MedNews

  • Drug Industry News
  • FDA News & Alerts
  • Health & Medical News
You are here: Home / FDA News & Alerts / New Pacemaker Can Be Used Safely During MRI Exams

New Pacemaker Can Be Used Safely During MRI Exams

February 8, 2011 By MedNews Leave a Comment

The U.S. Food and Drug Administration today approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams.

Pacemakers are surgically implanted medical devices that generate electrical impulses to treat irregular or stalled heart beats. MRIs use a powerful magnetic field, radio frequency pulses and an internal computer to produce detailed images of organs, soft tissues, bone, and other internal body structures not available with other imaging methods.

About half of all patients with pacemakers may require an MRI, but are advised not to have one because an MRI’s magnetic and radiofrequency fields can disrupt the pacemaker’s setting or cause wires to overheat, resulting in unintended heart stimulation, device electrical failure, or tissue damage.

The Revo MRI SureScan Pacing System includes a function that is turned on before a scan to prepare patients for the MRI. The pacemaker’s use in MRIs is limited to certain patients, certain parts of the body, and certain scanning parameters. The FDA also is requiring 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,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “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.”

The FDA reviewed results from one clinical trial of 484 patients. Of those, 464 were successfully implanted with the device and then randomized to receive or not receive an MRI. None of the 211 who underwent an MRI experienced an MRI-related complication. The clinical results confirmed earlier data from animal studies, computational modeling, and other nonclinical research.

Revo is manufactured by Medtronic Inc. of Mounds View, Minn.

via Press Announcements > FDA approves 1st pacemaker designed to work safely during some MRI exams.

Filed Under: FDA News & Alerts, Heart Attack Tagged With: Inc., Medtronic, pacemaker, SureScan Pacing System



Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Search



Tag Cloud

alcohol alzheimers asthma breast cancer cancer children cholesterol dementia depression Diabetes diet drug abuse exercise fda flu food genetics geriatrics h1n1 heart heart attack heart disease high blood pressure HIV/AIDS hormone therapy hypertension lungs menopause mrsa NIH obesity pain pediatrics pregnancy prostate cancer seniors sleep smoking statistics stroke sun swine flu teens USA women's health

Recent Comments

  • Mia Fritz on Health Benefits of Dark Chocolate
  • Shilpa on Why Too Much Iron Can Be Dangerous
  • Racheal on Teen Pregnancy May Be Reduced by Sex Education in Schools, Says Study
  • Don on Prilosec, Nexium and Prevacid Tied to Higher Risk of Pneumonia
  • Meso on Brain Changes in Elderly Can Affect Mobility and Balance
  • About Us
  • Contact

Copyright © 2023 Mednews · Log in