Improved MRI Guidelines - Cardion

1 MRI Guidelines for VNS Therapy MRI can be safely performed on patients with VNS Therapy provided that specified Guidelines are ZoneMR Exclusion ZoneNote: imaging techniques such as x-ray, computed tomography, and ultrasound are safe to perform in the MR exclusion Improved MRI GuidelinesEFFECTIVE. Therapy SystemThe VNS Therapy system (generator and lead), usually located between C7 and T8 vertebrae, must not be exposed to the radio frequency (RF) MRI conditions2 Complete VNS Therapy system ORSuspected lead break ORLead only >2 cm remainingAllowable imaging zonesSee graphic on front coverFull bodyRF coil typeHead or local ONLYAnyRF coil modeTransmit/receive ONLYAnyStatic magnetic field3T or or configurationClosed-boreClosed-boreMRI operating modeNormalNormalSpatial gradient field 720 gauss/cm 720 gauss/cmHead-averaged SAR W/kg W/kg*Equivalent to clipping the lead at the anchor MRI is safe when the Guidelines below are followedLead only 2 cm

2 Remaining*Pre- and Post-MRI instructions3 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. PInterrogate the VNS Therapy generator* and record the generator settings PPerform System Diagnostics to ensure proper operation of the generator PReprogram the Output Current parameter settings for Normal Mode, Magnet Mode, and AutoStim Mode as follows: Output Current (mA): Mag. Current (mA): AutoStim Current (mA).

3 And Seizure Detection OFF PInterrogate the generator* to verify that programming was successful PVerify that placement of the VNS Therapy system is located between the C7 and T8 vertebrae PInstruct the patient to notify the MR system operator of pain, discomfort, heating, or other unusual sensations so the operator can terminate the procedure, if neededPost-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.

4 PTo 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.

5 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 optionsAdditional 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.

6 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 : 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.

7 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) Therapy foundational treatment with the potential to change the course of drug-resistant epilepsy 2014 Cyberonics, Inc.

8 All rights reserved. Cyberonics and VNS Therapy are registered trademarks of Cyberonics, , INC. 100 Cyberonics Boulevard Houston, Texas 77058 Tel: + Fax: + EUROPE BVBA Airport Plaza - Kyoto Building Leonardo Da Vincilaan 19 1831 Diegem, Belgium Tel: + Fax: + For more information about performing MRI on patients with VNS Therapy, please consult the VNS Therapy System Physician s Manual, available at: see important safety information provided by your Cyberonics Representative or visit