Cardiac Pacemaker: EnRhythm MRI SureScan Pacing System

A new cardiac pacemaker has been developed that permits MRI procedures to be performed in patients by following specific labeling requirements (http://www.medtronic.com/mrisurescan). The EnRhythm MRI SureScan Pacing System (Medtronic, Inc., Minneapolis, MN; was designed to minimize the potential interactions with the electromagnetic fields used for MR systems.

Note: the Advisa MRI SureScan Pacing System is also now available but not in the United States.

Comprehensive labeling information must be reviewed and adhered to ensure patient safety and includes, but is not limited to:

MRI Conditions for Use

Non-clinical testing has demonstrated that the SureScan pacing system is safe for use in the MRI environment when used according to the Instructions for Use. The SureScan pacing system can be scanned in patients under these conditions:

-Closed bore, cylindrical magnet, clinical MRI systems with a static magnetic field of 1.5 Tesla (T) must be used.

-Gradient systems with maximum gradient slew rate performance per axis of ≤ 200 T/m/s must be used.

-Whole body averaged specific absorption rate (SAR) as reported by the MRI equipment must be less than or equal to 2.0 W/kg; head SAR as reported by the MRI equipment must be less than 3.2 W/kg.

-Patients and their implanted systems must be screened per the contraindications in Section 4 of the Instructions for Use.

-Transmit/receive and transmit-only coils (local, volume, interventional, or surface) must not be placed within the isocenter landmark exclusion zone as described in Section 7 of the Instructions for Use. Receive-only coils are permissible.

-Proper patient monitoring must be provided as described in Section 6.3 of the Instructions for Use.

-The patient position restrictions described in Section 7 of the Instructions for Use must be followed.

-The implanted system must consist solely of a SureScan device and SureScan leads as described in Section 8.1 of the Instructions for Use.

The EnRhythm MRI SureScan Pacing System is commercially available in Europe but is not currently available for sale in the United States. In the United States the device is limited by federal law to investigational use only.

For more information please visit http://www.medtronic.com/mrisurescan

[MR healthcare professionals are advised to contact the respective manufacturer in order to obtain the latest safety information to ensure patient safety relative to the use of an MR procedure.]

REFERENCES

http://www.medtronic.com/mrisurescan

Instructions for Use, SURESCAN MRI procedural information for EnRhythm MRI SureScan EMDR01, CapSureFix MRI 5 086MRI, Medtronic, Inc., Minneapolis, MN

Sutton R, Kanal E, Wilkoff BL, et al. Safety of magnetic resonance imaging of patients with a new Medtronic EnRhythm MRI SureScan pacing system: clinical study design. Trials. 2008 Dec 2;9:68.