FDA Approves First Pacemaker Deemed Safe During MRIs
But use limited to certain patients, certain body parts and certain scanning parameters, agency notes
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 other problems.
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 MRI-related complication.
The results confirmed earlier data from animal studies, computer simulation programs and other nonclinical research.
Revo is manufactured by Medtronic Inc., of Mounds View, Minn.
For more on pacemakers, go to the National Library of Medicine.
Source: SOURCE: Larry A Chinitz, M.D., director, cardiac electrophysiology and the Heart Rhythm Center, NYU Langone Medical Center, New York City; U.S. Food and Drug Administration, news release, Feb. 8, 2011
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