Ladies and gentlemen, thank you for standing by. Welcome to the Boston Scientific Q2 2014 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Instructions will be given at that time. (Operator Instructions) As a reminder, this call is being recorded. I would now like to turn the conference over to our host, Ms. Susan Lisa. Please go ahead.

Thank you, Linda. Good morning, everyone, and thanks for joining us. With me on today's call are Mike Mahoney, President and Chief Executive Officer; and Dan Brennan, Executive Vice President and Chief Financial Officer. I also have with us today our chief medical officers, Dr. Keith Dawkins and Dr. Ken Stein. We issued a press release earlier this morning announcing our Q2 2014 results, which included reconciliations of the non-GAAP measures used in the release. We have posted a copy of that release as well as reconciliations of the non-GAAP measures used in today's call to the Investor Relations section of our Web site under the heading, Financial Information. The duration of this morning's call will be approximately one hour. Mike will begin our prepared remarks with an update on our business progress and his perspectives on the quarter. Dan will then review our overall Q2 2014 financial results as well as guidance for full-year 2014 and the Q3 2014. During today's Q&A session, Mike and Dan will be joined by Dr. Dawkins and Dr. Stein. Before we begin, I'd like to remind everyone that this call contains forward-looking statements within the meaning of federal securities laws, which may be identified by words like anticipate, expect, believe, estimate and other similar words. They include, among other things, statements about our growth and market share; new product approvals and launches; clinical trials; cost savings and growth opportunities; our cash flow and expected use; our financial performance, including sales, margins, earnings and other Q3 and full-year 2014 guidance; as well as our tax rates, R&D spend and other expenses. Actual results may differ materially from those discussed in the forward-looking statements. Factors that may cause such differences include those described in the Risk Factors section of our most recent 10-K and subsequent 10-Qs and 8-Ks filed with the SEC. These statements speak only as of today's date and we disclaim any intention or obligation to update them. At this point, I'll turn it over to Mike for his comments. Mike?

Thank you, Susie. Good morning everyone. Boston Scientific achieved strong results in second quarter, posting 4% operational sales growth and 17% adjusted EPS growth over the prior year period. This quarter's results increased our confidence in our outlook and we are raising our adjusted EPS guidance for the full year. We remain very confident and enthusiastic about our strategic plan as we execute on our growth initiatives and advance our pipeline. We believe that Boston Scientific is uniquely positioned to drive sustainable double-digit EPS growth, given our global momentum, pipeline and significant opportunity for margin improvement. We are excited about our future as we continue to build throughout the business. We are in the very early innings of launching multiple new platforms that will strengthen the future of the company. These platforms target large disease states that impact patients globally. Such as coronary artery disease, heart failure, stroke, sudden cardiac arrest, vascular disease, pulmonary disorders, Parkinson's disease, severe pain and cancer. Our differentiated pipeline that will be highlighted throughout the call represents a portfolio that delivers unique clinical benefits to patients and physicians while delivering economics savings to our customers. I will now provide some key highlights in the quarter and thoughts on our outlook. Dan will review the financials and 2014 guidance and then we will take your questions. So please note that in my remarks all references to growth are on a year-over-year basis, constant currency unless otherwise specified. So beyond the strong 4% operational sales growth and 17% adjusted EPS growth, I would like to go into some detail on four key highlights of the quarter. First, our diversified and balanced growth across the company. Second, our outperformance in cardiac rhythm management. Thirdly, our above market growth in interventional cardiology. And, fourth, our strong position in peripheral…

Thanks, Mike. I will start with some overall perspective on the quarter before diving into the details. We generated adjusted EPS of $0.21 compared to $0.18 in Q2 of 2013 and exceeded our guidance range of $0.18 to $0.20. The improved performance in Q2 was driven by operational revenue growth, lower royalty expense and a lower than expected tax rate. In addition, this quarter saw a lower R&D spend which was down 130 basis points year-over-year due to the timing of some projects and a focus R&D efficiency. These improvements were partially offset by SG&A spend related to investments in our strategic growth initiatives and core product launches. Despite a higher adjusted SG&A rate this quarter, we posted an adjusted operating margin of 19.8% which was at the high end of our Q2 guidance range of 19% to 20% and roughly flat both year-over-year and sequentially. We remain highly focused on reducing spend and believe we are on track to achieve our profitability goal of roughly of roughly 100 plus basis points of annual operating margin improvement, which will result in a adjusted operating margin approaching 20% for the full year 2014. Below the operating income line, a $4.1 million net gain on investments and a slightly lower than expected effective tax rate along with a 1% reduction in shares outstanding from a year ago also contributed to adjusted EPS of $0.21 or a 17% year-over-year adjusted earnings per share growth. In addition, we generated adjusted free cash flow of $262 million and operating cash flow of $286 million in the quarter. We continue to execute against our goal of consistent revenue growth and believe we are uniquely positioned to leverage that growth to double-digit adjusted earnings growth. Now I will provide a detailed review of our Q2 business performance…

Thanks, Dan. Linda, let's open it up for questions for the next 30 minutes or so. Linda, please go ahead.

(Operator Instructions) We do have a question from the line of Glenn Novarro with RBC Capital Markets. Please go ahead.

Very, very strong ICD quarter. And I'm just wondering if you can provide a little bit more color with respect to the U.S.? Was the better than expected results driven by quad can and S-ICD? And then I had a follow-up on the revenue guidance for the year.

Good morning, Glenn. Yes, we do expect a lot out of that business and we are really pleased with our performance broadly in CRM and in U.S. in particular. Also as Dan highlighted, we really do look at the business on an ongoing basis and the 12-month trend is a plus 2%. We got a lot of heat in the first quarter for a down quarter but over the 12 months it's up 2% and up 4% in the second quarter. You know some of the biggest contributors to that, you highlighted a few, one is a very strong S-ICD momentum. We have a lot of confidence that we will exceed the $75 million target that we gave for the year. And also just the richness of the pipeline that we are delivering in the U.S. with our MINI which is -- the device is about 20% smaller than competitive devices. A lot of uptake by physicians and patients with that product. It represents a significant part of our mix. We are also gaining some nice benefit globally with our quad platform and in the U.S. with the recent approval of the X4 quad generator. So we have a lot of positive news with our pipeline. We offer physicians significant differentiation and our commercial teams are delivering.

And what is early feedback on the quad can? Because I know in the quarter that was launched more in kind of later in the quarter in June. Are you seeing EPs gravitate towards the product? Our research tells us that docs do indeed mix and match a lot more than maybe what we historically know. And is this what's also helping to drive the, what drove the better than expected results in 2Q and going forward.

Yes, it's certainly a part of the equation. You know in Europe we offer the full lead and generator for a quad solution which certainly strengthens our portfolio in Europe. And in the U.S. we do see physicians that are going to mix and match the generator with the leads and they have traditionally done that in other instances as well. And so physicians enjoy the longevity that we offer. Additional pacing vector that’s offered versus competitive systems. And we are seeing that as an opportunity to break into competitive accounts as well as to secure CRT-D business that we may have lost without this offering in the past. So it's certainly a part of the equation of our improved growth.

Okay. And then just quickly, Dan, on the revenue guidance that you offered. Does that include the Bayer acquisition because by our map we thought that would, probably by the fourth quarter contribute $20 million-$30 million.

Glenn, it does not. Since we haven't closed that deal, we have not included that in our guidance for the second half of 2014.

Okay. But if we threw $20 million or $30 million into our model in the foreclosure, is that a reasonable range?

It all depends when you assume a closure. I mean as we have said, it was $120 million business within Bayer. So $10 a month and whatever you assume from close date, that would seem reasonable.

We have a question from the line of Mike Weinstein with JPMorgan. Please go ahead.

Can I start with the SG&A line, because you ended up with obviously so much higher than you guided at the end of the first quarter? So if you could spend some more time on that?

Sure, Mike, happy to. Some of that is expected because we do have a seasonality effect where we have heavier trade show activity as you would know in the second quarter. We do have launch spend. So the Promus PREMIER launch happened a little early then we expected in Japan and we had all the series of launches that Mike went through relative to CRM. Some of it's more unexpected. We do -- as our IRS case moves out further relative to ultimately resolution, we have more fees associated with that. And we do take opportunistic opportunities to look at investments in Europe and emerging markets to drive revenue. So all that, you know some expected and some unexpected. But I would agree, we look at it and not happy with the 38.2% and we would look for that to come down in the back half of '14 and into '15.

And the degree at which it looks like it's -- I'm just looking at it relative to your guidance. The degree to which it looks like it surprised you for the quarter? The tax expense [couldn’t] (ph) be part of that. Why do you think it was so much higher than what you guys thought it would be at the end of the first quarter?

Yes, it's Mike. I wouldn’t say it surprised us. Dan talked about some legal matters we are working through. But we are very confident we will deliver on our full year guidance for SG&A in that 36.5% to 37.5% range. So we are very comfortable with that in the back half. And as we talked about before, with the sales growing, the guidance of 3% to 5%, the ability to drive the operating income margin improvement. And we believe this will be the high point of our SG&A in the second quarter. As we drive down to our guidance for the full year we will drive double-digit EPS growth. So I wouldn’t say it's a big surprise for us. It's well planned. We have a lot of important launches and you are going to see the SG&A rate to creep down in the second half of the year.

Okay. Let me step back from the quarter, Mike, and ask you strategically. Obviously there's been a lot of activity in the healthcare sector over the course of the last several months. Can you just share with us your updated thoughts on the bigger industry consolidation? It's not just consolidations but it's M&A activity, all designed to try and create shareholder value. Can you just talk about how you think M&A plays in Boston Scientific's strategy? And whether you think the healthcare, I wouldn't say competitive landscape, I'd say the healthcare landscape is shifting and whether your strategy alters at all, given some of the deals that have been announced?

Absolutely. Good question. And I would say the recent highly publicized acquisitions that you have read are certainly interesting news. But I would say in general it certainly does not impact our outlook in '14 nor do we see it impacting our strategic plan and our initiatives in any significant way. I think what's important for investors and employees is that the company is delivering today. We are building momentum and we have a strategic plan that’s compelling. It's attainable. We are ahead of the investor day presentation that we provided 18 months ago. And I think more importantly, in our existing markets that we play in today, we play in very big markets well in excess of $30 billion, and we have ample opportunity to grow share in those businesses. And when we think about how we compete, we want to be the preferred innovative, clinical leader in very large disease states. And we have seven of those businesses today. So we will continue to provide tuck-in acquisitions and the right innovation bets to be really clinically differentiated and have scale in those specific disease states. And I think you are seeing the benefit of that strategy with our second quarter performance and the guidance we are reinforcing for the year. So I think the news is interesting but I think the plan that we have in place is very differentiated in the medtech. The ability to grow at or faster than our peer group and the ability that we have we believe to drive margin improvements faster, given the low base that the margins are currently at, which will drive consistent sustainable double-digit EPS growth. So it's really newsworthy but we believe the strategy we have in place is very sound and compelling for investors.

We have a question from the line of Rick Wise with Stifel. Please go ahead.

Mike, you turned in a really healthy EU drug-eluting stent performance, up 8% excluding Germany. A couple of questions. Help us understand when those German tenders occur? And does this have positive implications you'd hope for '15? Does it help us in '14? Maybe a little color there. Number two, maybe you could update us on SYNERGY? I'm assuming in particular SYNERGY is doing well? You had some favorable comments. How do we think about the SYNERGY opportunity now with the U.S. trial enrollment? And maybe in particular we saw some commentary out of Europe with the GHOST-EU Registry that showed very high thrombosis rates for bioabsorbables and this meshes frankly with commentary we heard at PCR about high thrombosis rates. Help us think through the competitive environment for your business broadly and SYNERGY specifically? Thanks.

Sure. I will make some comments on our DES performance and what's driving that and then I will have Dr. Dawkins come in on your second part on the clinical aspects of some of the competitive implications. So just overall, our cardiology team has put ourselves in a very strong position with our global portfolio. And we are seeing the benefit of that in Europe today with our three-tier offering that Dan outlined. SYNERGY, we are very careful with how we price SYNERGY. It's a highly differentiated platform. And so today that mix is growing. But it currently approaches about 30% of our mix where we have launched it. So we are very careful with the pricing on this, as I said. And we have excellent three-tiered portfolio in Europe and it's surrounded by other unique benefits that we have. We just received approval for a new platinum-chromium bare-metal stent for chronic total occlusion. So a lot of investments in the cardiovascular field starting to pay off. So good progress in Europe. And in the U.S., we are really excited about what's happening in the U.S. We grew estimated 10% in the U.S. in DES in the quarter of the heals of Promus PREMIER. And also in Japan we are launching Promus PREMIER really as we speak here. So there is lot of good momentum and then as you look forward, we expect the pivotal SYNERGY data from EVOLVE II in our U.S. IDE trial will be released to AHA in November. So we look forward to the coming of SYNERGY in the U.S., probably late '15. So good work by the cardiovascular team and a pretty rich pipeline that we are kind of tearing out globally. So maybe Dr. Dawkins can comment on your other questions.

Thanks, Rick. I will just say a few words on the first generation bioresorbable vascular scaffold. As you know in the last few months, the recent literature has been has been replete with BVS complications including sub-optimal performance, mal-absorption, fracture displacement, stent thrombosis restenosis, myocardial infarction, and death. And last week in EuroIntervention Online was published the GHOST-EU Registry of BVS, which is the largest European registry, more than 1100 patients. And what caught our attention was the 3.4% annualized death from probable stent thrombosis rate. To put that, that was a one year, and to put that in perspective, the SYNERGY stent thrombosis rate of three years is zero percent admittedly in a more simple patient population. If we just dig down into these stent thrombosis, 87% of these patients were on dual antiplatelet therapy, 13% died and 55% suffered an acute myocardial infarction. So even the editor of that journal who as you know is a big BVS supported, cautioned in a short editorial that this may raise note of caution over the unselected use of BVS in an old comers population or as a workhorse stent. And as a clinician, I want to imply what is best for my patients. And frankly, the 3.4% one year stent thrombosis rate is just not acceptable. So we will obviously, as Mike said, look very carefully and we are very excited by the pivotal EVOLVE data of the SYNERGY stent which will be presented at AHA, more than 1,800 patients. And then that will be followed by a very large diabetic sub-study. So because of the very early strut coverage of SYNERGY and the fact the polymer in the drug disappear abluminaly within a few months, and we have seen already a PCR two-month OCT data showing strut coverage. We are very confident that we will do well in terms of stent thrombosis and obviously the acute performance is impressive. In terms of BVS, we note a low single-digit EU market penetration and that’s the fact that CE Mark was achieved for the product three and half year ago. And I think that compares strikingly with what we are doing with SYNERGY.

A quick follow-up question. On LOTUS you've got the 25 mm approved. Mike, you have 23, 25, 27, the full size complement. How do we think about the LOTUS ramp from here? And will we see data with the 25 mm valve at some point that shows a lower pacer rate than we saw in the REPRISE II data in Paris? Thanks.

Yes. So certainly that data will come out over time once the value has been launched. Maybe Keith you want to comment on the clinical implications?

Yes. So, Rick the 25 is being incorporated in the RESPOND Post Market study. That’s the 1000 patient post market study which just started in Europe and is on track. And we know from the REPRISE II data that more than 50% of patients who needed pacing, there was significant overstretch. In other words, a 27 was put in when the 25 should have been put it but was not available, or a 23 was put in when a 21 should have been put in but was not available. So we are optimistic with the pacemaker rate. We will fall in the RESPONSE study with the addition of the 25 mm and we are working internally on a 21 and 29 mm. When comparing different devices as you know the range of sizes, the aortic, annually that you can cover with different devices is different but we think 29 back to 21 will cover the range.

And we have a question from the line of Bob Hopkins with Bank of America. Please go ahead.

So two questions, one for Dan and then one for Mike. And Dan just to start out on the tax rate. Obviously that stuck out this quarter as quite low, and I'm just wondering for the rest of 2014 if you've upped your EPS guidance a little bit here. How much of that is due to the lower tax rate?

Yes. I think with where we are through the middle of the year, I think we will be comfortable with a 12 to 14 range for this year rather than the 13 to 15 that we had. So we probably see 100 basis point improvement relative to what we had previously signaled on tax.

And did that drive the EPS increase or are there one or two other things that are helping?

It obviously helps but there are a lot of other things that help, most notably including a 3% to 5% growth rate in revenue in the third quarter and overall for the full year.

Okay. And then, Mike, sort of a bigger picture question on revenue guidance relative to some of the long-term thoughts you put out there in 2013. You've had a couple of setbacks in left atrial appendage and hypertension and I'm just wondering if you're still confident in those long-term financial guidance that you provided last year relative to some of these challenges that you've seen? And then also more specifically 2014, is that 100 basis point guidance still stand relative to adjacencies or is that a little lower just because of the timing of WATCHMAN?

Yes, good question. So we are proud that our team is delivering on the commitments we gave despite some of those you have mentioned with hypertension and also the delays in Atritech, which we are hopeful that product will be approved in the first half of '15. But we are still delivering on the commitments that we made and ahead of the commitments that we talked about at the investor day. So I think a couple of things that are really in our favor. Our quad business is really executing nicely. We continue to see a steady performance and a lot of upside in our MedSurg businesses growing above market and strong market positions. A lot of international growth. So we expect continued strong performance there. And cardiovascular business, I won't go through every -- repeat the script here, but we have had a second quarter growth in drug-eluting stents and we are having increased momentum with TAVR. And our rhythm management business is strengthening despite the underperformance of our EP division. So we expect that to improve. So overall despite some of the slippage in the adjacencies -- and you are right, the impact to adjacencies will be less in '14 given the delays of WATCHMAN. But overall, the core business is executing stronger and our business globally is executing very well. Emerging markets growth is up over 15%, represent 10% of the company. So we have a balanced growth across the company and we have a number of also additional tailwinds Dr. Dawkins talked about in the drug-eluting market, as well as some other exciting launches and the uptake of S-ICD.

We have a question from the line of David Lewis with Morgan Stanley. Please go ahead.

Mike, just to think about, or for Dan, the revenue guidance for the year obviously moved around a little bit, perhaps $20 million-$25 million at the midpoint. Just operationally as you think about the year, maybe sort of talk through maybe what drove some of those changes. And then also secondarily, on the endo business, obviously we're accustomed to that seeing much stronger results for the company over the last two to three years. Any specific things you talk about here in the particular quarter as it relates to endo and traction you're expecting for the remainder of the year in that business?

Thanks, David. I think as you look at the growth -- and it's part of what Mike had just answered. So we have taken WATCHMAN out for the back half of the year as we anticipate approval for the first half of '15. So obviously absorb that but still delivering on the 3% to 5% for the full year. So it's really just tweaking around the edges to tighten the range as we go through the rest of the year. But still feel like that 3% to 5%, that zone we went in for the first half of this year, pulled through for the back half of the year as well for a lot of the reasons that Mike just outlined in the answer to the last question.

And just in terms of the endoscopy business, it's not a concern for us. That business is very healthy. We did have a slow, little bit of a slowdown in the second quarter. We had some key product launches that will likely shift to late third quarter, fourth quarter. But overall, we don’t see on a year-over-year basis, any anticipated slowdown with our endoscopy performance.

Okay. And then Dan maybe just to follow up quickly on SG&A. One thing we saw in the fourth quarter last year was sort of the reinvestment to take advantage of some of this tax potentially. Is that sort of what we're seeing again here in the second quarter? Just you are being a little opportunistic given you have a little more flexibility, or is this really just one-time spending here and there that you expect to resolve and maintain your guidance for the year?

Yes. No, and that’s a good question. I think first just to clarify relative to the overall. The 38.2% that I mentioned, that’s the adjusted SG&A rate, which is the rate for the quarter. As you look at being opportunistic, we will always be opportunistic within a given quarter if we see opportunity but as Mike mentioned earlier, we are still laser focused on delivering on the operating profit targets that we have. So we will make tradeoffs between gross margin, SG&A and R&D, but still very focused on the operating margin targets and the double-digit EPS growth.

We have a question from the line of Bruce Nudell with Credit Suisse. Please go ahead.

Mike, just looking at the two quarters back-to-back, 1Q and 2Q, for the S-ICD or for the ICD franchise. I mean, should we be -- and I know there are puts and takes. There's the replacement headwind, there's the quad situation. Should we be thinking about this year as kind of having a masking effect on the progress you're really making and maybe 50 to 100 basis points in worldwide share? And that the real full impact of the transformation in CRM or the ICD franchise really not being evident fully till something like 2016, where you have your own CRT-D product, full system product in the market?

Yes, I think that’s a fair way to characterize it. I think we are very comfortable in stating that we are gaining share in de novo ICD. So physicians are choosing our platform portfolio more often. And as you said that success has been hampered by not having a full launch of a quad system which we now have in Europe but we don’t have that quite yet in the U.S. And the replacement headwind -- you know quite frankly due to some of the battery longevity benefits that we deliver. So we think that replacement headwind will taper and right itself in 2016. So we are facing those two headwinds and that’s being offset with positive growth due to the strong de novo ICD momentum and patient momentum that we have. So in the future, once neutralized for that replacement headwind and the full launch of quad, would better show the strength of the portfolio that we are delivering. I think if you look to Europe, we do have the portfolio today. We have the full quad capabilities, the S-ICD. We are battling the replacement headwind, at least the overall position is stronger in Europe given that trend.

And I guess a follow-up for my good friend, Keith. Just looking at the PREVAIL results and the body of evidence, really doesn't look like there's any smoking gun in LAA and everybody's very confused by the need for a third panel. And the only thing that really strikes me is that the great utility of this technology would be in patients who are both at high stroke and bleeding risk. And that trial has never been done where people who are truly contraindicated for anticoagulants are tested, but they're having registries that speak to that. I mean are we on the right track in thinking that it's really an indication question that the FDA may have and that the compendium of evidence really speaks to safety even in anticoagulant intolerant patients?

Thanks, Bruce. I think I should pass that comment to my colleague, Ken Stein, who is CMO of the CRM division. Because WATCHMAN lodges in that division and Ken has been spending a few minutes on the forthcoming panel.

Yes, thanks. Thanks a lot Keith and thanks for the question, Bruce. We are really not able to get into any public details about our ongoing negotiations with FDA or speak for them in terms of what their concerns are that led to us go to this unprecedented third panel. I can tell you again, our belief is that the data as it exists today is still supportive of and consistent with the data that we presented to the panel last December. And that got us the overwhelmingly positive 13 to 1 votes in favor of safety, efficacy and positive benefit risk for the populations that have been studied in the large randomized trial. I think the only other thing I might want to clarify just in terms of your question, you know it's our belief that if you look into the populations that were studied in, PREVAIL and PROTECT and our two registries, CAP and CAP 2. Those are populations at high risk of stroke and those are population with high bleeding risk based on their CHADS VASc scores and their HAS-BLED scores. So we think that the populations that we studied and the indications that we are seeking really are the appropriate populations for this device.

We have a question from the line of Larry Biegelsen with Wells Fargo. Please go ahead.

This is David Brill for Larry. So first, second half 2014 EPS guidance, looked like it was $0.38 to $0.42. You know why would second half be lower than $0.41 in the first half?

The biggest piece of that is seasonality. Q3, particularly in Europe is the slowest sales quarter of the year. So you lose a little bit of sales, the industry loses sales in the third quarter. So that’s the primary driven as to why the second half is lower.

Great. And second, you talked about some of the headwinds in neuromodulation. Can you give us a little bit of color about how we should think about the neuromodulation in the U.S. going forward?

Sure. So in neuromodulation the business continues to do well. We did have -- we highlighted in the call, a slowdown in the second quarter and we anticipate a slowdown in the second half, given the annual comps. You the comparables in the second half of the year will be against a 30% growth comp. So that will be a challenge for us in the second half of the year but we still delivered positive growth in the second quarter despite some of those reimbursement changes. So as we look forward in the future, we do expect this to be a continued strong mid to high single digit growth market and we have a lot of innovation that we are launching out. The Spectra platform and more things in the pipeline that we will outline at investor day in the first quarter in '15. So our growth will slow down in the second half given those comparables. But as we anniversary those comps in '15 and strengthen the pipeline in a market that we believe that will settle into the kind of mid-single digit to high-single digit growth rate, we expect to outperform the market.

Linda, there is time for one more please.

Okay. Thank you. We do have a question from the line of Brooks West with Piper Jaffray. Please go ahead.

Thanks for fitting me in. One on CRM. Can you update us on where you are with the NAVIGATE X-4 trial and kind of how we should think about that impacting your ICD results? And then I had a follow-up on cardiology.

Dr. Stein, you want to take that question?

Yes. I mean I don’t -- the NAVIGATE trial is on pace, we are still projecting U.S. approval of our quad pole leads in 2016. I don’t think that the fact that the trial is running has any material effect on the financial results that we have reported for the year.

Okay. But, Ken, you do get revenue from the trial, correct?

I am going to have to refer it to Dan on how that actually gets booked into the P&L.

Yes, Brooks. Yes, but nothing that’s materially going to move the needle. So I wouldn’t factor it into your model.

Okay. Great. And I guess my follow-up is on some of the other cardiology products. You know you have got IVUS FFR, you have now got a coronary drug-eluting balloon. You still got I think good momentum in the CTO device. Can you talk about the ability of those devices or maybe quantify a little bit the ability of that other bucket of stuff to impact the cardiology franchise going forward?

Sure, I can take that Brooks. The other IC, and again it's almost a shame to call it the other IC because there is so many good products in that category. But the products that we have in that to treat the complex PCI have significantly contributed to the overall IC franchise and actually to the company. Because if you recall, that’s a franchise that was going backwards in prior years. And now that that has forward momentum and it's not just one product. It's IVUS, you just saw we announced the new bare-metal stent launch in CTO devices, Rotablator. There is a list of products in there that are all rejuvenated from a product portfolio perspective and contributing to growth in that franchise as well as IC. I don’t know, Keith, if you have might any other comment as well.

You know I think, Brooks, also these are areas that have been neglected somewhat but Boston Scientific. So we haven't produced a bare metal stent for ten years and we have rarely refurbished the IVUS business, obviously new catheter, new software and then anticipate that we can integrate FFI next year on a very competitive wire. So we have focused a lot on the core IC business which previously perhaps just escaped our attention.

With that, we’d like to conclude the call. Thanks for joining us today. We appreciate your interest in Boston Scientific. And before you disconnect, Linda, will give you all the pertinent details for the replay. Thank you.