BIO Ilesto ICD with non-MR conditional lead

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Anonymous

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Just heard of a case where an Ilesto DR was paired with a non-MR conditional lead. Patient is not happy. Pt. has MS and needs yearly scans. Doc is now blaming the rep for handing him a non-MR conditional BIO lead at the time of implant. Who's at fault here?
 












Well sounds like he handed him a non MRI conditional can as well... the Ilesto has been out for awhile... just like the Evia pacer. The Evia is not proMRI nor is the Ilesto. The proMRI cans are Entovis and Iforia.
 












Complete BS…. There is no vendor with an FDA approved MRI safe ICD lead or can in the United States. IF this story is true then the physician has to be a complete moron not to understand that.

Keep trolling jackass.
 






Anonymous said:
Just heard of a case where an Ilesto DR was paired with a non-MR conditional lead. Patient is not happy. Pt. has MS and needs yearly scans. Doc is now blaming the rep for handing him a non-MR conditional BIO lead at the time of implant. Who's at fault here?
Click to expand...

Dear Troll,

Actually, the entire system that was handed off was 'non-MR conditional'. Assuming that you meant MRI conditional then the previous poster is correct in that the physician must be a complete moron not to know that there is NOT an approved MRI conditional/safe ICD lead and/or can in the US. To be blaming BIO or the BIO rep on this is bush league. My guess is that your story is complete bullshit. If these are your tactics then you might need to find another job. No wait, I hope you keep your job AND I hope that you are in my area and no Im not a BIO rep but even they could kick your ass.
 






Anonymous said:
Just heard of a case where an Ilesto DR was paired with a non-MR conditional lead. Patient is not happy. Pt. has MS and needs yearly scans. Doc is now blaming the rep for handing him a non-MR conditional BIO lead at the time of implant. Who's at fault here?
Click to expand...

The doc for failing to know that NO company, as of today, has an FDA approved MRI safe/conditional ICD product.
 






Anonymous said:
Dear Troll,

Actually, the entire system that was handed off was 'non-MR conditional'. Assuming that you meant MRI conditional then the previous poster is correct in that the physician must be a complete moron not to know that there is NOT an approved MRI conditional/safe ICD lead and/or can in the US. To be blaming BIO or the BIO rep on this is bush league. My guess is that your story is complete bullshit. If these are your tactics then you might need to find another job. No wait, I hope you keep your job AND I hope that you are in my area and no Im not a BIO rep but even they could kick your ass.
Click to expand...

Bio reps in my area have pushed this as being the same can approved in Europe. So basically pre selling. Docs didn't buy it but don't be surprised if other reps are pulling the same tactic.
 






Anonymous said:
Bio reps in my area have pushed this as being the same can approved in Europe. So basically pre selling. Docs didn't buy it but don't be surprised if other reps are pulling the same tactic.
Click to expand...

It's no secret that their entire bag has been MRI safe in Europe for some time now. Pre-selling did them no good once the name change occurred for their MRI devices and the company decided to not make their Evia, Lumax and Ilesto lines non-MRI. Whether or not the docs bought into doesn't really matter. It is up to the radiologist to scan or not scan a non-MRI approved system.

Personally, I'm not going to throw stones at them for pre-selling if some reps did so. If I had CE marked devices for MRI in my bag I would not hide the fact they were were MRI safe in Europe and most of you out there would not either as long as you are very clear that they are NOT FDA approved for MRI here in the States no harm done.
 


















Anonymous said:
Soooo? It's illegal
Click to expand...

it is not illegal to answer a question….

Doc: is this product MRI approved? Rep: No, it is not FDA approved as MRI safe. Doc: I thought it was MRI safe? Rep: No, in the United States it is not FDA approved for MRI scans. It is CE approved for MRI in Europe but again, it is not FDA approved in the United States.

That is not illegal.
 


















Anonymous said:
Get off your high horse...EVERYONE talks about what is coming down the pipe… LV quad leads, Watchman, sub-Q, MRI (all companies), Rhythmia, etc.
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People get on CP to be high and mighty especially MDT reps because they have never talked to a physician about their upcoming MRI ICD system, Linq, 'implantable pacemaker', I-Pad programmer, etc. They have never paid docs to participate in clinical studies. They have never paid docs to participate in advisory boards, expert panels, etc. They have never paid docs to speak for them. They have never taken docs to Puerto Rico just to visit the lead factory… no golf, no rum tours… just a visit to the factory and back to the airport. They have never held extravagant AHP meetings at The Ritz-Carlton. Nope… not MDT they don't do any of that. Just the other guys.

Actually, is what they DON'T talk about is how they are going to screw their docs over by nickel and dining them to death with fees for service and remote monitoring.
 






Anonymous said:
Get off your high horse...EVERYONE talks about what is coming down the pipe… LV quad leads, Watchman, sub-Q, MRI (all companies), Rhythmia, etc.
Click to expand...

No not everyone. When you left the big three we got a little better. You're at Biotronik counting down to retirement. The industry as a whole will be better when that happens.
 


















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