Medtronic has received CE (Conformite Europeenne) mark for Ensura MRI SureScan pacing system. It is approved for use as labeled with MRI machines and is available in select European geographies. The pacing system currently is not approved for sale in the US.
Medtronic said that, with the new SureScan pacing system, patients will have access to full body scans, without positioning restrictions in the MRI scanner. It provides improved technology, MVP (Managed Ventricular Pacing), which reduces right ventricular pacing by 99%.
Data showed that for every 1% increase of unnecessary RV pacing, increases the risk of atrial fibrillation (AF) by 1% and the risk of heart failure hospitalization by 5.4%.
The Ensura MRI SureScan pacing system also features Atrial and Ventricular Capture management (ACM and VCM) with automatic threshold measurements and adjustments and 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.
According to estimates, 50-75% of patients worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices. MRI is the standard of care in soft tissue imaging, providing information not seen with X-ray, ultrasound, or CT scan, and critical for early detection, diagnosis and treatment.
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 minimisation of right ventricular stimulation.’ A strategy of minimising ventricular pacing led to a 40% reduction in the relative risk of developing persistent AF compared to conventional dual chamber pacing.
Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic, said: “Half of the world’s pacemaker implants are from Medtronic, and physicians say the number one unmet need is MRI compatibility. We are pleased to offer physicians a third option from the world’s first portfolio of MR Conditional pacing systems with our exclusive technology for patients who may need access to the critical diagnostics available through MRI.”