Question-and-Answer Session
Operator
Thank you. Ladies and gentlemen, we'll now be conducting the question-and-answer session. [Operator instructions]. Our first question is coming from Paul Choi with Merrill Lynch. Please state your question.
Paul Choi - Merrill Lynch
Hi, thank you, good afternoon. Could you Mike, please give us a little more color on the sort of data that the FDA is requesting with respect for the Magna mitral and your expectations for a time of delivery of those particular responses to their question.
Michael A. Mussallem - Chairman and Chief Executive Officer
Yes, thanks Paul. Yes we were... we are a little surprised by this Paul. Recall, this is a PMA supplement and what they've asked us for actually is some more detail and some more analysis around bench testing that's been associated with this valve and so we are going through that right now and we expect to respond to them shortly. But frankly, its... it had surprised us and so this is why we are showing uncertainty and exactly when we are going to be able to get this approval. So although I would like to be able to really pin it down to a more precise date, we just don't know right now, Paul.
Paul Choi - Merrill Lynch
So, it's more... there is no safety data request, just performance that you can do in-house, correct?
Michael A. Mussallem - Chairman and Chief Executive Officer
Yes, you know the... this platform is really built off the very same platform that's out there in our Magna valve which is the market leading valve and has an incredible profile in terms of safety and performance, but what FDA has asked us for is beyond what they have asked us for historically and so that's why we have not anticipated this and so we are generating additional data and again it... it's bench testing and analysis that supports that.
Paul Choi - Merrill Lynch
Okay. Thank you very much, I will jump back in queue.
Michael A. Mussallem - Chairman and Chief Executive Officer
Thanks.
Operator
Thank you. Our next question is coming from Larry Biegelsen with Wachovia Securities. Please place your question.
Larry Biegelsen - Wachovia Securities
Hi, thanks for taking my call. Can everybody hear me okay?
Michael A. Mussallem - Chairman and Chief Executive Officer
Yes, I can hear you great, Larry.
Thomas M. Abate - Corporate Vice President, Chief Financial Officer and Treasurer
Hi Larry.
Larry Biegelsen - Wachovia Securities
Mike, last call you said that you would expect double-digit EPS growth in 2008. Is that still intact and can you be more specific on what you meant by double-digit growth and also how dilutive will the Japanese deal be?
Michael A. Mussallem - Chairman and Chief Executive Officer
Yes, thanks Larry. I am not going to give you a real satisfying answer here, what we do is, we go through a very detailed process that's actually going to be completed at the end of this month and the first of next month, when we go through and make all our trade-offs for 2008. And following that, we will have some very detailed guidance that we'll be able to provide when we come to you and see you at the investor conference in early December. What I said on the last call is we have an internal goal, we would like to get this to double-digits, we would like to get this to 10% for next year, but we really need to work through the trade-offs and make sure that its in the best interest of the business and shareholders to run it that way.
In terms of this particular transaction, as I mentioned, its $27 million worth of annual sales and so when that goes away, the gross profit contribution associated with that also goes away. That's in the... say in the $10 million neighborhood. Now, we have a couple of choices in terms of the way we run that. We can... this is sold by the same sales force that sells our Critical Care products in Japan. So we can either reduce that expense or we can redeploy the sales force to sell more of our new exciting Critical Care products like FloTrac and PreSep and it's probably going to be a balance of both. And so the reason that we said that there will be some moderate dilution in '08 is we are anticipating that we're going to do some redirecting of that sales force, which means that we... while they are ramping up here, we won't get the full benefit of their efforts. But we expect to get the full benefits to that and that will turn out to be a good deal for people from 2009.
Larry Biegelsen - Wachovia Securities
And percutaneous valves or transcatheter valves in the fourth quarter, should we expect any sales at all in Europe in 4Q 'O7 and if so, can you give us a little bit of sense of what that looks like?
Michael A. Mussallem - Chairman and Chief Executive Officer
Well thanks, Larry; and again we're going to have to let the others ask questions as well. But in the fourth quarter, we've already begun sales for transcatheter valves, but as we said before, we expect these to be really insignificant, pretty modest in the fourth quarter, while we are ramping up. So if we do get better sales there sort of it will be an upside to what we are projecting, its not really in our numbers for Q4.
Larry Biegelsen - Wachovia Securities
Thanks, I'll get back in the queue.
Operator
Our next question is coming from the Glenn Novarro with Banc of America Securities. Please state your question.
Glenn Novarro - Banc of America Securities
Hi, yes. Two questions; first, it really sounds like Magna mitral won't be approved here in the fourth quarter. So just to clarify, are you more comfortable therefore at $0.62 in terms of EPS and $275 million in revenues, is question one. And then, can you remind us, the PARTNER trail, just to clarify, when do you now expect that trial to officially end enrollment? Thanks.
Michael A. Mussallem - Chairman and Chief Executive Officer
Okay, Yes, Glenn, I'll start out here and Tom can add to this. Yes, what we said about mitral Magna is, if it doesn't show up in the fourth quarter and again maybe for being conservative, we should have assumed that say it doesn't happen, we give $0.52 to $0.54 range and we said, we'll be at the low end of sales and profit. So you interpreted that correctly Glenn to say, yes, closer to the $0.52 on profit; yes, closer to $2.75. Obviously there is many other variables, but that's sort a bit on a high level. Tom, do you have any thing to add to that?
Thomas M. Abate - Corporate Vice President, Chief Financial Officer and Treasurer
No, that covers it, Mike.
Michael A. Mussallem - Chairman and Chief Executive Officer
And the... PARTNER trial, again what was your question specifically about?
Glenn Novarro - Banc of America Securities
Like you to add, can you... because you said, there is a little bit delay in terms of enrollment --
Michael A. Mussallem - Chairman and Chief Executive Officer
Yes.
Glenn Novarro - Banc of America Securities
And then on the call that it looks like its going to be closer to 18 months in terms of enrollment. So I just wondered if you can just clarify to us, exactly you know, it is early '09, specific in terms of when you expect to enroll?
Michael A. Mussallem - Chairman and Chief Executive Officer
No, we are still about... thanks very much for that Glenn. No, we are still talking about 2008 there. Then just to give you a little bit more color there's two specific reasons that probably heard us here, that we said... remember, we started this trial at the end of Q1 of last... of this year and so we are talking about... that was the guidance we gave at that time that would take us 12 to 18 months to enroll from there. The reason that we've gone slower than we would have liked is one, we have added a tougher time getting centers up. It's a combination of... it took a little longer to get through the IRBs. These were just the fairly complex protocol for them, they have proven. And also FDA has plugged themselves in the process and probably added an extra 30 based on top of it that we hadn't anticipated. And though that's over at this point, we don't think that the FDA is going to do that any longer and we do expect to have 15 sites off then hopefully enrolling here before the end of the year. But the other thing that's happened Glenn is, because we don't have transapical in the trial, it takes a group of patients out of that and again we're working hard to get transapical added into the trial but that also slows things down a little bit.
Glenn Novarro - Banc of America Securities
Just one more... one last follow-up on Magna mitral. Is there... lets say the FDA approves this December 15th. In your booked revenues, the last two weeks, can you ship product or post a certainty in December, its best just to launch it in January.
Michael A. Mussallem - Chairman and Chief Executive Officer
Yes, in general there Glenn, I think you should anticipate that we would have sales up, if we got it in the 15th of December, but this isn't one of those product lines where you would do a lot of stacking of shelves and get a whole quarter's worth of sales on the last two weeks. So I wouldn't look it at that way, I would look at it more, little bit more, sort of measured across the quarter.
Glenn Novarro - Banc of America Securities
Okay, Thanks for the clarity. Thanks Mike.
Operator
Our next question is coming from Tim Nelson with Piper Jaffray. Please state your question.
Tim Nelson - Piper Jaffray
I just... on the PARTNER's trial, if you will. If you got the Ascendra approved, how fast could you... how much of that is enrollment?
Michael A. Mussallem - Chairman and Chief Executive Officer
You know this could have a... we think it could have a substantial difference. Of course it's a little bit of speculation, Jim, but when we think about people that now they don't get into the trial. One of the key reasons why they don't get into the trial is access reasons and so the transapical, the Asendra delivery system makes a difference. And so, it certainly steps up the rate substantially from where we would be today. So I don't know how to put that exactly in time. It depends on when we get it, but I think enrollment would be substantially faster.
Tim Nelson - Piper Jaffray
What are the issues with the FDA in allowing you to include that material and what you need to do?
Michael A. Mussallem - Chairman and Chief Executive Officer
There... one of the things they'd like to do is they have all the data be poolable, Tim and so they're going through and analyzing our results as it relates to transapical and they also want to make sure the trial is very statistically sound. And so these are things that influence and then... we're talking through two different options in terms of how it might be able to add it to the trial. We're confident we're going to be able to ultimately do it. But we're trying to end up with the trial that's really good for patients and also going to have a favorable outcome.
Tim Nelson - Piper Jaffray
But one way or the other, would you take a decision on that in this quarter?
Michael A. Mussallem - Chairman and Chief Executive Officer
I'd like to think so. Our goal is to certainly have a decision this quarter, but it's possible that it could drag out. If they agree with us, we'll have a decision this quarter but we're... this is kind of a top priority for us Tim.
Tim Nelson - Piper Jaffray
On license, can you give us a little better feel for when that final approval might come. What that delay is about and when in '08 you may?
Michael A. Mussallem - Chairman and Chief Executive Officer
Okay thanks Tim. And we're going to have to make sure that we get everybody a chance to ask questions. Right now, we would say that we expect to have our LifeStent response in by November and so it would restart the clock. So if everything went just great, we will have an approval in the first quarter; if we get additional questions, it will go beyond that, but right now we are hopeful that it's more near term.
Tim Nelson - Piper Jaffray
Thanks.
Operator
Our next question is coming from Glenn Reicin with Morgan Stanley. Please state your question.
Glenn Reicin - Morgan Stanley
Hi, can you hear me?
Michael A. Mussallem - Chairman and Chief Executive Officer
Yes,hear you great, go ahead.
Glenn Reicin - Morgan Stanley
Okay, two questions. If in fact LifeStent, the approval doesn't come in the first quarter but it comes later. Is that actually material to 2008 sales and which is that label really make a difference at the end of the day? And then on the transapical delay, are you absolutely certain that it will be part of the PARTNER's trial and what are the prospects for you doing just the whole separate approval track for that approach?
Michael A. Mussallem - Chairman and Chief Executive Officer
Okay. Yes, let's try and work through those, Glenn. So, your first question is, if we didn't get it in Q1, will that be material to us? I would say, the ability to promote is certainly a positive, when we say, that's a big positive. You know we have not given guidance for 2008, so it's probably little tough to talk about materiality, but the other thing that goes along with that is our sales force. And because we haven't made decisions yet on ramping up sales force, that's an additional factor and we are probably going to tie our sales force addition to the approval, Glenn and those will go together. In terms of the transapical delay and will we be able to add up to the PARTNER trial; if you were to ask us internally, we do believe that we are going to be able to add up to the PARTNER trial. We don't think that there is any philosophical or fundamental issue that's going to keep it out of that. But you know we are still also considering the option of a separate trial and that's something we will consider in addition to adding to the PARTNER trial and we're working through that whole internal decision process ourselves.
Glenn Reicin - Morgan Stanley
And what's the give and take, I know... how does that really affect, whether it's a separate trial or PARTNER?
Michael A. Mussallem - Chairman and Chief Executive Officer
Well I guess it's just its additional patient experience. It allows more surgeons to get involved with the transapical procedure, which we... there is a tremendous amount of demand out there for them to be able to do exactly that.
Glenn Reicin - Morgan Stanley
Okay. I'll get back in line.
Operator
Our next question is coming from Michael Weinstein with J.P. Morgan. Please state your question.
Chris Pasquale - J.P. Morgan Chase & Co.
Hi, this is Chris Pasquale here for Mike.
Michael A. Mussallem - Chairman and Chief Executive Officer
Hey Chris.
Chris Pasquale - J.P. Morgan Chase & Co.
Couple of topics. First, the valve repair growth has been down in the mid single-digit range now for about three quarters. And this was a segment that had been growing I think low double-digits prior to that. Is this an inflection point in the market growth, or you guys loosing share, can you help us understand what's happening there and whether we should model it like this, going forward?
Michael A. Mussallem - Chairman and Chief Executive Officer
Yes. I think your observation is correct. It has been growing more slowly, recently. What we have is that most of our growth here is coming in our premium products, our more indication specific product. And we've had increased competition in the products that are more matured. And so I don't think it's a change in the market growth rate. I do think that we have had some share loss in the more matured product.
Chris Pasquale - J.P. Morgan Chase & Co.
Is there something that's likely to change in the near future or...
Michael A. Mussallem - Chairman and Chief Executive Officer
Well, we constantly are going to keep working on that. But clearly, the competitors, I think are focused on being able to get into this repair marketplace and I think that although repair will continue to grow, that will probably be a more competitive segment.
Chris Pasquale - J.P. Morgan Chase & Co.
And then on PARTNER, I don't think you mentioned how many centers were possible for the interim in the quarter, can you just update us on how many centers --
Michael A. Mussallem - Chairman and Chief Executive Officer
I am sorry. Can you clarify that question?
Chris Pasquale - J.P. Morgan Chase & Co.
How many centers are up and running right now and actually enrolling patients in the trial as of 15th?
Michael A. Mussallem - Chairman and Chief Executive Officer
You know, I don't want to... I am guessing right now that we have six centers up in PARTNER right now that are actually up there. They are certainly more than that trained, you know what, I am not certain of Chris is the difference between the trained numbers and the enrolling numbers.
Chris Pasquale - J.P. Morgan Chase & Co.
Right.
Michael A. Mussallem - Chairman and Chief Executive Officer
I think we are in the 5-6 range on the enrolling, but the trained numbers is... may be twice that.
Chris Pasquale - J.P. Morgan Chase & Co.
Okay, thanks.
Michael A. Mussallem - Chairman and Chief Executive Officer
Yes.
Operator
Our next question is coming from Tim Lee with Caris & Company. Please state your question.
Tim Lee - Caris & Company
Hey, good afternoon. Just two quick questions here; first, from a housekeeping standpoint, can you give us the numbers for FloTrac and LifeStent and then just on that kind of same vein, looking at fourth quarter then what should we kind of think of the contribution from discontinued products are? Hope we're trying to get what your organic growth could be in the fourth quarter? Thank you.
Michael A. Mussallem - Chairman and Chief Executive Officer
Let me take a shot at it. FloTrac and LifeStent Tim, we're trying to stay out of reporting quarterly numbers on those product lines, around both those product lines what we indicated at the start of the year as we expected those, their sales to double in 2007 versus what they did in 2006, and we are right on track to do that. I think if you looked at the growth rates in Critical Care and in the Vascular product line, you'll see that they're driven by these new products and so they are growing nicely. We get back into it and maybe our guys can give some additional color here, if you want to talk to him after the call. Tom, can you get back to --
Thomas M. Abate - Corporate Vice President, Chief Financial Officer and Treasurer
You may have here on Tim. Fourth quarter, you are looking for specific things.
Michael A. Mussallem - Chairman and Chief Executive Officer
You want a full year or run rate or what would be ideal, Tim?
Tim Lee - Caris & Company
All the above. How's that?
Michael A. Mussallem - Chairman and Chief Executive Officer
Well, let me talk about what it is --
Tim Lee - Caris & Company
No, or... its fourth quarter is fine, I mean whatever these are?
Thomas M. Abate - Corporate Vice President, Chief Financial Officer and Treasurer
Well, you know third quarter we've got $10 million and nine months to-date it's about $31 million, $32 million and that should be... I don't have this full year number in front of me, but it should probably drop down. I want to say something around in the neighborhood, 6 or 7 in the fourth quarter, but you can double check on that detail.
Michael A. Mussallem - Chairman and Chief Executive Officer
But again it will pop up again starting in 2008 as we discontinue our distributed business in Japan.
Thomas M. Abate - Corporate Vice President, Chief Financial Officer and Treasurer
That will start over the next year, that's correct.
Tim Lee - Caris & Company
Thank you.
Operator
Our next question is coming from Amit Bhalla with Citigroup. Please state your question.
Amit Bhalla - Citigroup
Hi. Thanks for taking the question. First question, you mentioned you are designing a new valve for the transcatheter program. As you move to smaller valve sizes, do you need to move to a self-expanding stent platform?
Michael A. Mussallem - Chairman and Chief Executive Officer
You know what, we've not spoken to that particular, but the short answer is almost no, that's not a self-expanding platform, we're able apply technology to our balloon expandable platform and be able to do that. What we're excited about is that we're going to be able to take substantial size out of this system maybe four French sizes out of this which will make it far more deliverable and applicable to more patients.
Amit Bhalla - Citigroup
So what does that get you down to?
Michael A. Mussallem - Chairman and Chief Executive Officer
Well, you know there what happens is always difficult for us to throw out a specific number because in our case, we have various valve sizes. Recall, we have a 23millimeter, a 26 millimeter, we're going to have a 29 millimeter valve and each of those will have slightly different delivery dimensions. So, we'll have some that are below 20 French, but we might actually have some that are... I don't know 21 French. So, it sort of... it depends on valve size, but usually in the good news is that you need a big valve usually your anatomy feel bigger too.
Amit Bhalla - Citigroup
Okay. And just second question here, there's been some discussion at TCT about pacemakers being implanted in the older patients post transcatheter valve procedures. Can you comment on that? What kind of experience you are seeing in your patients?
Michael A. Mussallem - Chairman and Chief Executive Officer
Yes I think... if I remember correct what John Webb reported recently and maybe also was repeated out of Colombia was a pacemaker implantation and what I want to say was in the maybe the 3% 4% rate and as far as I understand the competitive valve had one... its may be 10 times that rate or running much higher and I can't explain exactly why that is, but it appears that there is a difference at this point in time although we will say that the data is still early for both valves.
Amit Bhalla - Citigroup
But is that due to a geographic difference or is there a products difference?
Michael A. Mussallem - Chairman and Chief Executive Officer
You know I would be speculating at this point. I think it's probably best to talk to clinicians about what they think the difference might be.
Amit Bhalla - Citigroup
Okay, thanks for the questions.
Michael A. Mussallem - Chairman and Chief Executive Officer
: Sure.
Operator
Our next question is coming from Kristen Stewart [ph] with Credit Suisse. Please state your question.
Unidentified Analyst
Hi. I was just wondering if you could comment a little bit more on the patents... the Andersen patterns that you have now for ownership of? Did you have to pay anything to support them or pay anything to J&J for them to give up their licensing rights?
Michael A. Mussallem - Chairman and Chief Executive Officer
Yes, thanks for the question. I know this may be sounds a little bit confusing to the audience because this was one that we already had exclusive license to, but all we've done is to step this up to full ownership and actually there was a financial transaction both with Dr. Andersen and also with Johnson & Johnson, although we are not disclosing the terms of that and then is not really material for Edwards, is pretty nominal sort of terms. But what it does is it puts us in the position to have greater overall control of the prosecution and the enforcement of these which is important, and you know we are already in an enforcement action in Europe and so we wanted to have maximum control as we are going through that process which we would expect to be tested overtime.
Unidentified Analyst
Are there any other payments that are required going out?
Michael A. Mussallem - Chairman and Chief Executive Officer
You know, for the most part, this clears it all up, there is a little bit that we will be going across and that's really nominal, its really not material to us and so really is pretty much all in at this point.
Unidentified Analyst
areas, they are increasingly more conservative you're seeing it with the Magna valve and your SFX right now. How do think by going forward just in terms of as you look to further develop the transcatheter program that's bringing in additional sizes, bringing it below a 20 French, is that something that you may consider doing to hold up your existing trial to get that in or is that something where you'd have to start a whole new trial down the road only you have several years to bring that forward to the market?
Michael A. Mussallem - Chairman and Chief Executive Officer
Well, a couple of things; one is, we know that FDA is working hard to make sure that they protect the public and so they are... I think they're pushing everybody to make sure that we do a great job with the products that we bring to market and we feel like we know more about heart valves than most people and we are pretty expert at this. So we still have struggled to be able to predict our approval times and so we are a sort of taking up our level of effort and our commitment to try and deliver even more than we have in the past and we know that the burden of proof is probably just higher today than it has been in the past. In terms of going forward, I hate to generalize on things. When we go to our next generation valve, we are anticipating that, that will be a new approval process with a new clinical trial. I think when we had changes to delivery systems for the most part, we expect that to be supplements, but it depends on the nature of the change of course, but we've sort of thought this through in terms of what's going to happen next if there is more specificity we are open to the questions.
Unidentified Analyst
So 20 French system wouldn't be more of a supplement type of process?
Michael A. Mussallem - Chairman and Chief Executive Officer
No, its all this specifically, if we talk about our next generation system, we would expect this to be a... we should... we think of it as a new approval process. It's not clear exactly how that will go, but what we are expecting here is that we'll have a new approval process that we'll work through. Although, I would also tell you I don't think that next time through the approval process will be as long as the first time for us.
Unidentified Analyst
: Okay. Thank you.
Operator
Our next question is coming from Alex Arrow with Lazard Capital Market, please state your question.
Alex Arrow - Lazard Capital Markets
Thanks. Could you tell us how your inventory is situated for SAPIEN for your European launch, now that you're launched there, should we assume that you got enough SAPIEN to meet whatever demand there is in Europe or is there a supply issue to consider?
Michael A. Mussallem - Chairman and Chief Executive Officer
We... you may have noticed our... actually our inventory numbers stepped up a little bit this quarter versus last. We built an inventory, it's in place. We feel like we've --.
Thomas M. Abate - Corporate Vice President, Chief Financial Officer and Treasurer
Definitely one of the reasons for the increases in inventory along with Magna mitral.
Michael A. Mussallem - Chairman and Chief Executive Officer
So we feel like we have the inventory in place to be able to support the launch and don't expect that to be a constraining factor.
Alex Arrow - Lazard Capital Markets
Good. Would you be willing to be quantitative in... how many valves you have ready?
Michael A. Mussallem - Chairman and Chief Executive Officer
No, probably not. But, I would say we built a couple of million dollars worth of inventory.
Alex Arrow - Lazard Capital Markets
Okay. And can you say how long, is it a fair question, that's how long it takes to make a SAPIEN valve?
Michael A. Mussallem - Chairman and Chief Executive Officer
You know we are not finding making this valve as grossly different than making one of our traditional heart valves. Since all this is a... it's a process and we have actually people that would make the surgical heart valves. Those are the same people have been trained to be able to make this and there is not a big difference Alex between the time and effort. The costs are little higher now, but it's pretty straight forward and we expect here with a little bit of volume that it will be very similar in terms of manufacturing capability and output.
Alex Arrow - Lazard Capital Markets
Okay thanks. And I apologize, I jumped on the call late, did you give updates on the enrollment status of the U.S. PARTNER trial, if so I can just go back and get it?
Michael A. Mussallem - Chairman and Chief Executive Officer
We did. I don't know if we... we said it specifically but in the prepared comments we said more then 60 patients at this point and we expect to have 15 sites that will be trained and hopefully enrolled in by the end of the year in the U.S.
Alex Arrow - Lazard Capital Markets
Can you say how many sites have enrolled so far?
Michael A. Mussallem - Chairman and Chief Executive Officer
We said that it is in 5-6 range.
Alex Arrow - Lazard Capital Markets
Great, thanks Mike.
Michael A. Mussallem - Chairman and Chief Executive Officer
Okay.
Operator
Our next question comes from Ashim Anand with Natexis Bleichroeder. Please state your question.
Ashim Anand - Natexis Bleichroeder
Thanks for taking my call. Two questions, one is, you said you gained market share in heart valve, so if you can comment on from where did you gain that? And second is basically regarding distributor products in terms of corporate strategy; if you can comment, it looks like you are moving away from distributed product and focusing on critical care and this is resulting into a dilution whereas we see that Critical Care actually provides higher gross margins. And also we see that you have an increase in investments from unconsolidated affiliates. Is this regarding this transaction?
Michael A. Mussallem - Chairman and Chief Executive Officer
Okay, let me try to work to him. The first question related to market share, could you say that again please.
Ashim Anand - Natexis Bleichroeder
So, you said that you gained market share in heart valves, so if you could comment from where you would have... which firm you would have gained the market share?
Michael A. Mussallem - Chairman and Chief Executive Officer
Yes, most of the... I don't know exactly where it came from in terms of what firms we gained from. But this would have been primarily international growth, that's where we saw specially saw in Europe and in... what we call Intercontinental, which is Asia and Latin America. So that's where the growth in particular came within heart valves. In terms of distributed products and that is the strategy, we don't have very many distributed products, we used to do much more of that in the past, but as we have sharpened our focus on the products that we manufacture, meaning those ones that are in particularly that are proprietary products with leadership position. It's a much better use of our people's time to be able to offer those to physician and so by discontinuing... focusing on the distributed products and focus on our proprietary ultimately this is going to be very good for not only our customers from the technology point of view, but also for our profitability and our growth. And although there maybe some short-term dilution, we don't think that's going to last very long and we think its going to be accretive, as they focus on our new products in Japan, and I am still not sure that I followed the last question as you did, Tom.
Ashim Anand - Natexis Bleichroeder
Investments in unconsolidated affiliates has gone up. I was wondering if this was related to this Japan transaction?
Thomas M. Abate - Corporate Vice President, Chief Financial Officer and Treasurer
No, actually it's related to the investments we need to carry on the balance sheet, have to be marked mark-to-market and as a result the Sangamo's appreciation, that's primarily the lion share of that change.
Ashim Anand - Natexis Bleichroeder
Okay.
Michael A. Mussallem - Chairman and Chief Executive Officer
Yes, remember we own quite a bit of Sangamo stocks as a result of the most recent transaction.
Ashim Anand - Natexis Bleichroeder
Thank you.
Michael A. Mussallem - Chairman and Chief Executive Officer
Sure. Next question?
Operator
Our next comes from Larry Biegelsen with Wachovia Securities. Please state you question.
Larry Biegelsen - Wachovia Securities
Thanks for taking the call. Mike, could you please just clarify, you said over 60 patients involved in PARTNER, is that the same as treated, if you could just clarify on that. And I still... I wanted to revisit the hang up on Ascendra. You talked about the poolablity, can you talk about whether there is... it has anything to do with the clinical trial results from the feasibility study in the U.S. Is that part of the issue? It's still unclear to me, what the hang up is with the FDA?
Michael A. Mussallem - Chairman and Chief Executive Officer
Okay. Well first, the 60-patient number is an enrollment number, not a treatment number, okay. And now in terms of the Ascendra trial, we are trying to work through this, right now. There is... the poolability of data; most I think have to do with the maturity of the data. So we've been asked to transfer them all for longer. And we have far fewer cases in the U.S. with the transapical procedure and so trying to do those comparisons, that's been more challenging. FDA has given us more time to collect that data and also given us more patients, gave us an additional group of patients so that we can continue to enroll in the U.S. And we are just been trying to generate that data while we reach a conclusion on how to make sure that this trial is designed in such a way that it's a fair deal.
Larry Biegelsen - Wachovia Securities
So, it has nothing to do with the results of the feasibility, with the trial at the U.S. whether with the results and also can you tell us how many patients have been treated in U.S. Mike? Thanks.
Michael A. Mussallem - Chairman and Chief Executive Officer
Yes.I don't remember how many have been treated in the U.S. area. Its... it must be in the dozens range, but I have to think about what that number is. It must be around 30 or so. But I think it's not so much that results. We don't have enough results to have significance here so that we can say certainly that it is comparable to what we have today.
Larry Biegelsen - Wachovia Securities
Thanks.
Operator
Our next question is coming from Glenn Reicin with Morgan Stanley. Please state your question.
Glenn Reicin - Morgan Stanley
Just a couple of follow ups here and a little bit in the weeds here, just some clarification. Firstly, on the Puerto Rican situation, the charge in the fourth quarter, I assume that's a cash outlay in the fourth quarter?
Thomas M. Abate - Corporate Vice President, Chief Financial Officer and Treasurer
Yes that's correct, Glenn.
Glenn Reicin - Morgan Stanley
Okay and then in terms of the distributor products, those are all in that category, distributed, correct?
Thomas M. Abate - Corporate Vice President, Chief Financial Officer and Treasurer
Correct.
Glenn Reicin - Morgan Stanley
Okay and then the third is can you explain how FX works here. What was the contribution of FX in this quarter? What were you anticipating the contribution of FX being and then next quarter, I just want to think through this, if there is an extra $4 million of FX. How does that affect the bottom line?
Thomas M. Abate - Corporate Vice President, Chief Financial Officer and Treasurer
You know, I will tell you what' happening Glenn is, we had a little bit more FX than we had planned on and actually what we are... the technique we use is a combination of collars and forwards and the rates we have gotten in the play where they are going through the top end of the collars. So what it tended to do in this quarter, is probably caused us 20-30 basis points in margin. As we have this, we don't get the benefit of that further increase. Looking forward to the fourth quarter, if these rates were to continue, it's about double that size, in terms of basis points. And that's one of the reasons that I talked about the margin, they are a little bit differently than last time and to understand those rates they are pretty well above the top end of the instruments that we have in place.
Glenn Reicin - Morgan Stanley
So,I am just... got a little bit too complicated for me. It's just in terms of maybe a net contribution on a dollar basis, the... or EPS basis this quarter versus next quarter?
Thomas M. Abate - Corporate Vice President, Chief Financial Officer and Treasurer
This quarter, next quarter. On the sale side, its... we say it's probably going to be $10 million versus $6 million in sales.
Glenn Reicin - Morgan Stanley
Okay.
Thomas M. Abate - Corporate Vice President, Chief Financial Officer and Treasurer
Alright.But if you remember the improvement and I don't know exactly the number, but the improvement we've seen recently is probably very little. We are going to have the drop through effect because of the fact that we've got to give that back as a result of the contract that we put in place to protect the downside.
Glenn Reicin - Morgan Stanley
Okay. So you are saying, not much.
Thomas M. Abate - Corporate Vice President, Chief Financial Officer and Treasurer
Yes.
Glenn Reicin - Morgan Stanley
Okay, thank you very much.
Thomas M. Abate - Corporate Vice President, Chief Financial Officer and Treasurer
Sure
Operator
Our next question is coming from Kristen Stewart [ph] with Credit Suisse. Please state your question.
Unidentified Analyst
I was wondering if you guys would comment on whether or not one arm of the PARTNER trial may be enrolling faster than the other?
Michael A. Mussallem - Chairman and Chief Executive Officer
Yes, no, sorry Kris, this is one that we are limited not to comment on that. What we will always try and do is give you a current enrollment number whenever we do this on conference call to let you know where we are, but we are... what we do is we jeopardize the trial itself to get into that kind of commentary, so sorry about that.
Unidentified Analyst
Thought I would try, thanks anyway
Michael A. Mussallem - Chairman and Chief Executive Officer
Okay.
Operator
There are no further questions at this time. I would like to turn the call back over to management for any closing comments.
Michael A. Mussallem - Chairman and Chief Executive Officer
Okay. Well, thanks very much for your continued interest in Edwards and Tom and David and I welcome any additional questions by telephone and with that, back to you David.
David K. Erickson - Vice President, Investor Relations
Thank you for joining us on today's call. Reconciliations between GAAP and non-GAAP numbers mentioned during this call which include underlying growth rates and amounts adjusted for special items are included in today's press release and can also be found in the Investor Relations section of our website at edwards.com. If you missed any portion of today's call, a telephonic replay will be available for 72 hours and to access this, please dial 877-660-6853 or 201-612-7415 and use account number 2995 and passcode 256909. I'll repeat those numbers 877-660-6853 or 201-612-7415, the account number is 2995 and the passcode is 256909. Finally, an audio replay will be archived on the Investor Relations section of our website. Thank you very much
Operator
Ladies and gentleman, this concludes today's teleconference. You may disconnect your lines.
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