Medtronic Receives CE Mark for Pacemaker Lead That Will Expand Patient Access to MRI Technology

Medtronic, Inc.

today announced the receipt of CE Mark (Conformité Européenne) and launch of the CapSure Sense MRI™ SureScan® pacing leads, which are approved for use during Magnetic Resonance Imaging (MRI). Medtronic introduced the first MR-Conditional pacemaker system in the world in 2008 and in the U.S. in 2011. The newly approved leads are the smallest MR–Conditional leads available in the world. As passive-fixation leads (which attach to the heart with small tines), they will give physicians an additional option that is MR-Conditional, or designed to be safe for the MRI environment when used per the specified MR Conditions for Use.i Previously approved Medtronic MR–Conditional leads are active fixation leads, which fasten directly into the cardiac tissue.