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.



'Is Eat Real Food' Unthinkable?

Like a Greek friend of mine always said, “I said it, and I heard it”. And, I’ve been saying it for so long that it’ ingrained in my brow - the argument, the ‘debate’ about what to eat is such a no-brainer. Like Michael Pollan said: “Eat food. Not too much. Mostly plants.”

But true to form, the FDA, in their newly released guidelines, is making it so complicated that the average American consumer will throw up their hands in despair and head off to McDonald’s. That’s what our government agencies do these days in order to please their corporate masters, and those on the right that deeply believe that all government regulation of industry is bad, bad and even more bad.

The FDA has once again buried any good parts of their message - for Americans to eat more real, unadulterated, whole foods that they prepare at home - in so much mumbo-jumbo that big agri-business won’t get upset and come a-knockin’.

Mark Bittman weighs in eloquently.

- maven

By New York Times food writer, Mark Bittman

In recent weeks we’ve seen a big, powerful government agency, a big, powerful person and a big, powerful corporation telling us what to eat. Even with all this big, powerful input, we know nothing that we didn’t know last year. We do, however, have a new acronym; unfortunately, it’s not the one we need.

And a little progress. Limited kudos go to the United States Department of Agriculture, whose Dietary Guidelines for Americans, 2010 — yes, it’s 2011, but they’re published every five years — are the best to date. We’re told to eat “less food” and more fresh foods; wise advice. But aside from salt, the agency buries mostly vague recommendations about what we should be eating less of: we’re admonished to drink “few or no” sodas — hooray for that — and “refined grains,” Solid Fats and Added Sugars. And there’s our fabulous acronym: SOFAS.

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Getting the most out of the Nutrition Facts labels

I see people in the grocery stores struggle to make real sense out of the Nutrition Facts labelling on food products - particularly seniors.

Here’s a great pdf booklet, provided by the U. S. Food and Drug Administration, that you can print out and give to the seniors in your circle.

Click on the image, to redirect to the FDA site.

Avastin pulled: No real benefit for breast cancer patients

GAITHERSBURG, Maryland (Reuters) - A U.S. panel urged officials to revoke the drug Avastin’s approval for breast cancer after concluding studies showed insufficient benefit for patients.

If regulators follow that advice, the drug’s maker, Roche, could no longer promote Avastin (bevacizumab) for that use in the United States.

Doctors still could prescribe Avastin for breast cancer as it would retain approval for colon, lung, brain and kidney cancers, but sales likely would fall.

Members of a Food and Drug Administration panel said they were not convinced Avastin provided worthwhile benefits in advanced breast cancer. The drug did not extend patients’ lives but delayed cancer growth by up to three months.

Click here to read the rest of the article ….

Is your food making you sick?

I saw this on this morning’s Today Show and, in my opinion, this woman- Robyn O’Brien - is spot on right. For the last several years, partly as a response to my cancer diagnosis, I really got paying attention to my food and the additives that are found throughout the American food supply.

It’s really appalling, and unnecessary. It’s also contributing to an epidemic of food allergies among children.

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Irrational fear of irradiation making us sick

Each and every time I read about the next big food borne illness that sweeps this country, I get annoyed about two things. First, the lax inspection standards and gutted regulatory structure, thanks to the Bush administration ( and the other preceeding administrations - W. can’t hog all the blame ). Second, that so much of this is preventable by simple means of irradition.

Note that I didn’t say radiation.

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