US Food and Drug Administration on Monday approved the first pacemaker
system — produced by medical device giant Medtronic Inc. — that can be
used safely with MRI scanners.
with pacemakers, which generate electrical impulses to treat irregular
or stalled heart beats, have had to forgo MRI scans because of the risk
of the machines’ radiowaves interfering with the heart devices.
estimates that about 200,000 US pacemaker patients opt out of MRI scans
every year even though they play a critical role in making a wide range
of health diagnoses.
Revo MRI SureScan Pacing System has a function that can be turned on
before a scan in order to prepare patients for the MRI machines, which
can be up to 30,000 times more powerful than the Earth’s magnetic field.
The function reduces or eliminates potential MRI hazards.
Rod Gimbel of Cardiology Associates of East Tennessee in Knoxville said
the new pacemaker was “a major technological breakthrough for patients
who need access to MRI.”
pacemaker patients with access to MRI allows detection and treatment of
serious medical conditions such as stroke, cancer and a wide variety of
important neurologic and orthopedic conditions.”
said pacemaker use is growing as the population ages, with about five
million patients worldwide currently outfitted with a pacemaker or
implantable cardioverter-defibrillator. MRI use also has increased, with
about 30 million scans completed in 2007.
approval of the Revo pacemaker represents an important step forward
toward greater device innovation,” said Jeffrey Shuren, director of the
FDA’s Center for Devices and Radiological Health.
patients who meet the parameters for the device will be able to
maintain their critical cardiac therapy while benefiting from the
precise diagnostic capability of an MRI.”
The FDA is requiring cardiologists and radiologists who use the system to receive appropriate training.