Second Generation MRI-Friendly Pacemaker Approved by the FDA

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The Advisa DR MRI SureScan, a pacemaker by Medtronic, specifically designed for use with MRI scanners, was just approved by the FDA.  This new pacemaker is Medtronic’s second generation version, which has new important features added to it and is the only pacemaker on the market to be approved by the FDA for use with MRI.

Medtronic said that this product will be launched immediately, and includes the Advisa MRI device and two CAPSureFix MRI SureScan leads.  Medtronic is sure that this pacemaker will be more successful that the first generation.  Although the first generation sold more than 100,000 pacemakers, the excitement quickly faded, mostly because of the lack of evidence showing any danger with other non-FDA approved devices.

It is important to note that the CMS will not pay for MRI scans for patients with other non-approved devices.  Patients need to be aware that they will have to come out-of-pocket unless they have the Advisa DR MRI SureScan pacemaker.  Save On Medical says that a MRI costs somewhere between $500-2,000, and even with insurance you still typically have to pay about $200-500 out of pocket.

This new pacemaker contains these new, significant features:

  • A complete capture management system, leading to better battery life
  • Higher upper tracking rates, which will allow for quicker heart rates for people exercising
  • Rate drop response to reduce risks of fainting or losing consciousness

Go read the whole article on Medtronic’s new pacemaker!