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:1/16/2017)... , January 16, 2017 Bill is ... number of general management and leadership positions with global medical device ... a strong track record of launching new products and building successful ... , Africa and North ... ...
(Date:1/16/2017)... , Jan. 16, 2017 CBDRx, the ... large amounts of phyto-nutrient rich hemp extract to Veteran,s ... donation of their proprietary hemp extract to Veteran,s groups ... the best hemp company in the world and through ... most nutritious, full spectrum phyto-nutrient rich hemp extract available. ...
(Date:1/13/2017)... 13, 2017 /PRNewswire/ - InMed Pharmaceuticals, Inc. ("InMed") (CSE: IN; OTCQB: ... Corporate Finance and Investment Banking at Eli Lilly & Company, ... Mr. Bott brings over 28 years of senior financial and ... ... has established a significant leadership position in financial and ...
Breaking Medicine Technology:
(Date:1/15/2017)... ... 2017 , ... "On Tour is a music themed slideshow production package which ... Austin - CEO of Pixel Film Studios. , On Tour’s new slide presets ... animation of their slideshows. Place each slide on top of another slide or piece ...
(Date:1/15/2017)... ... January 14, 2017 , ... Wondering where to go this ... straight to your door for a romantic, lobster feast in the comfort of your ... Valentine's Day. The dinners will be featured until February 15th, 2017. , Romantic ...
(Date:1/15/2017)... , ... January 15, 2017 , ... ... in Montclair, NJ is pleased to announce that it will be assisting HackensackUMC ... in Montclair and Glen Ridge townships, servicing all surrounding towns. The firm will ...
(Date:1/14/2017)... CA (PRWEB) , ... January 13, 2017 , ... ... on Body and Soul, incorporating a magnesium-rich Mediterranean diet may lower the risk ... Café and Lounge notes that the many health and wellness benefits linked to ...
(Date:1/14/2017)... ... January 14, 2017 , ... "TransFreeze Volume 3 is a self animating masking transition ... in Final Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. ... freeze frame transition from one clip to the next. , To use “Cut-Out ...
Breaking Medicine News(10 mins):