MRI Guidelines for VNS Therapy®

MRI can be safely performed on patients with VNS Therapy provided that specified guidelines are followed.

Safe Zone

MR Exclusion ZoneNote: imaging techniques such as

x-ray, computed tomography, and ultrasound are safe to perform

in the MR exclusion zone.

2014 Improved

MRI GuidelinesEFFECTIVE. ENDURING.

EMPOWERING.

VNS Therapy SystemThe VNS Therapy system (generator and lead), usually located between C7 and T8 vertebrae, must not be exposed to the radio frequency (RF) field.

Safe MRI conditions

2

Complete VNS Therapy system

OR

Suspected lead break

OR

Lead only >2 cm remaining

Allowable imaging zones See graphic on front cover Full body

RF coil type Head or local ONLY Any

RF coil mode Transmit/receive ONLY Any

Static magnetic field 3T or 1.5T 3T or 1.5T

MRI configuration Closed-bore Closed-bore

MRI operating mode Normal Normal

Spatial gradient field ≤720 gauss/cm ≤720 gauss/cm

Head-averaged SAR ≤3.2 W/kg ≤3.2 W/kg

*Equivalent to clipping the lead at the anchor tether.

Performing MRI is safe when the guidelines below are followed

Lead only ≤2 cm remaining*

Pre- and Post-MRI instructions

3

Pre-MRI instructionsAn appropriate healthcare professional with access to a VNS Therapy

programming system must prepare the VNS Therapy generator before the patient enters an MR system room.

P Interrogate the VNS Therapy generator* and record the generator settings

P Perform System Diagnostics to ensure proper operation of the generator

P Reprogram the Output Current parameter settings for Normal Mode, Magnet Mode, and AutoStim Mode† as follows:

– Output Current (mA): 0.0 – Mag. Current (mA): 0.0 – AutoStim Current (mA): 0.0 and Seizure Detection “OFF”

P Interrogate the generator* to verify that programming was successful

P Verify that placement of the VNS Therapy system is located between the C7 and T8 vertebrae

P Instruct the patient to notify the MR system operator of pain, discomfort, heating, or other unusual sensations so the operator can terminate the procedure, if needed

Post-MRI instructionsAfter the MRI procedure, an appropriate healthcare professional with access to a VNS Therapy programming system should assess the condition of the VNS Therapy system.

P To assess the VNS Therapy system: – Interrogate the VNS Therapy generator – If the generator was reset during the scan, reprogram the serial number,

patient ID, and implant date, as needed – Program the patient’s therapeutic parameters as they were before the

MRI procedure – Perform System Diagnostics. Results should indicate Impedance=OK – Interrogate the generator again to confirm that reprogramming was successful

* When an interrogation is performed by the programming software, the generator serial number, implant date, stimulation parameters, and generator operating time are automatically logged in the programmer database. This information may be retrieved from the database at any time after interrogation.

†Available on select generator models only.

• Seizure reduction that improves and is maintained over time1,2

• Proven improvement in mood and quality of life, independent of seizure control3

• Nonpharmacological side effects typically decrease over time2,4

• Nondrug adjunctive therapy that complements other treatment options

Additional MRI considerations• Only the implanted VNS Therapy system components are safe for MRI. All other

VNS Therapy components (eg, programming wand, programming computer, patient magnet) are MR unsafe and must not be brought into the MRI scanner room.

• A transmit RF body coil can only be used if the VNS Therapy system has been removed and ≤2 cm of lead remains in the body. Surgical removal of the VNS Therapy system will be required if it is necessary to perform MRI using a transmit RF body coil.

REFERENCES: 1. Elliott RE, Morsi A, Kalhorn SP, et al. Vagus nerve stimulation in 436 consecutive patients with treatment-resistant epilepsy: long-term outcomes and predictors of response. Epilepsy Behav. 2011;20(1):57-63. 2. Morris GL Ill, Mueller WM; and The Vagus Nerve Stimulation Study Group E01-E05. Long-term treatment with vagus nerve stimulation in patients with refractory epilepsy. Neurology. 1999;53(7):1731-1735. 3. Morris GL III, Gloss D, Buchhalter J, Mack KJ, Nickels K, Harden C. Evidence-based guideline update: vagus nerve stimulation for the treatment of epilepsy. Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2013;81(16):1453-1459. 4. Ben-Menachem E. Vagus nerve stimulation, side effects, and long-term safety. J Clin Neurophysiol. 2001;18(5):415-418.

VNS Therapy—foundational treatment with the potential to change the course of drug-resistant epilepsy

©2014 Cyberonics, Inc. All rights reserved. Cyberonics® and VNS Therapy® are registered trademarks of Cyberonics, Inc.

2014MRIG15-11-1000-WW

www.cyberonics.com

CYBERONICS, INC. 100 Cyberonics Boulevard Houston, Texas 77058 Tel: +1.800.332.1375 Fax: +1.281.218.9332

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For more information about performing MRI on patients with VNS Therapy, please consult the VNS Therapy System Physician’s Manual, available at: www.cyberonics.com/manuals

Please see important safety information provided by your Cyberonics Representative or visit www.cyberonics.com