FDA Approves First Pacemaker Deemed Safe During MRIs02/08/11
TUESDAY, Feb. 8 (HealthDay News) --The U.S. Food and Drug
Administration on Tuesday approved the first heart pacemaker
designed to be safe during some MRI scans.
Pacemakers are medical devices implanted in the body to treat
irregular or stalled heart beats. Until now, patients with
pacemakers who needed an MRI were out of luck, since the magnetic
and radiofrequency fields used by the MRI could disturb the
pacemakers' settings or cause wires to overheat, accidentally
shocking the heart, burning tissue, causing electrical failure and
The new pacemaker -- known as the Revo MRI SureScan Pacing
System -- includes a function that is activated before a scan to
prepare patients for the MRI, according to an FDA news release. Its
use in MRI scans, however, is limited to certain patients,
particular parts of the body and certain scanning parameters. The
FDA will require training for cardiologists and radiologists who
use the system.
"FDA's approval of the Revo pacemaker represents an important step forward toward greater device innovation," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in the news release. "Those 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."
"Patients with devices are restricted from having magnetic resonance imaging [MRI] exams," noted Dr. Larry A Chinitz, director of cardiac electrophysiology and the Heart Rhythm Center at NYU Langone Medical Center in New York City. "Sometimes it is a nuisance, sometimes it can be life-threatening. This new pacemaker will begin to attack the problem that these patients face. NYU Langone Medical Center will be the first in New York to implant this new device."
Almost half of those who have a pacemaker may need an MRI at
some point, according to the FDA.
Before approving the new pacemaker, the FDA reviewed results
from a clinical trial of 484 patients. Of those, 464 had the device
implanted and then were chosen at random to receive or not receive
an MRI. Of the 211 who underwent an MRI, none experienced an
The results confirmed earlier data from animal studies, computer
simulation programs and other nonclinical research.
Revo is manufactured by Medtronic Inc., of Mounds View,
For more on pacemakers, go to the
National Library of Medicine.
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