February 17, 2011

FDA Approves New Pacemaker That is MRI-Safe

Posted in Heart Disease in the News, Helpful Heart Links tagged , , , , , , at 8:39 pm by keepyourhearthealthy


Since the beginning of pacemakers, getting a metal device in your chest has meant that you can never have a diagnostic MRI again.  Now patients have the option of getting a new MRI-safe pacemaker.

A new pacemaker was unanimously approved by the FDA last week which will change the future of cardiology.  The new Revo MRI pacemaker system is manufactured by Medtronic and is already being implanted in patients throughout the US.  It is the first and only pacemaker system which has been shown in studies to be safe during an MRI.

An MRI (Magnetic Resonance Imaging) is a popular diagnostic test which uses very strong magnetic fields to produce images of structures inside the body.  MRI’s are frequently used to view joints, the brain and areas suspected of having cancerous tumors.  Obviously anything which is magnetic would be unsafe for metal objects inside the body.  The magnetic field created during the test creates heat and movement of metal objects.  Some deaths in the past have been reported in patients with pacemakers who underwent an MRI.

The new Revo MRI Surescan Pacing System was tested on 484 patients and found to be perfectly safe during an MRI. There are however, “Conditions of Use” which specify that all parts of the pacemaker must be part of the Revo MRI Surescan system.  This means that the leads as well as the generator have to be implanted from Medtronic’s new system.  You can’t get a “battery change-out” only and expect to undergo an MRI.  The leads would need to be replaced as well.  In addition, this new MRI-safe system also only applies to regular pacemakers.  There are no ICD’s or defibrillators available that are MRI-safe at this time.

Read more about this brand new MRI-safe pacemaker at Medtronic’s website: