tibor75

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http://www.theheart.org/article/926729.do

Washington, DC - Sen Charles Grassley (R-IA) has launched an investigation to determine whether Edwards Lifesciences marketed the Myxo-ETlogix mitral-valve ring without first obtaining FDA approval and whether the device was being used without informed patient consent. In letters sent Wednesday to Edwards, Northwestern University, and the FDA, Grassley, the ranking member of the Senate Finance Committee, said he had "recently received troubling allegations that Edwards Lifesciences' Myxo ETlogix 5100 Ring . . . has not been approved and/or cleared for marketing by the Food and Drug Administration."

As previously reported by heartwire, the Myxo ring was invented by Northwestern surgeon Dr Patrick McCarthy. Both McCarthy and Northwestern have been fending off allegations from a patient that McCarthy used the device before it was formally approved and without first telling the patient that he might use it.

Most concerning:

Grassley's letter also asks Northwestern to explain actions taken against Rajamannan and specifically why she was asked to agree, in a letter sent July 24, 2008, "not to provide clinical care at Northwestern Medical Faculty Foundation and Northwestern Memorial Hospital."

Rajamannan has confirmed to heartwire that her clinical practice at Northwestern is "on hold" but that she is still a full faculty member at Northwestern and has continued work on her National Institutes of Health R01 grant work during the period in question.


Also, rumors are rampant that there is a reshuffling of leadership, but can't confirm that for myself as I am peon.
 
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dragonfly99

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This seems more like a CT surgery problem than a problem in the cardiology dept.

The IM dept. there just got a new chairman who is a cardiologist, which at least in theory should be good for the cardiology division...
 
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tibor75

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This seems more like a CT surgery problem than a problem in the cardiology dept.

The IM dept. there just got a new chairman who is a cardiologist, which at least in theory should be good for the cardiology division...
Not really. CT surgery is where the problem started, but it seems that the "whisteblower" was a cardiologist...who ended up suspended from clinical duties. Of course, htere is likely more to the story, but that much is public knowledge.

As per the other poster, yes, I heard that too....that the chief is leaving.
 

dragonfly99

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I don't know a thing about these putative problems @ Northwestern, but if a chief of cardiology is leaving I don't think it necessarily means anything bad is going on. People leave all the time in academics if/when they get a better offer, like a dept. chairmanship, etc.
 

tibor75

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I don't know a thing about these putative problems @ Northwestern, but if a chief of cardiology is leaving I don't think it necessarily means anything bad is going on. People leave all the time in academics if/when they get a better offer, like a dept. chairmanship, etc.
True, of course, but if a chief is leaving at the same time there is a scandal going on involving CT surgery and a cardiologist, then it will and should raise some eyebrows.
 

Mixmaster

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The CV disease fellowship program director is also relatively new. Did the previous director leave?
 

dadr

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The CV disease fellowship program director is also relatively new. Did the previous director leave?
No. Dr. Vera Rigolin is the past fellowship director and is still there--I interviewed with her as well as Drs. Holly (the "new" PD) and Bonow last year. Absolutely outstanding fellowship program which I may have ranked first if not for cost of living. Did you really hear that Dr. Bonow is leaving Northwestern?
 

tibor75

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Did you really hear that Dr. Bonow is leaving Northwestern?
I have heard so from 3 different people, but I'm not "in the know" so I won't pass it along as fact. But if the same rumor is reported by 3 different poeple from 3 different institutions, then.....
 
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