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Medtronic Viewpoint

Medtronic does not support the off-label use of its products and believes that the safe use of implantable cardiac devices in the MR environment cannot be guaranteed until devices are designed to be safe from the ground up. And such devices must be backed by rigorous scientific testing as well as review from appropriate regulatory agencies.

Medtronic recognizes that under certain circumstances, physicians will determine that the medical benefit of conducting an MRI on a patient with an implanted cardiac device outweighs the associated risks. But Medtronic cautions the scientific community about drawing conclusions from limited studies that have reported no adverse events. MRI experts Kanal and Gimbel clearly state: ...failing to identify an adverse event is not equivalent to demonstrating safety1... in small studies with products not intended for the MR environment.

This is especially true since the hazards associated with scanning devices have a low frequency of occurrence. Furthermore, research needs to account for numerous variables, including inconsistency among MRI manufacturers, lead type and length, anatomical position of implant, and scan parameters. All these variables can change with the introduction of new cardiac devices and leads, and the continuous evolution of MRI technology.

None of Medtronic's current products are approved for use in the MR environment, but Medtronic is vigorously addressing this unmet clinical need by designing our future device systems to be safe in MRI scanners by design, not by chance. Physicians and their patients should accept nothing less than this commitment to safety and quality.

For other industry and government viewpoints, refer to the April 2005 issue of PACE.

References
  1. Gimbel J and Kanal E. Can patients with implantable pacemakers safely undergo magnetic resonance imaging? J Am Coll Cardiol. 2004;43:1325-1327.

 

 

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