Question-and-Answer Session
Operator
Your first question comes from the line of Greg Simpson with Stifel Nicolaus. Please proceed.
Greg Simpson - Stifel Nicolaus & Company, Inc.
Yes, good morning. Impressive quarter all the way around and certainly for a company that’s been fairly tight with information, I mean there was a lot of information given out today, so I appreciate that as well. First of all Dan, if I could, let’s dig into the quarter first, there is a lot of ground to cover here, but can you maybe help give us a little more detail with the iPulse approval coming very late in the quarter; can you give us some sense as to whether there were iPulse shipments, or some degree of color on that front and the same thing, I guess, in tandem with that, any balloons shipped in the quarter?
Daniel Sutherby
Sure Greg. We did receive the approval, as you mentioned, late December ’07. It is CE marked in Europe, as you probably know, so we actually shipped a hand full of units outside the US during the quarter. For the balloons, we did start shipping balloons, actually at a modest level, in our fiscal Q4 ’07 and continued to ship just north of 200 in fiscal Q3 of ’08.
Greg Simpson - Stifel Nicolaus & Company, Inc.
Okay, but any iPulse shipments in the US, in Q3?
Daniel Sutherby
We have some folks that are getting it, but we’re unable to get them trained and ship it and collect revenue for the quarter.
Greg Simpson - Stifel Nicolaus & Company, Inc.
Okay, thanks. That answered the question. Secondly, for either Mike or Karim, on the Impella 2.5 and the required bench testing to satisfy the FDA, any elaboration there, not specifically what they’re looking for, but any elaboration as to how detailed that might be?
Michael Minogue
You know, bench testing, historically, is looking at some of the reliability. We have actual clinical data, but they wanted us to do a bench test as compared to one of the predicate devices; and as we stated in the 8(K), none of the predicate devices had actual patient clinical data. That’s more an apples to apples.
Greg Simpson - Stifel Nicolaus & Company, Inc.
Right, okay thank you. And then, on the Impella AMI study, a lot of detail there on the potential for the number of patients and the number of centers; I’m curious, Mike, if you could give us some sense of how much overlap do you expect between a high risk PCI pivotal and the AMI trial in terms of centers?
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