FDA approves first MRI-safe pacemaker

Feb 08, 2011

The US Food and Drug Administration on Monday approved the first pacemaker system -- produced by medical device giant Medtronic Inc. -- that can be used safely with MRI scanners.

Patients with pacemakers, which generate electrical impulses to treat irregular or stalled heart beats, have had to forgo MRI scans because of the risk of the machines' radiowaves interfering with the heart devices.

Medtronic estimates that about 200,000 US pacemaker patients opt out of MRI scans every year even though they play a critical role in making a wide range of health diagnoses.

Its Revo MRI SureScan Pacing System has a function that can be turned on before a scan in order to prepare patients for the MRI machines, which can be up to 30,000 times more powerful than the Earth's magnetic field.

The function reduces or eliminates potential MRI hazards.

J. Rod Gimbel of Cardiology Associates of East Tennessee in Knoxville said the new pacemaker was "a major technological breakthrough for patients who need access to MRI."

"Providing pacemaker patients with access to MRI allows detection and treatment of serious medical conditions such as stroke, cancer and a wide variety of important neurologic and orthopedic conditions."

Medtronic said pacemaker use is growing as the population ages, with about five million patients worldwide currently outfitted with a pacemaker or implantable cardioverter-defibrillator. MRI use also has increased, with about 30 million scans completed in 2007.

"FDA's approval of the Revo represents an important step forward toward greater device innovation," said Jeffrey Shuren, 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 is requiring cardiologists and radiologists who use the system to receive appropriate training.

Explore further: Experts call for higher exam pass marks to close performance gap between international and UK medical graduates

add to favorites email to friend print save as pdf

Related Stories

MRI machines may damage cochlear implants

Dec 01, 2008

Patients with cochlear implants may want to steer clear of certain magnetic imaging devices, such as 3T MRI machines, because the machines can demagnetize the patient's implant, according to new research published in the ...

Recommended for you

Obese British man in court fight for surgery

Jul 11, 2011

A British man weighing 22 stone (139 kilograms, 306 pounds) launched a court appeal Monday against a decision to refuse him state-funded obesity surgery because he is not fat enough.

2008 crisis spurred rise in suicides in Europe

Jul 08, 2011

The financial crisis that began to hit Europe in mid-2008 reversed a steady, years-long fall in suicides among people of working age, according to a letter published on Friday by The Lancet.

New food labels dished up to keep Europe healthy

Jul 06, 2011

A groundbreaking deal on compulsory new food labels Wednesday is set to give Europeans clear information on the nutritional and energy content of products, as well as country of origin.

Overweight men have poorer sperm count

Jul 04, 2011

Overweight or obese men, like their female counterparts, have a lower chance of becoming a parent, according to a comparison of sperm quality presented at a European fertility meeting Monday.

User comments : 0

More news stories

Cancer stem cells linked to drug resistance

Most drugs used to treat lung, breast and pancreatic cancers also promote drug-resistance and ultimately spur tumor growth. Researchers at the University of California, San Diego School of Medicine have discovered ...

Making graphene in your kitchen

Graphene has been touted as a wonder material—the world's thinnest substance, but super-strong. Now scientists say it is so easy to make you could produce some in your kitchen.