Medtronic Gets European Approval for Second-Generation MRI-Safe Pacemaker

 

June 19, 2009

June 19, 2009 – Medtronic Inc. today said it received CE (Conformité Européenne) mark for the company's second-generation pacemaker designed, tested, approved for use as labeled with MRI machines, the Advisa DR MRI SureScan pacing system.

The Advisa MRI SureScan pacing system currently is not available for sale in the U.S.

Approximately 2 million Europeans have implanted pacemakers, but these patients are strongly discouraged from receiving MRI scans, a widely practiced diagnostic method for many common diseases and conditions, because their device could interact with MRI machines, potentially affecting the device or patient safety. According to estimates, 50-75 percent of patients worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices.

The Advisa MRI SureScan pacing system is the most advanced pacing system from Medtronic and combines for the first time MRI SureScan with key features from Medtronic pacemakers and defibrillator systems: exclusives such as MVP (Managed Ventricular Pacing), OptiVol Fluid Status Monitoring, and Ventricular and Atrial Capture Management (VCM and ACM). MVP reduces right ventricular pacing by 99 percent). In SAVE PACe, a previous trial of pacemaker patients published in The New England Journal of Medicine, use of Medtronic MVP or Search AV+ modes was proven to dramatically reduce unnecessary right ventricular pacing. This reduction was shown to reduce the development of persistent atrial fibrillation. Further, the 2008 ACC/AHA/HRS Device-Based Therapy Guidelines indicate there may be deleterious effects from even modest levels of ventricular pacing associated with alternative programming modes.

VCM and ACM are intended to automatically adjust impulses for optimal stimulation of the heart's chambers. The device also offers enhanced diagnostics to help assist physicians in the diagnosis of irregular heart rhythms, particularly atrial tachyarrhythmia (AT)/AF. Additionally, upon commercial release, the Advisa MRI SureScan pacing system will be available for remote follow-up via the Medtronic CareLink Network.

For more information: www.medtronic.com

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