Navigation Links
FDA Approves 1st Pacemaker Designed to Work Safely During Some MRI Exams
Date:2/8/2011

SILVER SPRING, Md., Feb. 8, 2011 /PRNewswire-USNewswire/ -- 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.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

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.

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/29/2017)... , March 29, 2017 ... report, which provides an exhaustive study of the U.S. ... nearly 242 companies are functional in this market ... With the leading companies, such as GlaxoSmithKline Plc., ... focusing aggressively on various marketing strategies to increase ...
(Date:3/29/2017)... 29, 2017 Research and Markets has announced ... report to their offering. ... The global lifestyle drugs market to grow at a ... report, Global Lifestyle Drugs Market 2017-2021, has been prepared based on ... covers the market landscape and its growth prospects over the coming ...
(Date:3/29/2017)... -- Varian Medical Systems (NYSE: VAR ) announced ... of fiscal year 2017 following the close of regular trading ... followed by a teleconference available to all interested parties at ... the conference call webcast will be available on the company ... and replay: ...
Breaking Medicine Technology:
(Date:3/29/2017)... ... March 29, 2017 , ... AngioGenesis Labs sold 300 bottles ... AngioGenesis Labs, makers of HeartBoost, BrainBest and BeautyBest, achieved these results while doing ... an over the counter heart healthy drink, can reduce Arterial Plaque, Lower Blood ...
(Date:3/29/2017)... ... March 29, 2017 , ... Based on research ... challenges employers face in trying to balance both short-term and long-term benefits demands. ... Adding to the growing complexity, companies are finding that the short-term strategies used ...
(Date:3/29/2017)... ... ... Dr. Angela Cotey, a noted general dentist in Mt. Horeb, is now ... without a referral. Dr. Cotey knows that interceptive orthodontics in Mt. Horeb, ... receive early treatment, they may achieve straight teeth with less treatment in their teenage ...
(Date:3/29/2017)... ... March 29, 2017 , ... How ... other outpatient facilities, and who are the most active developers? , In ... and Healthcare Real Estate Insights (HREI) found that outpatient medical real estate development ...
(Date:3/29/2017)... ... March 29, 2017 , ... Curio Wellness , a premium medical cannabis ... the company’s executive management team with prominent executives from both inside and outside the ... Operating Officer, Ted Dumbauld , who has more than twenty years of business ...
Breaking Medicine News(10 mins):