Navigation Links
FDA Approves First Pacemaker Deemed Safe During MRIs
Date:2/8/2011

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.

More information

For more on pacemakers, go to the National Library of Medicine.

--HealthDay editors

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


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. FDA Approves First Drug to Prevent Premature Births
2. Swiss agency approves clinical trial of UCI-created neural stem cell therapy
3. ACGME board approves final duty hour and supervision standards for resident education
4. FDA Approves 1st Oral Drug to Reduce MS Relapses
5. FDA approves Merz Pharmaceuticals Xeomin (incobotulinumtoxinA) for the treatment of cervical dystonia and blepharospasm
6. Early detection of cancer: The FDA approves procedure discovered by EPFL researchers
7. FDA approves first human neural stem cell clinical trial to treat brain tumors
8. FDA Approves Stemedica IND for Ischemic Stroke Clinical Trial
9. New York State Office of Mental Health Approves New High Performance Polycarbonate Sheet for Use in All Facilities
10. House of Representatives Approves Health-Care Reform Bill
11. Congress Approves Bill Curbing Internet Tobacco Sales in Victory for Kids and Taxpayers
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Approves First Pacemaker Deemed Safe During MRIs
(Date:5/26/2017)... ... , ... “Just What Happened in the Garden of Eden”: retells the stories of three Bible ... creation of published author, Penelope Colt, mother, trader, horse farmer, artist and a former GM ... was three. At six, they moved to Dayton, Ohio, where Penny graduated high school. ...
(Date:5/26/2017)... (PRWEB) , ... May 26, 2017 , ... Water damage ... Lee, New Jersey School District had left education officials with a number of critical ... replacement of the flooring had to be accomplished with little or no disruption to ...
(Date:5/24/2017)... ... May 24, 2017 , ... In modern research, success depends ... instruments for research and understanding the basic principles that were designed to drive ... innovations in stereo microscopy for brightfield and fluorescence typically used in laboratories working ...
(Date:5/24/2017)... , ... May 24, 2017 , ... Altec ... participation in nVerge 2017 – a one-day technology conference in San Diego, CA. ... solution, which allows users to fully utilize and enhance their Sage ERP solutions by ...
(Date:5/24/2017)... ... May 24, 2017 , ... Drs. Nicholas Rallis and Chris ... spent 10 years as clinical instructors for the reputable Full Mouth Rehabilitation continuing ... the program, private practitioners receive cutting-edge clinical training and learn how to perform ...
Breaking Medicine News(10 mins):
(Date:5/6/2017)... Texas , May 5, 2017   Provista , ... with more than 200,000 customers, today announced Jim Cunniff ... a wealth of executive and business experience to Provista, including ... compounding pharmacy in California . He assumed ... "Jim is a great fit for Provista," says ...
(Date:5/4/2017)... 2017 Clarius Mobile Health, a digital ... scanners this week at the American Congress of ... San Diego, CA from ... the perfect tool for clinicians to easily confirm ... evaluate pregnancy-related complications like ectopic pregnancy and placenta ...
(Date:5/3/2017)... 2017 A Catheterization Laboratory is an ... facility. Commonly referred to as cath lab, this ... imaging technology to give physicians visual access to ... spaces, a team of physicians perform life-saving procedures ... intervention, congenital heart defect closure, stenotic heart valves, ...
Breaking Medicine Technology: