CE Mark for Ensura MRI SureScan Pacing System

Medtronic Inc. announced today the company received CE (Conformité Européenne) Mark for Ensura MRI SureScan pacing system. Ensura MRI is the company’s new option in the second-generation pacing system, available in select European geographies, in a portfolio of devices from Medtronic designed, tested, and approved for use as labeled with MRI machines. Patients with this new SureScan pacing system will have access to full body scans, without positioning restrictions in the MRI scanner. The Ensura MRI SureScan pacing system currently is not approved for sale in the United States.

“Half of the world’s pacemaker implants are from Medtronic, and physicians say the number one unmet need is MRI compatibility,” says Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “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.”

Approximately two million Europeans have implanted pacemakers; however, these patients are strongly discouraged from receiving MRI scans, a widely practiced diagnostic method for many common diseases and conditions, such as cancer, neurological disorders and orthopedic injuries. It is possible current pacing systems could interact with MRI machines, potentially affecting the device or patient safety. 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.

About Ensura MRI Sure Scan Pacing System
Medtronic’s new pacing system provides patients with innovative exclusive technology, MVP (Managed Ventricular Pacing), which reduces right ventricular pacing by 99%.

Data show every incremental 1% of unnecessary RV pacing increases the risk of atrial fibrillation (AF) by 1% and the risk of heart failure hospitalization by 5.4%. 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% 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.