Günther Tulip^® Vena Cava Filter

Nonclinical testing has demonstrated that the Günther Tulip Vena Cava Filter is MR Conditional according to ASTM F2503. A patient with a Günther Tulip 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 MR 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)

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
1.5 Tesla Temperature Rise 
In nonclinical testing, the Günther Tulip Vena Cava Filter produced a maximum temperature change of 3.8°C during 15 minutes of MRI (i.e., for one scanning sequence) performed in a 1.5 tesla MR system (1.5 tesla/64 MHz, Siemens Magnetom Avanto®, Numaris/4 syngo® MR B17) at an MR 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 Günther Tulip Vena Cava Filter produced a maximum temperature change of 5.2°C during 15 minutes of MRI (i.e., for one scanning sequence) performed in a 3.0 tesla MR system (3.0 tesla/128 MHz, Siemens Magnetom Trio®, A Tim System, Numaris/4 syngo MR B17) at an MR system-reported whole-body-averaged SAR of 2.08 W/kg (associated with a calorimetry-measured whole-body-averaged value of 1.71 W/kg). 

Image Artifacts
MR image quality may be compromised if the area to be scanned is within approximately 21 mm of the position of the Günther Tulip Vena Cava Filter. This 21 mm range is based on nonclinical testing with T1-weighted spin-echo and gradient-echo pulse sequences in a 3.0 tesla MR system (Excite, GE Healthcare). If you need to scan an area within 21 mm of the filter, you may have to optimize MR imaging parameters to compensate for the presence of this metallic filter. 

For U.S. Patients Only
Cook recommends that the patient register these MR conditions with the MedicAlert Foundation. The MR conditions disclosed in this document are taken from the product IFU. Contact the MedicAlert Foundation at: 

Mail: MedicAlert Foundation International
2323 Colorado Avenue
Turlock, CA 95382 

Phone: 888.633.4298 (toll free)
209.668.3333 (outside the U.S.) 

Fax: 209.669.2450 

Web: www.medicalert.org         


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