Medtronic has received European Union approval for the Ensura MRI SureScan pacemaker. This is the third pacemaker from Medtronic that can be used safely within an MRI machine. Medtronic is also awaiting FDA approval to market the system in the US.
Medtronic’s new pacing system provides patients with innovative exclusive technology, MVP® (Managed Ventricular Pacing), which reduces right ventricular pacing by 99 percent. Data show every incremental 1 percent of unnecessary RV pacing increases the risk of atrial fibrillation (AF) by 1 percent and the risk of heart failure hospitalization by 5.4 percent. The European Society of Cardiology (ESC) guidelines state that in the selection of pacing mode and device, “the trend is towards dual chamber pacing with minimization of right ventricular stimulation.” A strategy of minimizing ventricular pacing led to a 40 percent reduction in the relative risk of developing persistent AF compared to conventional dual chamber pacing.
The Ensura MRI SureScan pacing system also features Atrial and Ventricular Capture management (ACM and VCM) with automatic threshold measurements and adjustments; and the pacing system is compatible with the Medtronic CareLink® Network, which allows remote device follow-ups by transmitting arrhythmia and diagnostic device data to a physician’s clinic.
Press release: Medtronic Receives CE Mark for Ensura MRI™ SureScan™ Pacing System Approved for Use in MRI Machines as Labeled …