AF Solutions


How do you get FDA approval on anything with a corporate warning letter in place?

Although MDT owns AF Solutions, I believe MDT AF Solutions is considered separate from MDT, hence, the division would exempt from the warning letter. For example, BSC was under a warning letter for some time. During that time BSC CRM (formerly GDT) launched numerous products. Hope that helps.
 

Although MDT owns AF Solutions, I believe MDT AF Solutions is considered separate from MDT, hence, the division would exempt from the warning letter. For example, BSC was under a warning letter for some time. During that time BSC CRM (formerly GDT) launched numerous products. Hope that helps.

MDT is not under a corporate warning letter. Various MDT divisions have warning letters.
 
Can one of the AF Division sales reps comment on how absolutely bored you are sitting around in you PJs all day taking tests and wondering if the Cryo-balloon will ever be approved by the FDA. Has to be de-motivating for those go-get-em sales reps who signed on to this division. I guess I would be a little concerned if this thing doesn't get approved by Q2 2011.
 
Once again arrogant loud-mouthed MDT people think they are going to save the universe! You are way late to this game, don't act as if you are the friggin' mesiah! I left MDT for SJM 7 years ago due to arrogance of MDT, you bastards are losing share daily!!
 
http://www.theheart.org/article/1166735.do

FDA approves first cryoballoon to treat AF
December 20, 2010 | Reed Miller

Minneapolis -The Arctic Front system (Medtronic, Minneapolis, MN) is the first cryoablation balloon catheter available in the US after the FDA approved the technology for the treatment of drug-refractory paroxysmal atrial fibrillation late last week [1].

What time is it? Game time.
 
Cryo and pvac will dominate the paf market.

There is no ep that will do a 4 hr point by point case after tasting this stuff.

3 cases with pvac vs. 1 with stj .


Take a bus trip to canada and see yourself.. Or go to Europe and take a vacation.
 
If you think a skilled EP is spending 4hrs isolating veins for PAF, then you obviously haven't been in the lab lately. Good ones can complete the procedure in 2.5hrs.

That said, the balloon should do well at the outset and it will be interesting to see how JNJ and SJM respond to the "no mapping, no steerable sheath, no irrigated RF" drum MDT plans on beating.
 
You hit it on the head. It is dead in the water.

You don't need me to tell you this today, but clearly your a r*****....PASSSSSED. Now to market it and introduce it to the EP's slowly as a "tool" to aide them in their ablation....and then phase out Radio Frequency all together (for the most part, it will never be completely abolished, some cases won't convert with the Cryo)
 


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