Although it is currently possible for those with pacemakers to get MR scans with close attention, Boston Scientific has now received FDA approval for its ImageReady line of MR-conditional pacemakers, including the Accolade MRI and Essentio MRI pacers and the Ingevity MRI leads.
The Marlborough, Mass.-based company won CE Mark approval for the Ingevity leads back in March 2014. With the full ImageReady system, patients are approved to get full-body MRI scans, which eliminates some of the potential risks of a device malfunctioning due to the scan.
“As shown in the Samurai trial, the ImageReady system gives physicians reassurance that they are implanting pacemakers that are safe in an MRI environment should their patients need scans in the future,” principal investigator Dr. Ronald Berger of Baltimore’s Johns Hopkins Medical Institutions, said in a statement. “The study demonstrated the Ingevity MRI leads had no MR-related complications and very low rates of complications overall.”
Boston Scientific is also reportedly pursuing MRI compatibility for its currently approved implanted cardiac defibrillation (ICD) and cardiac resynchronization therapy (CRT) systems. This pursuit is based on the global ENABLE MRI study initiated early this year.
Photo: Screenshot via Boston Scientific
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