New MRI safe internal defibrillator wins first approval in America

17th September 2015

An internal defibrillator designed to be safe for patients needing an MRI scan has got its first approval in America.

The new implantable cardioverter defibrillator (ICD) from Medtronic has been approved by the US Food and Drug Administration (FDA).

The device, called the Evera MRI ICD, has changes to the software and hardware to make it compatible with magnetic resonance imaging (MRI).  

It’s long been considered unsafe for people with most ICDs to have MRI scans because they generate a strong magnetic field that could affect the devices and cause the wires to overheat.

The FDA approval is based on data from a trial involving 275 patients implanted with the MRI-compatible ICD some of whom had a series of full-body MRI scans—including scans of the chest, thoracic spine, cervical spine, and head. The results of the study, which showed there were no complications from the MRI, were presented at the Heart Rhythm Society 2015 scientific sessions.

Medtronic said it expects the newly approved system, which includes the Evera MRI ICD and MRI-safe leads, to be available for doctors in America this month.

A second MRI-compatible ICD (Iforia from Biotronik) has also undergone testing, including a safety study. However it has yet to get FDA approval.

Also see In Ten Years' Time All ICDs will be MRI compatible