Medtronic Receives CE Mark for MRI-Safe Pacemaker Lead


March 6, 2012

March 6, 2012 — Medtronic Inc. announced the launch of the CapSure Sense MRI SureScan pacing leads, which are approved for use during magnetic resonance imaging (MRI), and the receipt of the CE mark.

The newly approved leads are the smallest MR–conditional leads available. As passive-fixation leads (which attach to the heart with small tines), they give physicians an additional option that is MR-conditional, or designed to be safe for the MRI environment when used per the specified conditions for use. Previously approved Medtronic MR–conditional leads are active fixation leads, which fasten directly into the cardiac tissue.

With approximately 60 million MRI procedures performed worldwide each year, there has been increasing demand for MR–conditional pacing systems. MRI procedures are indicated for 17 percent of pacemaker patients within 12 months of device implant.

“The CapSure Sense MRI SureScan leads address an unmet clinical need for thoroughly tested MRI conditional passive fixation leads," said Gianluca Botto, M.D., director of EPS Unit at St. Anna Hospital in Como, Italy. “With this new lead, there is now a full portfolio of options available for physicians and their patients, when this lead is combined with an MR–conditional device.”

To assure the safety of patients and the effectiveness of the patients’ pacing therapy, the CapSure Sense MRI leads were tested in more than 400,000 scenarios that evaluated different patient body types, scanning locations, MRI scanner types and lead lengths.

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