MRI PACER

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Anonymous

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How can we tell our physicians that the current line of pacemakers in the US are the same as the MRI pacemakers in Europe? We were instructed to run with this in our area. Can someone explain to me if they are the same?
 






Anonymous said:
How can we tell our physicians that the current line of pacemakers in the US are the same as the MRI pacemakers in Europe? We were instructed to run with this in our area. Can someone explain to me if they are the same?
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The same...but without FDA Approval it means nothing here in the US. In fact, its technically criminal to "run with it" as you say, since the physician customer could be mislead in to implanting something they think is Conditionally MRI Safe when in fact that is not the case in the US.
 






The previous poster is correct...

It is the same device without FDA labeling for 'MRI Safe' but I would be very careful 'running with that' as it is false marketing. Of course, if you have a relationship with a doc and you can have a candid discussion with them and lay the facts out there as they are, they can put 2+2 together.

My questions are... Does it really matter? Are you going to gain anything by this?
 












keep in mind that CMS will only reimburse for MRI scan for patients with pacemakers when the pacemakers are used according to the FDA-approved labeling for use in the MRI environment.

so if a physician were to implant said OUS MR conditional pacemaker system, conducting an MR scan here in the US would be considered off-label AND non-reimbursable.
 












Anonymous said:
keep in mind that CMS will only reimburse for MRI scan for patients with pacemakers when the pacemakers are used according to the FDA-approved labeling for use in the MRI environment.

so if a physician were to implant said OUS MR conditional pacemaker system, conducting an MR scan here in the US would be considered off-label AND non-reimbursable.
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Wow...this is pulled right from the "No Shit" Column. Most of us have been warning the guy not to even TALK about the damn thing, much less convince someone to implant one.
 






Anonymous said:
Wow...this is pulled right from the "No Shit" Column. Most of us have been warning the guy not to even TALK about the damn thing, much less convince someone to implant one.
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I keep hearing device in these threads. The most significant design change required to make mdt's MRI conditional "system" was lead design. Aside from all the other comments, the leads pose the biggest danger and I assume bio leads will require redesign if they are to ever be considered safe.
 






Anonymous said:
I keep hearing device in these threads. The most significant design change required to make mdt's MRI conditional "system" was lead design. Aside from all the other comments, the leads pose the biggest danger and I assume bio leads will require redesign if they are to ever be considered safe.
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Those bio leads are the savior of the industry......Haven't you heard? They stop speeding bullets, cure HIV, and they even sell them to BSX. An MRI can't stop them.... Even though the FDA should stop this thread and punish them for starting it. Biotronik and the industry is in trouble, they are losing money as well as all...they are still giving huge guarantees to reps for promises.... And I thought they learned their lesson with Bobby Mus and TB not to give those out.
 






Anonymous said:
Those bio leads are the savior of the industry......Haven't you heard? They stop speeding bullets, cure HIV, and they even sell them to BSX. An MRI can't stop them.... Even though the FDA should stop this thread and punish them for starting it. Biotronik and the industry is in trouble, they are losing money as well as all...they are still giving huge guarantees to reps for promises.... And I thought they learned their lesson with Bobby Mus and TB not to give those out.
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I am not sure about speeding bullets, but it is pretty amazing how they remain intact inside the human body. The leads are already MRI Conditional in Europe, so no redesign...just a more powerful FDA Lobbying team.
 






Anonymous said:
I am not sure about speeding bullets, but it is pretty amazing how they remain intact inside the human body. The leads are already MRI Conditional in Europe, so no redesign...just a more powerful FDA Lobbying team.
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. Since we're not talking about tachy STJ leads here, that was a pretty stupid response on your part. Way to stay on task. Keep up the strong work!
 






Anonymous said:
Those bio leads are the savior of the industry......Haven't you heard? They stop speeding bullets, cure HIV, and they even sell them to BSX. An MRI can't stop them.... Even though the FDA should stop this thread and punish them for starting it. Biotronik and the industry is in trouble, they are losing money as well as all...they are still giving huge guarantees to reps for promises.... And I thought they learned their lesson with Bobby Mus and TB not to give those out.
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"Stop this thread and punish them for even starting it" Are you serious? Bio didn't start this thread. Some DB started it to create some banter over their MRI pacemaker. Sort of like MDT taking about their remote programming, right? MDT should be punished for that too I guess.

Go pick up lunch you douche!
 
























Anonymous said:
How can we tell our physicians that the current line of pacemakers in the US are the same as the MRI pacemakers in Europe? We were instructed to run with this in our area. Can someone explain to me if they are the same?
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Yeah, they are the same : 70% exclusion zone from the neck to the waist.

Also, the E.U. trials to date are with 1.5 Tesla MRI scanners, so you also cannot introduce the patient into the newest 3.0 Tesla MRI scanners, which are exponentially stronger.

All future MRI scanners will be higher resolution (much, much higher power ) which knocks out the current limited implantable device approvals in the E.U. Same with MDT, BTW.

MRI creates huge (massive) electromagnetic fields incompatible with existing implanted systems. It will be years B-4 the process is safe for the patient and the doctor`s medical liability.
 






You can say what you want about MRI 'safe' all you want. There are several centers in the SE that will MRI their patients... period. IF they NEED an MRI they do it. All manufacturers all devices. They do their due diligence to perfrom all of the appropriate pre and post testing. They do seem to steer away from pacer dependent patients but all the rest are a go. To this day they claim zero issues. One center claims 100+ MRI's with a mixed bag of devices. They say they hope to publish this info in the next year.

No, I do not have first hand experience of this but it is interesting to hear similar scenarios from different institutions. Has anyone else heard of or seen centers doing the same?
 






Anonymous said:
You can say what you want about MRI 'safe' all you want. There are several centers in the SE that will MRI their patients... period. IF they NEED an MRI they do it. All manufacturers all devices. They do their due diligence to perfrom all of the appropriate pre and post testing. They do seem to steer away from pacer dependent patients but all the rest are a go. To this day they claim zero issues. One center claims 100+ MRI's with a mixed bag of devices. They say they hope to publish this info in the next year.

No, I do not have first hand experience of this but it is interesting to hear similar scenarios from different institutions. Has anyone else heard of or seen centers doing the same?
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Knowing full well what the answer is: Do they get reimbursed for these MRIs?
 






Anonymous said:
Knowing full well what the answer is: Do they get reimbursed for these MRIs?
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Most likely not. I know of an institution that does the same thing. They are a larger academic center so they can get away with a little more. Not all centers are worried about the almighty dollar. They claim around 50 or so MRI's w/devices. They are adamant that they aren't cavalier about it. It is based on the the 'need' for an MRI.

It will be interesting to see if/when any of these alleged scenarios end up on paper.
 






Anonymous said:
Most likely not. I know of an institution that does the same thing. They are a larger academic center so they can get away with a little more. Not all centers are worried about the almighty dollar. They claim around 50 or so MRI's w/devices. They are adamant that they aren't cavalier about it. It is based on the the 'need' for an MRI.

It will be interesting to see if/when any of these alleged scenarios end up on paper.
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They can publish their findings, but the only ones who will make any use of it will be lawyers. As you say, not all centers are worried about the almighty dollar...but most are, and eventhough an MRI is possible...that time is better spent on billable procedures.
 






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