Medtronic to Begin Clinical Trial of MRI Safe Pacemaker System

The FDA has granted Minneapolis, MN based Medtronic, Inc. approval to start a United States clinical trial to confirm the safety and efficacy of the Medtronic EnRhythm MRI™ SureScan™ pacing system, the first-ever pacemaker system to be developed and tested specifically for safe use in Magnetic Resonance Imaging (MRI) machines under specified scanning conditions.

The EnRhythm MRI SureScan pacing system consists of the dual-chamber EnRhythm MRI™ SureScan™ pacemaker and CapSureFix MRI™ SureScan™ pacing leads (Model 5086MRI). The first implant in the U.S. clinical trial was performed by Brian Ramza, M.D., Ph.D., director of Electrophysiology Laboratory Services at the Mid America Heart Institute, Saint Luke’s Hospital, Kansas City, Mo.

more information from Medtronic

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