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:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... locations throughout Arkansas that offers insurance and financial preparation services, is providing an ... Rock City Rescue organization. , Rock City Rescue is a locally recognized nonprofit ...
(Date:10/13/2017)... ... October 13, 2017 , ... PurhealthRX , a leading Health ... technology. Applying the Purzorb™process to full spectrum CBD oil will revolutionize the rapidly growing ... form that can be easily incorporated into liquid products, while reducing costs to end ...
(Date:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association ... Featuring a collection of specialty vendors and unique items from across the nation, this ... health and wellness services offered by the VNA. The boutique will be open ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader in agile ... a contract by the Center for Medicare and Medicaid Services (CMS). The Enterprise ... use of Agile methodologies in a consistent and high value manner across CMS ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest ... its plans to open a flagship location in Covington, LA at 401 N. U.S. ... Go store next to Office Depot in the Holiday Square shopping center. Its location ...
Breaking Medicine News(10 mins):
(Date:9/12/2017)... Sept. 12, 2017   EcoVadis , the leading platform for environmental, ... first annual edition of its Global CSR Risk and Performance Index. The ... EcoVadis, based on Scorecard Ratings that analyzed nearly 800,000 data points across ... ... ...
(Date:9/12/2017)... SAN FRANCISCO , Sept. 12, 2017 /PRNewswire/ ... Lifecycle Management Solutions (VLMS), is pleased to announce ... as a member of its Board of Directors ... 2017. ValGenesis VLMS enables life science companies to ... eliminate the use of paper in this process. ...
(Date:9/9/2017)... -- Dealmed Medical Supplies, New York City,s ... drugs, vaccines, and specialty medical products and services, announced ... acquire Vantage Medical Supplies, a major distributor of medical ... York . ... practices, will operate under the Dealmed name as of ...
Breaking Medicine Technology: