MRI-Friendly Pacemaker Approved02/08/11
TUESDAY, Feb. 8 (HealthDay News) -- The first heart pacemaker
designed to be used safely during certain MRI exams has been
approved by the U.S. Food and Drug Administration.
A pacemaker produces electrical pulses designed to prevent a
slow or irregular heartbeat. An MRI combines a powerful magnetic
field, a computer and radio frequency pulses to produce detailed
pictures of the body's inner organs and tissues.
Up to now, people with pacemakers have been advised not to have
an MRI, which has the potential to interfere with a pacemaker's
settings and may cause a pacemaker's wiring to overheat, the FDA
said in a news release.
The Revo MRI SureScan Pacing System has a built-in function
that's meant to be turned on before a person undergoes an MRI. Even
with the newly approved device, however, an MRI can only be used on
certain people, on certain parts of the body, and under the
supervision of specially trained technicians, the agency said.
Of 211 people implanted with the device who had an MRI during
clinical testing, none had MRI-related complications, the FDA
The Revo device is produced by Medtronic Inc., based in Mounds
The FDA has more about
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