FDA OK's Pacemaker that's safe in MRI

This could be huge news for the thousands of pacemaker wearers - like Mr. Maven - who have to avoid getting potentially lifesaving MRI imaging because of their implanted pacemakers.

-maven

FDA approves 1st pacemaker designed to work safely during some MRI exams

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.

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.



TSA full body scan and your pacemaker

I just got off the phone with the hands down best looking - and most talented - cardiac surgeon in northern Nevada. I wanted the straight skinny on Mr. Maven going through the new body scanners at the airport since he has a pacemaker, or going for the ‘grope’.

As I’ve blogged recently, I simply don’t have issues with either. I’ve been through the full body scan machines, and BFD. Mr. Maven has always been treated with respect over in ‘the special line’, as one with a medical appliance, AKA pacemaker. Again, BFD.

But there’s a lot of conflicting information and downright bullshit out there.

According to Dr. Handsome, unless you are truly “pacemaker dependent” then if you must go through the TSA full body scan, it isn’t likely to do any real ‘damage’ - it’s not going to somehow ‘fry’ the circuitry of your pacemaker or make it jump out of your chest. But the machines do emit electro-magnetic fields, and those can ‘suppress’ the pacemaker function for a fraction of a second or two or three. If you aren’t pacemaker dependent - your heart is simply beats too slow but can beat just fine on it’s own - then the worst that can happen would be that you feel ‘woosey’ or light headed. You might need to sit down. The pacemaker would continue with it’s normal functioning once clear of the body scanners and the electro-magnetic field.

The same thing could happen if a person wearing a pacer leans into the engine compartment of a running automobile. The alternator is creating a electro-magnetic field, and could cause a temporary woosey feeling.

This is not the same thing as going through with an internal defibrillator type of pacemaker. You shouldn’t take the chance. As in evil Dick ‘Dr. Strangelove’ Cheney should keep flying on the private jets and USAF military aircraft - all at taxpayer expense of course, and avoid any ‘security’ measures. The electro-magnetic suppression of the defibrillator could confuse the internal device into thinking that the heart isn’t beating, and therefore give the wearer an unnecessary ‘jolt’. For Dick this could be a good thing. For normal people, not so much.

Dr. Handsome recommended that Mr. Maven continue with the ‘pat down’ over in the special aisle, but if for some reason it was just the machines or nothing, then quickly go for it, but don’t make a habit out of it. Tell the TSA that you have a pacemaker.

If you have any real questions call the manufacturer of your pacer. The number is on the back of the card you carry in your wallet.

-maven