil (Stainless Steel) is MR Conditional according to ASTM F2503. A patient with this coil may be scanned safely anytime after placement under the following conditions.

  • Static magnetic field of 3.0 tesla or less
  • Maximum spatial magnetic gradient of 1,600 gauss/cm or less
  • Maximum MR 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)

  Static Magnetic Field
  The static magnetic field for comparison to the above limits is the static magnetic field that is pertinent to the patient (i.e., outside of scanner covering, accessible to a patient or individual).

  MRI-Related Heating
  In nonclinical testing, the standard embolization coil (stainless steel) produced a maximum temperature rise of 1.8 °C during 15 minutes of MR imaging (i.e., for one scanning sequence) performed in a MR 3 tesla system (General Electric Excite, Software 14X.M5) at an MR 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 Artifact
  MR image quality may be compromised if the area of interest is within approximately 75 mm of the position of the standard embolization coil (stainless steel) as found during nonclinical testing using T1-weighted, spin echo and gradient echo pulse sequence in a 3.0 tesla MR system (Excite, General Electric Healthcare, Milwaukee, WI). Therefore, it may be necessary to optimize MR imaging parameters for the presence of this coil.

  For U.S. Patients Only
  Cook recommends that the patient register the MR 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 95382
  Phone:	888.633.4298 (toll free) 209.668.3333 from outside the U.S.

• Gianturco-Roehm Bird’s Nest® Vena Cava Filter

  Nonclinical testing has demonstrated that the Gianturco-Roehm Bird's Nest Vena Cava Filter is MR Conditional. According to the article “MR Imaging of the Bird's Nest Filter” by Alyssa T. Watanabe, “No complication or symptomatic filter displacement was encountered as a result of MR imaging performed at 1.5 T.” The article also states that the filters created significant local artifact distortion on MR images; however, diagnostic images of the pelvis, spine and brain may still be obtained.

  MRI diagnostic procedures should be postponed for six weeks following filter implantation to ensure device incorporation into the vessel wall.

• Formula 418® Balloon Expandable Biliary Stent

  Nonclinical testing has demonstrated that the Formula biliary stent is MR Conditional. A patient with this stent may undergo MRI immediately after placement under the following conditions:

  • Static magnetic field of 3.0 tesla or less
  • Maximum spatial gradient magnetic field of 720 gauss/cm
  • Maximum MR system reported whole-body averaged specific absorption rate (SAR) of 3.0 W/kg for 15 minutes of scanning

  In nonclinical testing, the Formula biliary stent produced a temperature rise of less than 1°C at an MR-system-reported maximum whole-body averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of MR scanning in a 3 tesla system (Excite, Software G3.0-052B, GE Healthcare).

  MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the Formula biliary stent. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic implant. The effect of heating in the MRI environment for overlapping stents or stents with fractured struts is unknown.

• Günther Tulip™ Vena Cava Filter

  Nonclinical testing has demonstrated that the Günther Tulip Vena Cava Filter is MR Conditional. It can be scanned safely immediately after placement under the following conditions:

  • Static magnetic field strengths of 3.0 tesla or less
  • Maximum spatial gradient field of 525 gauss/cm or less
  • Maximum whole-body averaged specific absorption rate (SAR) of 3.0 W/kg for 15 minutes of scanning

  In nonclinical testing, the Günther Tulip Vena Cava Filter produced a temperature rise of less than 0.6°C at a maximum whole-body averaged specific absorption rate (SAR) of 3.0 W/kg for 15 minutes of MR scanning in a 3.0 tesla MR system using a transmit/receive body coil (Excite, Software G3.0-052B, GE Healthcare, Milwaukee, WI).

  MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the Günther Tulip Vena Cava Filter. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic implant.

• Hilal Embolization Microcoils™

  Hilal Embolization Microcoils are manufactured from a platinum composition that has been shown to have no ferromagnetic response. Through nonclinical testing, embolization coils manufactured of this material have been shown to be MR Conditional. A patient with one of these implants can be safely scanned immediately after placement under the following conditions:

  • Static magnetic field strengths of 3.0 tesla or less
  • Maximum spatial gradient field of 330 gauss/cm
  • Maximum MR system whole-body averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning

  In this testing, platinum embolization coils produced a temperature rise of greater than 0.5°C at a maximum whole-body averaged specific absorption rate (SAR) of 2.0 W/kg for 20 minutes of MRI. The effect of heating for other conditions, multiple coils or overlapping coils is unknown.

  MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of platinum embolization coils.

• Cook-Swartz Doppler Flow Probe

  WARNING–MR UNSAFE

  Do not expose patient to an MRI procedure while a Cook-Swartz Doppler Flow Probe is implanted. Substantial MRI-related heating of the Doppler flow probe may occur. Doppler flow probe must be removed prior to any MRI procedure.

• MReye® Embolization Coils

  Through nonclinical testing, the MReye Embolization Coil has been shown to be MR Conditional. It can be scanned safely immediately after placement under the following conditions:

  • Static magnetic field strengths of 3.0 tesla or less
  • Maximum spatial gradient of 330 gauss/cm
  • Maximum whole-body averaged specific absorption rate (SAR) of 2.0 W/kg for 20 minutes of MRI

  The MReye Embolization Coil will not migrate in this MRI environment. Nonclinical testing has not been performed to rule out the possibility of device migration at static magnetic field strengths higher than 3.0 tesla and a maximum spatial gradient higher than 330 gauss/cm.

  In this testing, the MReye Embolization Coil produced a temperature rise of greater than or equal to 0.6°C at a maximum whole-body averaged specific absorption rate (SAR) of 2.0 W/kg for 20 minutes of MRI. The effect of heating in the MRI environment for other conditions, multiple coils or overlapping coils is unknown.

  MRI image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the MReye Embolization Coil.

• MReye Flipper® Detachable Embolization Coils

  Through nonclinical testing, the MReye Flipper Detachable Embolization Coil Delivery System has been shown to be MR Conditional. It can be scanned safely immediately after placement under the following conditions:

  • Static magnetic field strengths of 3.0 tesla or less
  • Maximum spatial gradient of 330 gauss/cm
  • Maximum whole-body averaged specific absorption rate (SAR) of 2.0 W/kg for 20 minutes of MRI

  Embolization coils manufactured of Inconel will not migrate in this MRI environment. Nonclinical testing has not been performed to rule out the possibility of device migration at static magnetic field strengths higher than 3.0 tesla and a maximum spatial gradient higher than 330 gauss/cm.

  In this testing, the MReye Flipper Embolization Coil produced a temperature rise of greater than or equal to 0.6°C at a maximum whole-body averaged specific absorption rate (SAR) of 2.0 W/kg for 20 minutes of MRI. The effect of heating in the MRI environment for other conditions, multiple coils or overlapping coils is unknown.

  MRI image quality may be compromised if the area of interest is in the same area or relatively close to the position of the MReye Flipper Embolization Coil.

• MReye® Needles for Magnetic Resonance Imaging

  Cook’s interventional MReye® Needles are used for initial puncture and positioning control as well as biopsies and other interventional procedures in combination with magnetic resonance imaging.

  • MReye products are created from a nonferromagnetic material that helps prevent disturbing artifacts.
  • MReye needles are recommended for use with MRI scanners not exceeding 1.5 tesla.

  To see different-sized images of the needle, try these scanner parameters:

  • To see an image of the needle at a ratio of 1:1, select a spin echo sequence (TR/TE 200 ms/15 ms).
  • To see an image of the needle enlarged approximately 2:1, select a gradient echo sequence (TR/TE/flip angle 336 ms/15 ms/90°).

• Nester® Embolization Coils

  Nester Embolization Coils are manufactured from a platinum composition that has been shown to have no ferromagnetic response. Through nonclinical testing, embolization coils manufactured of this material have been shown to be MR Conditional. A patient with one of these implants can be scanned safely immediately after placement under the following conditions:

  • Static magnetic field strengths of 3.0 tesla or less
  • Maximum spatial gradient field of 330 gauss/cm
  • Maximum MR system whole-body averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning

  In this testing, platinum embolization coils produced a temperature rise of greater than 0.5°C at a maximum whole-body averaged specific absorption rate (SAR) of 2.0 W/kg for 20 minutes of MRI. The effect of heating for other conditions, multiple coils or overlapping coils is unknown.

  MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of platinum embolization coils.

• Tornado® Embolization Coils

  Tornado Embolization Coils are manufactured from a platinum composition that has been shown to have no ferromagnetic response. Through nonclinical testing, embolization coils manufactured of this material have been shown to be MR Conditional. A patient with one of these implants can be scanned safely immediately after placement under the following conditions:

  • Static magnetic field strengths of 3.0 tesla or less
  • Maximum spatial gradient field of 330 gauss/cm
  • Maximum MR system whole-body averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning

  In this testing, platinum embolization coils produced a temperature rise of greater than 0.5°C at a maximum whole-body averaged specific absorption rate (SAR) of 2.0 W/kg for 20 minutes of MRI. The effect of heating for other conditions, multiple coils or overlapping coils is unknown.

  MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of platinum embolization coils.

• Vital Port® System

  Nonclinical testing demonstrated that the Vital-Port Vascular Access Ports are MR Conditional. A patient with one of these implants can be safely scanned immediately after placement under the following conditions:

  • Static magnetic field of 3.0 tesla or less
  • Maximum spatial gradient magnetic field of 720 gauss/cm
  • Maximum MR system reported whole-body averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning

  In nonclinical testing, the vascular access ports produced maximum temperature increases of less than or equal to 0.7°C at maximum MR system reported whole-body averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of MR scanning in a 3 tesla MR system using a transmit/receive body coil (Excite, software G3.0-052B, GE Healthcare, Milwaukee, WI).

  MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the vascular access ports. Therefore, it may be necessary to optimize MR imaging parameters to compensate for the presence of one of these implants.

• Zenith TX2® TAA Endovascular Graft

  
    (excerpted from IFU)

  MRI Information
  Non-clinical testing has demonstrated that the Zenith TX2 TAA Endovascular Graft with Pro-Form is MR Conditional. It can be scanned safely under the following conditions:

  1.5 Tesla Systems:

  • Static magnetic field of 1.5 Tesla
  • Spatial gradient field of 450 Gauss/cm
  • Maximum whole-body-averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning.

  In non-clinical testing, the Zenith TX2 TAA Endovascular Graft with Pro-Form produced a temperature rise of less than 1.4 °C at a maximum whole-body-averaged specific absorption rate (SAR) of 2.8 W/kg for 15 minutes of MR scanning in a 1.5 Tesla Magnetom, Siemens Medical Magnetom MR scanner. The maximum whole-body-averaged specific absorption rate (SAR) was 2.8 W/kg, which corresponds to a calorimetry measured value of 1.5 W/kg.

  3.0 Tesla Systems:

  • Static magnetic field of 3.0 Tesla
  • Spatial gradient field of 720 Gauss/cm
  • Maximum whole-body-averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning

  In non-clinical testing, the Zenith TX2 TAA Endovascular Graft with Pro-Form produced a temperature rise of less than 1.9 °C at a maximum whole-body-averaged specific absorption rate (SAR) of 3.0 W/kg for 15 minutes of MR scanning in a 3.0 Tesla, Excite, GE Electric Healthcare MR scanner. The maximum whole-body-averaged specific absorption rate (SAR) was 3.0 W/kg, which corresponds to a calorimetry measured value of 2.8 W/kg.

  The image artifact extends throughout the anatomical region containing the device, obscuring the view of immediately adjacent anatomical structures within approximately 20 cm of the device, as well as the entire device and its lumen, when scanned in non-clinical testing using the sequence: Fast spin echo in a 3.0 Tesla, Excite, GE Electric Healthcare, with G3.0-052B software, MR system with body radiofrequency coil.

  For all scanners, the image artifact dissipates as the distance from the device to the area of interest increases. MR scans of the lower extremities may be obtained without image artifact. Image artifact may be present in scans of the abdominal, upper extremity, and head and neck region, depending on distance from the device to the area of interest.

  Clinical information is available on six patients who received MRI scans during the course of the clinical trial. There have been no reported adverse events or device problems in any of these patients as a result of having received an MRI. Additionally, there have been approximately 3,000 patients implanted with Zenith TAA Endovascular Grafts worldwide, in which there have been no reported adverse events or device problems as a result of MRI.

  Cook recommends that the patient register the MR 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 95382
  Phone:	888.633.4298 (toll free) 209.668.3333 from outside the U.S.
  Fax:	209.669.2450
  Web:	www.medicalert.org

Products Containing Latex

Some Cook product packaging contains a natural rubber latex warning on the label. These products contain latex that can be contacted directly or indirectly with normal use of our product. An example of indirect contact is when a fluid contacts the latex and subsequently comes in contact with the patient. Additionally, we assure that our packaging materials do not contain latex.

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