Medtronic, Inc. (Minneapolis, MN, USA) announced that the company received CE (Conformité Européenne) marking for the 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 range 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 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,” said 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, neurologic 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.
Data show every incremental 1% of unnecessary right ventricular (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; Sophia Antipolis, France) guidelines state that in the selection of pacing mode and device, "the trend is towards dual-chamber pacing with minimization of right ventricular stimulation.” Recent research showed that 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.
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