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Medtronic begins clinical trial for pacemaker system

Medtronic has reported the start of a US clinical trial to confirm the safety and efficacy of the Medtronic EnRhythm MRI SureScan pacing system, a pacemaker system to be developed and tested specifically for safe use in Magnetic Resonance Imaging or 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 pacemaker incorporates all diagnostic and therapeutic features of the commercialized Medtronic EnRhythm pacemaker, including an exclusive pacing mode called MVP or Managed Ventricular Pacing, which enables the device to be programmed to deliver pacing pulses to the right ventricle only when necessary. Recent clinical studies have shown that reducing this pacing stimulation may reduce the patient’s risk of developing heart failure and atrial fibrillation.