Implant MRI Safety
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Demonstrating the safety of implants with long leads (a pacemaker and a deep brain stimulator) during MRI scans in the Virtual Population.

 

 

Simulation of local RF heating of a pacemaker lead in a 1.5T MRI.

 

 

Multiple routing paths can be efficiently screened in parametric simulations with the help of precomputed libraries.

Implant MRI Safety

 
Expertise & Infrastructure

The IT’IS Foundation runs a dedicated group for customized research solutions in the area of MRI implant safety. IT’IS is your partner of choice as it (1) has pioneered the development of robust methods for the safety testing of Active Implantable Medical Devices (AIMD) and has contributed significantly to ISO/TS 10974, (2) applied these methods to a wide range of medical implants, (3) has detailed knowledge about the intricacies of regulatory agencies and the corresponding processes due to their active participation and membership in IEC/ISO standard groups, as well as (4) experience in interacting with the US Food and Drug Administration (FDA), and other regulators on numerous successful projects.

The group’s Yellow Submarine Laboratory is equipped with the most advanced tools including a PiX system, a MITS 1.5 and 3T system, the latest DASY6 RX90L with DASY52NEO licenses, and a wide range of specialized probes, including hardened probes designed specifically for MRI environments. With more than 100 Sim4Life licenses, including the Virtual Population 3.x and multiple animal models, and several High Performance Computers (HPC) ranging from Graphics Processing Unit (GPU) clusters to supercomputers, our interdisciplinary research team can tackle highly specific and complex research tasks with superior innovation and efficiency – while ensuring compliance to national and international standards.

 

Select Customized Research Projects of the Past Years
  • Studied the interaction between the MR fields and implants, and methods to mitigate RF pickup;
  • Developed methods for demonstrating MRI safety of cardiovascular implants (in collaboration with a leading manufacturer);
  • Demonstrated MR safety of cochlear implants based on temperature evaluations using Tier-4 of IEC/ISO 10974 (i.e., full 3D simulations);
  • Developed methods for demonstrating MRI safety of neuro-stimulators, including support (reports/hearing) during the FDA submission process;
  • Carried out a pilot study for demonstrating the safety of a class of passive implants without evaluating individual implants.

 

Solutions Beyond State-of-the-Art

As many of the current methods for demonstrating MR safety of implants are still too conservative (i.e., overestimating the risks and thereby hindering technology unnecessarily) and - most importantly - incomplete, the IT'IS Foundation is committed to expanding its activities collectively with potential partners. We are also interested in answering open questions related to the interference of other strong EM sources with implants, such as wireless power transfer systems.

 

Contact

We look forward to discussing with you how we can best support your R&D initiatives and regulatory submissions – simply call us at +41 44 245 96 96 or send us an email at customized@itis.swiss.

 

RELEVANT PUBLICATIONS

Yao, A., Zastrow, E., Cabot, E., Lloyd, B., Schneider, B., Kainz, W. & Kuster, N. Anatomical Model Uncertainty for RF Safety Evaluation of AIMD under MRI Exposure. Bioelectromagnetics,
Liorni, I., Neufeld, E., Kühn, S., Murbach, M., Zastrow, E., Kainz, W. & Kuster, N. Novel Mechanistic Model and Computational Approximation for Electromagnetic Safety Evaluations of Electrically Short Implants. Physics in Medicine and Biology, 63(22), 2018
Yao, A., Zastrow, E. & Kuster, N. Data‐Driven Experimental Evaluation Method for the Safety Assessment of Implants With Respect to RF‐Induced Heating During MRI. Radio Science, 53(6):700-709, 2018
Corcoles, J., Zastrow, E. & Kuster, N. On the estimation of the worst-case implant-induced RF-heating in multi-channel MRI. Physics in Medicine and Biology, 62(12):4711-4727, 2017
Murbach, M., Neufeld, E., Cabot, E., Zastrow, E., Corcoles, J., Kainz, W. & Kuster, N. Virtual Population-Based Assessment of the Impact of 3 Tesla Radiofrequency Shimming and Thermoregulation on Safety and B1+ Uniformity. Magnetic Resonance in Medicine, 76(3):986-997, 2016
Corcoles, J., Zastrow, E. & Kuster, N. Convex Optimization of MRI Exposure for Mitigation of RF-Heating from Active Medical Implants. Physics in Medicine and Biology, 60(18):7293-7308, 2015
Murbach, M., Zastrow, E., Neufeld, E., Cabot, E., Kainz, W. & Kuster, N. Heating and Safety Concerns of the Radio-Frequency Field in MRI. In Current Radiology ReportsCurrent Radiology Reports, 3(12), Springer, 2015
Kyriakou, A., Christ, A., Neufeld, E. & Kuster, N. Local Tissue Temperature Increase of a Generic Implant Compared to the Basic Restrictions Defined in Safety Guidelines. Bioelectromagnetics, 33(5):366-374, 2012
Neufeld, E., Gosselin, M.C., Murbach, M., Christ, A., Cabot, E. & Kuster, N. Analysis of the Local Worst-Case SAR Exposure Caused by an MRI Multi-transmit Body Coil in Anatomical Models of the Human Body. Physics in Medicine and Biology, 56(15):4649-4659, 2011
Neufeld, E., Kühn, S., Szekely, G. & Kuster, N. Measurement, Simulation and Uncertainty Assessment of Implant Heating During MRI. Physics in Medicine and Biology, 54(13):4151-4169, 2009