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Home Therapies Cardiac Pacing Medtronic Receives CE Mark for CapSure Sense MRI™ SureScan® Pacing Leads

Medtronic Receives CE Mark for CapSure Sense MRI™ SureScan® Pacing Leads

Medtronic SureScan Sense MRI Passive Fixation Leads. www.implantable-device.com

Image Credit: Medtronic

Medtronic today announced the receipt of CE Mark and launch of the CapSure Sense MRI™ SureScan® pacing leads, which are approved for use during MRI procedures.  The newly approved leads are the smallest MR–Conditional leads available in the world with a 5.3 French isodiametric lead body.  The new leads are passive-fixation leads.  Previously approved Medtronic MR–Conditional leads are active fixation leads.

Click here for Medtronic’s product page for the CapSure Sense MRI™ SureScan® Pacing Leads.

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2 Comments  comments 

2 Responses

  1. So I imagine MRI-conditional is not MRI compatible or MRI safe.
    What may than be the conditions under which it is safe?


    • Hi Peter,

      Each company establishes the conditions under which it is safe to conduct an MRI for a patient with a MRI-conditional IPG. For example, the St. Jude Medical™ MRI conditional pacing system can be scanned in patients under the following conditions: horizontal closed bore clinical scanner working in the Normal Operating Mode or First Level Controlled Operating Mode; static magnetic field strength of 1.5 Tesla (T) only; maximum gradient slew rate of 200 T/m/s per axis. These conditions are essentially the same as those established by Medtronic for its MRI-conditional devices. Please see: http://www.medtronic.com/surescan/radiologist.html

      Besides the issues posed by a strong static magnetic field, the conditions are required because the RF pulsing resonance frequency of the MRI system depends on magnetic field strength, so the system’s filters and other aspects need to be designed and tested (and thus labeled) to be safe under very specific conditions.

      Please take a look at: http://www.medtronic.com/surescan/designed-for-mri-safety.html for the various risks and mitigation methods of a MRI-conditional pacemaker.