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 $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2016)... CAESAREA, Israel , May 27, 2016 ... developer of the Dario™ Diabetes Management Tool, today announced that ... present at the Marcum MicroCap Conference being held June 1-2 ... LD Micro Invitational, being held June 7-9 in ... Mr. Ben-David will discuss recent corporate and operational milestones, including ...
(Date:5/27/2016)... 2016 Kitov Pharmaceuticals ... on late-stage drug development, today announced the completion ... pivotal batches required for registration of KIT-302 with ... follows Kitov,s announcement in December 2015, ... its primary efficacy endpoint. "We are ...
(Date:5/26/2016)... -- According to a new market report published ... Industry Analysis, Size, Share, Growth, Trends, and Forecast 2015 - ... valued at US$ 5.89 Bn in 2014 and is anticipated ... 2023 to reach US$ 7.99 Bn in 2023. ... free drug delivery devices and the market is estimated based ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... May 27, 2016 , ... An influential resource amongst ... third time to shed lights on the variety of topics detailing why we appreciate ... Appreciation” tackles why this career has gone from being in a major recession to ...
(Date:5/27/2016)... ... May 27, 2016 , ... An educational campaign ... inspiring human-interest stories, courtesy of awareness-driven celebrities and thought leaders. It also provides ... associations and industry leaders such as Bioness. , As patients feel increasingly ...
(Date:5/27/2016)... (PRWEB) , ... May 27, 2016 , ... ... this installment is bolstered by inspiring human interest stories, courtesy of leaders in ... trends and tech within the industry, from leading advocates and associations—namely Jones & ...
(Date:5/27/2016)... ... May 27, 2016 , ... With a team of ... food industries. Aside from its GMP accreditation, Validation Center is also a registered ... products, services and staff. , Validation Center is ISO17025 accredited and only offers ...
(Date:5/26/2016)... Gilsum, New Hampshire (PRWEB) , ... May 26, 2016 , ... ... natural skin care products, has been honored with a 2016 When Work Works Award ... This prestigious award, part of the national When Work Works project administered by the ...
Breaking Medicine News(10 mins):