Medtronic just received European approval for the firm’s Advisa DR MRI™ SureScan™ Pacing System, an implantable pacemaker that has demonstrated safety when worn while undergoing MRI scans. The Advisa has not received FDA approval and therefore is not yet available in the US.
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 percent2. 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.
Press release: Medtronic Receives CE Mark for Second-Generation MRI Pacemaker…
Flashbacks: Positive Results for Medtronic’s MRI-Safe Pacemaker; Developing the Next Generation of DBS Devices; Medtronic Starts Study of MRI Compatible Pacemaker; Is It Now Safe to Send a Patient With a Pacemaker for an MRI Scan?