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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________________________________________
`MEDTRONIC, INC., and
`MEDTRONIC VASCULAR, INC.,
`
` Petitioners,
`
`vs. Case No. IPR2020-00126
` U.S. Patent No. 8,048,032
`TELEFLEX INNOVATIONS
`S.A.R.L.,
` Patent Owner.
`___________________________________________________
`
`IPR2020-00126 (Patent 8,048,032 B2)
`IPR2020-00127 (Patent 8,048,032 B2)
`IPR2020-00128 (Patent RE45,380 E)
`IPR2020-00129 (Patent RE45,380 E)
`IPR2020-00130 (Patent RE45,380 E)
`IPR2020-00132 (Patent RE45,760 E)
`IPR2020-00135 (Patent RE45,776 E)
`IPR2020-00136 (Patent RE45,776 E)
`IPR2020-00137 (Patent RE47,379 E)
`IPR2020-00138 (Patent RE47,379 E)
`____________________________________________________
`
` VIDEOCONFERENCE VIDEOTAPED
` DEPOSITION OF
` CRAIG A. THOMPSON, M.D.
`DATE: December 7, 2020
`TIME: 8:00 a.m.
`PLACE: New York, New York
`(via videoconference)
`JOB NO.: MW 4338343
`
`REPORTED BY: Dawn Workman Bounds, CSR
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`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
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`Medtronic Ex-1817
`Medtronic v. Teleflex
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`1 A P P E A R A N C E S
`2 (ALL APPEARANCES VIA VIDEOCONFERENCE)
`3 ON BEHALF OF PETITIONERS:
`4 CYRUS A. MORTON, ESQ.
` WILL MANSKE, ESQ.
`5 ROBINS KAPLAN LLP
` 2800 LaSalle Plaza
`6 800 LaSalle Ave
` Minneapolis, MN 55401
`7 612.349.8500
` camorton@rkmc.com
`8 wmanske@RobinsKaplan.com
`9
`10 ON BEHALF OF PATENT OWNER:
`11 ALEX S. RINN, ESQ.
` DEREK VANDENBURGH, ESQ.
`12 JOSEPH W. WINKELS, ESQ.
` CARLSON CASPERS VANDENBURGH & LINDQUIST, PA.
`13 Capella Tower, Suite 4200
` 225 South Sixth Street
`14 Minneapolis, MN 55402
` 612.436.9623
`15 arinn@@carlsoncaspers.com
` dvandenburgh@carlsoncaspers.com
`16 jwinkels@carlsoncaspers.com
`17
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`ALSO PRESENT:
`
` Greg Smock, Teleflex
`
` Chris Buller, Teleflex
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` Adam Wallin, Videographer
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`1 P R O C E E D I N G S
`2 THE VIDEOGRAPHER: Good morning. We are
`3 going on the record at 8:00 a.m. Central Time, on
`4 December 7, 2020. This is media unit 1 of the
`5 video-recorded deposition of Dr. Craig A. Thompson being
`6 taken via Zoom, and taken by counsel for the Petitioner
`7 in the matter of Medtronic, Incorporated, and Medtronic
`8 Vascular, Incorporated, versus Teleflex Innovations
`9 S.A.R.L., in the United States Patent and Trademark
`10 Office before the Patent Trial and Appeal Board, Case
`11 Number IPR2020-00126.
`12 My name is Adam Wallin from the firm of
`13 Veritext, and I'm the videographer. The court reporter
`14 is Dawn Bounds from the firm Veritext.
`15 Will counsel please identify themselves
`16 for the record.
`17 MR. MORTON: This is Cyrus Morton of the
`18 Robins Kaplan firm on behalf of Petitioner Medtronic.
`19 With me also from Robins Kaplan is Will Manske.
`20 MR. WINKELS: And this is Joe Winkels on
`21 behalf of patent owner. With me with the -- and I'm with
`22 Carlson Caspers. With me is Derek Vandenburgh and Alex
`23 Rinn from my firm, as well as Greg Smock and Chris Buller
`24 from Teleflex.
`25 THE VIDEOGRAPHER: Will the court reporter
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`Page 3
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`Page 5
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`1 please swear in the witness.
`2 THE REPORTER: Due to the need for this
`3 deposition to take place remotely because of the
`4 government's order for physical distancing, the parties
`5 will stipulate that the court reporter may swear in the
`6 witness over the videoconference and the witness has
`7 verified that he is in fact Dr. Craig Thompson.
`8 Agreed, counsel?
`9 MR. MORTON: Agreed.
`10 MR. WINKELS: Agreed.
`11 CRAIG A. THOMPSON, M.D.,
`12 duly sworn via videoconference as stipulated by counsel
`13 was examined and testified as follows:
`14 EXAMINATION
`15 BY MR. MORTON:
`16 Q. Good morning, Dr. Thompson.
`17 A. Good morning, Mr. Morton.
`18 Q. Have you had your deposition taken before?
`19 A. Yes.
`20 Q. Okay. And did you have a chance to prepare for
`21 this deposition with counsel?
`22 A. Yes.
`23 Q. How much time would you say you spent preparing
`24 for this deposition?
`25 A. I've read by declaration, spoke with the
`
`1 I N D E X
`2 WITNESS: CRAIG A. THOMPSON, M.D. PAGE
`3 EXAMINATION BY MR. MORTON.......................... 5
`4 EXAMINATION BY MR. WINKELS......................... 73
`5 EXHIBITS PREVIOUSLY MARKED/REFERRED TO
`6 No. 2215: Declaration of Dr. Craig Thompson....... 6
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`1 attorneys. Couple of hours, maybe.
`2 Q. All right. Do you have any trouble hearing my
`3 questions today over Zoom?
`4 A. No, sir, I hear you very well.
`5 Q. Is there any reason why you can't give
`6 complete, truthful, and accurate answers to my questions
`7 today?
`8 A. No.
`9 Q. So let's take a look at your declaration,
`10 starting paragraph 1.
`11 You say you spent 17 years practicing; is
`12 that right?
`13 A. Correct.
`14 Q. So that means you started in 2003?
`15 A. Yes. That's my first independent job out of
`16 training. My -- I started medical school in 1991.
`17 Started my inter -- my residency training in 1995, my
`18 cardiology in 1998, which is where I was really
`19 clinically engaged in cardiovascular medicine primarily
`20 and started catheterizing then.
`21 Interventional cardiology and vascular
`22 medicine in 2000 through effectively 2003. And then
`23 first independent job out of training was in 2003, which
`24 is where I arrived at that figure.
`25 Q. Okay. I want to focus on the time period prior
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`1 that fair?
`2 A. Yes.
`3 Q. Okay. And so how often did that happen when
`4 you have these complex PCI procedures? Was that common?
`5 Is that what defined it as complex to you? How would you
`6 describe that?
`7 A. I would say it happened commonly, but it does
`8 not -- that in and of itself does not define complex.
`9 Complexity can be the -- require different
`10 devices for different aspects of coronary anatomy. So it
`11 wasn't all about the guide support, but quite frequently
`12 it travels in packs, so it's not mutually exclusive that
`13 you have complex anatomy and have guide catheter
`14 problems. They go hand-in-hand.
`15 Q. So you have maybe 2,000 procedures.
`16 And I think -- did you say 60 percent were
`17 complex PCI?
`18 And then how much of those did you have
`19 issues with guide catheter back-out?
`20 A. In complex -- at that point in time it was
`21 2,000 procedures. Now it's a lot more higher, to be
`22 clear. And I would say it would be the majority of the
`23 cases that you have complexity. There are challenges
`24 with guide catheter issues at that point in time.
`25 Q. Okay. And I understand you've done more
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`Page 7
`1 to 2006, May 2006, when the patents in this case were
`2 filed. Okay?
`3 A. Okay.
`4 Q. How many interventional cardiology or PCI
`5 procedures would you say you were involved in before
`6 2006?
`7 A. Oh, gosh. Let me think.
`8 From 1998 to 2006, my -- probably my
`9 average overall procedure rate for overall
`10 catheterizations, including diagnostics, were about 500 a
`11 year. So that would be three -- six years, several
`12 thousand. And if we said 60 percent of those were PCIs,
`13 then it would -- it would be somewhere between 1,500 and
`14 2,000, I would suppose. Maybe more. The interventional
`15 fellowship was a little bit more heavy on interventional
`16 procedures. So let's say 2,000 as an estimate.
`17 Q. Okay. And out of those, what -- how many or
`18 what percentage were -- would you consider complex PCI
`19 procedures?
`20 A. 60 to 70 percent.
`21 Q. Okay. And when you encountered a complex PCI
`22 situation, how often did you try to -- let me just -- let
`23 me start over.
`24 When you have a complex PCI situation, you
`25 might have the guide catheter back out of the ostium; is
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`Page 9
`1 procedures post 2006. I'm just trying to kind of break
`2 down your work prior to 2006.
`3 A. Sure.
`4 Q. So if you have a complex PCI procedure and if a
`5 lot of the time you experience back-out, how often would
`6 you try using a different guide catheter?
`7 A. In this we're -- to clarify your question,
`8 we're still speaking prior to 2006?
`9 Q. Yep.
`10 A. Frequently. Frequently that is -- one of the
`11 countermeasures is either a larger or more supportive
`12 guide catheter at that point in time, depending on the
`13 circumstances. Oftentimes if a guide catheter is in
`14 position, you try different countermeasures; but
`15 oftentimes it's not as good as changing the guide
`16 catheter at that point in time.
`17 Q. Okay. When you say frequently, can you put any
`18 more precise number on that?
`19 A. Not really. I mean I would -- I would -- if I
`20 had to guesstimate, I would put it roughly half the time
`21 that it's a guide catheter issue.
`22 Q. Okay.
`23 A. And the issue would be guide catheter. The
`24 challenge at that point in time would be if you didn't
`25 have countermeasures once you had some of your equipment
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`Page 10
`1 in place. So switching out the guide catheter became a
`2 major impediment, although oftentimes the primary barrier
`3 probably two-thirds of the time would have been a guide
`4 catheter problem. Wrong selection or just insufficient
`5 guide support even with a good selection.
`6 Q. Okay. And so when you did switch out and use a
`7 different guide catheter, I assume you were able to have
`8 successful procedures with that?
`9 A. Much of the time, yes, with a different guide
`10 catheter and countermeasures. But not all of the time,
`11 no.
`12 Q. All right. So same question.
`13 You're doing complex PCI prior to 2006 and
`14 you experience a back-out problem with the guide
`15 catheter.
`16 How often would you respond to that by
`17 attempting to deep-seat the guide catheter?
`18 A. Seating the guide catheter more aggressively
`19 is -- which is deep-seating -- is one of the initial
`20 countermeasures before you start doing others.
`21 And I would say that trying to get the --
`22 that would be the first thing to do, to maybe try to seat
`23 the guide a little bit more deeply, a little bit more
`24 aggressively to see if that can help solve the problem.
`25 So that would be the great majority of the
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`Page 11
`1 time. Once a wire is down the coronary artery, before
`2 you -- because at that point it's very difficult to
`3 switch the guide catheters without losing a position and
`4 risking patient safety.
`5 Q. All right. Same question.
`6 How often would you use a buddy wire?
`7 A. In positions where a guide catheter was backing
`8 out, at that point in time, that would be a majority --
`9 after positioning the guide catheter more deeply, that
`10 would be one of the earlier secondary maneuvers, so it
`11 would be a large minority of the time.
`12 And I would say if you polled people
`13 worldwide, that would be the great majority of the time.
`14 I'd just employ different countermeasures rather than
`15 buddy wire at that stage in my career.
`16 Q. All right. And then finally, same question,
`17 that stage in your career, did you experience back-out of
`18 the guide catheter.
`19 How many times did you ever attempt the
`20 mother-and-child technique?
`21 A. Low single digits. And that would be after my
`22 fellowship. I tried to experiment with modified
`23 mother-and-child techniques, which was of a -- good idea
`24 but of limited success.
`25 Q. All right. Did you -- and did you perform
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`Page 12
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`1 successful complex PCI procedures with the
`2 mother-and-child technique?
`3 A. Yes.
`4 Q. And can you explain, where was that again?
`5 A. Where?
`6 Q. Yeah.
`7 A. Largely at -- if we're speaking of pre-2006, it
`8 would have been when I was an independent operator at
`9 Dartmouth. We did not do this -- we did not utilize that
`10 particular technique when I was at Harvard in training.
`11 Q. And how many successful complex PCI procedures
`12 with the mother-and-child technique would you say you
`13 did?
`14 A. Hundreds. Oh, with mother-and-child, no. I'm
`15 sorry. Complex PCI would be hundreds.
`16 With mother-and-child, maybe couple of
`17 dozen, something along those lines, prior to 2006. We
`18 just simply didn't have the technology.
`19 Q. Okay. So then after -- how about after 2006,
`20 did you do any additional mother-and-child procedures?
`21 A. Yes.
`22 Q. And can you tell me when -- when and where that
`23 was and how many you did?
`24 A. Dartmouth, Yale, as a traveling operator in
`25 five continents, and ultimately at NYU; and thousands.
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`1 Q. Okay. And how many?
`2 A. Thousands.
`3 Q. You did thousands of mother-and-child
`4 techniques?
`5 A. I do it nearly every day that I'm in the cath
`6 lab these days, yes.
`7 Q. Okay. So when you say you did thousands, are
`8 you equating using rapid exchange versions?
`9 A. Yes.
`10 Q. Of mother-and-child?
`11 A. Yes.
`12 Q. Okay. I guess I should clarify that then?
`13 So when you did the two dozen at Dartmouth
`14 prior to 2006, was that with a full-length child catheter
`15 or with a rapid exchange version?
`16 A. A full-length child catheter, and it was a
`17 modification using a standard short guide catheter with a
`18 long standard guide catheter, which aren't, you know, as
`19 it turns out, aren't appropriately shaped to
`20 atraumatically and successfully do this in the
`21 coronaries. More in the peripheral vasculature.
`22 But we're speaking about coronaries today,
`23 and it was a -- it was a little bit of a boutique attempt
`24 to try to counteract a very difficult problem that we had
`25 at the time.
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`1 Q. Okay. And other than those two dozen, have you
`2 performed any other mother-and-child technique complex
`3 PCI procedures with a full-length child catheter?
`4 A. In the coronary circulation?
`5 Q. Yeah.
`6 A. Since -- what time frame are we speaking of
`7 now?
`8 Q. Any time. Setting aside those couple of dozen
`9 you did at Dartmouth prior to '06, have you done any
`10 other using a full-length child catheter?
`11 A. Oh, no.
`12 Q. Okay. And so all of the mother-and-child
`13 techniques that you've done after that - I think you said
`14 thousands - those were all with a rapid exchange version
`15 of the child catheter?
`16 A. That's correct.
`17 Q. All right. Let's jump to paragraph 6 of your
`18 declaration.
`19 A. I'm sorry. Could you repeat that, please?
`20 Q. Sure. Paragraph 6 of your declaration.
`21 A. Okay. Got it. I'm there.
`22 Q. So here you're talking about when you start a
`23 procedure, you don't know if it's going to be --
`24 necessarily if it's going to be complex at first, right?
`25 A. Not entirely, no.
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`1 Q. You don't know, for instance, if the guide
`2 catheter is going to back out?
`3 A. That's correct. Sometimes -- there are times
`4 where you can anticipate this and prepare up front, and
`5 there are times where it's unanticipated.
`6 Q. Okay. So if you anticipated it, would you plan
`7 from the get-go, if you will, to do something to address
`8 that?
`9 A. Are we talk -- are we speaking current --
`10 current era?
`11 Q. Sure. Just in general, in your practice,
`12 trying to understand how these procedures go.
`13 A. Yes. Yes, if I anticipated it being difficult,
`14 I would start thinking about countermeasures proactively
`15 rather than reactively.
`16 Q. All right. So let's -- let's focus first on
`17 the situation where you don't know if you're going to
`18 have back-out, and you get into the procedure and you do
`19 have a guide catheter back-out problem. Okay?
`20 A. Yes.
`21 Q. So if the guide catheter backs out of the
`22 ostium, what's the -- what's the first thing you have to
`23 do? Do you have to get it back in?
`24 A. Yeah. Yes, if it starts backing out, you
`25 naturally would re-engage the ostium of the coronary
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`1 artery.
`2 Q. Then how you would you decide if you need to --
`3 I think the first thing you said you'd consider is -- is
`4 whether you need to deep-seat the guide catheter?
`5 A. Current era, I wouldn't deep-seat it down the
`6 coronaries. I'd pull a guide extension.
`7 Q. Okay. Well, maybe we should focus back to when
`8 you would consider these options we talked about earlier,
`9 then go through your list of options.
`10 A. We're -- I just want to be clear. We're back
`11 to pre-2006?
`12 Q. Yes.
`13 A. Okay.
`14 Q. I think that will work better.
`15 A. Yes. So in that circumstance I would reseat
`16 the guide catheter, realize that we're going to have a
`17 device delivery challenge, and consider what my next
`18 options would be.
`19 Q. Okay. And what would you do -- what would your
`20 first option be?
`21 A. From prior to 2003, it would be putting a
`22 second wire in. It's called a buddy wire, but try to
`23 put -- to essentially get more coaxial support down a
`24 coronary artery, sometimes a third wire even.
`25 After 2003, when I was a little bit more
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`Page 17
`1 independent and more developed, it would be a second
`2 guidewire, not down the vessel that we were going to
`3 deliver the therapy, balloons and stents and so forth,
`4 but into a branch, a different artery, and put a
`5 balloon -- an angioplasty balloon in that artery. It's a
`6 technique called an "anchoring" technique.
`7 And when you inflate that particular
`8 balloon, it gives security in the other branch of the
`9 artery, but it keeps the guide more engaged and offers
`10 more support at the coronary ostium for device delivery
`11 down the index coronary artery, the one that you're
`12 trying to deliver therapy to.
`13 And there's various ways that you can do
`14 this anchoring technique. There's side-branch anchoring,
`15 so you're in a different part of the vessel altogether
`16 with a balloon. And there were times in that era we were
`17 also delivering big bulky stents, that you could do it
`18 over a second wire, down the artery that you're
`19 delivering treatment, and anchor in that particular
`20 vessel with a balloon.
`21 But the premise is essentially the same,
`22 is you've got a second wire, you've got a second system
`23 in, you're inflating a balloon, and this gives a little
`24 bit of grip, if you will, within the coronary artery that
`25 keeps the guide more supported to be able to deliver the
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`1 therapy you're trying to get to do the right -- well,
`2 right patient, right place, right time, if that makes
`3 sense.
`4 I can clarify this. I know it may be a
`5 little bit confusing, but that would be -- that would
`6 have been my countermeasures from 2003 to 2006.
`7 Q. I see. So it's a little more elaboration on
`8 use of a buddy wire to kind of also do this anchoring
`9 technique?
`10 A. Well, it's in addition to the buddy wire.
`11 The buddy wire, when we describe that,
`12 what we're really speaking about is you put a second
`13 wire, even a third, but typically a second wire is going
`14 parallel to the wire that you're going to use to
`15 deliver -- well, we'll say balloons and stents for
`16 simplicity. It may be other devices. That's what a
`17 buddy wire is.
`18 And it gives you a little bit of extra
`19 support. It helps with some coaxiality, meaning
`20 alignment of the guide catheter with the vessel, but not
`21 a lot. And that's the reason that that technique is
`22 fairly insufficient.
`23 What I speak about with the anchoring
`24 techniques is putting a balloon over a second wire,
`25 inflating it within the coronary tree, which allows you
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`1 to kind of secure a position. If you think about it,
`2 it's almost like grabbing the artery from the inside so
`3 that you can pull something over the first wire beside it
`4 to deliver therapy to the index lesion within the
`5 vessel.
`6 Q. Okay. So focusing still on this same period,
`7 pre-2006, when would you decide that the countermeasure
`8 you should use would be to deep-seat the guide catheter?
`9 A. I would deep-seat the guide catheter in radial
`10 procedures, but I wasn't doing them as -- excuse me -- as
`11 frequently at that point in time. But smaller guide
`12 catheters in certain arteries, but not all of them.
`13 So we effectively have three arteries that
`14 we work in on the surface of heart; and these arteries
`15 have branches, the branches have branches. There's one
`16 artery called the right coronary artery where it was
`17 probably a little bit more common to deep-seat a guide
`18 catheter.
`19 I think there would be more hesitation to
`20 do it in the left coronary where two of the arteries are
`21 connected, and damage there could be catastrophic to a
`22 patient. So it's a little bit dependent on time and
`23 circumstance.
`24 But I think once the guide catheter starts
`25 backing out, prior to 2006, you have two choices. You
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`1 either pull your equipment out, put in a new guide
`2 catheter, try again, or you -- you would try to use some
`3 of these countermeasures.
`4 For me, it was mostly using
`5 countermeasures because most -- like most interventional
`6 cardiologists, once you have purchase or wire access
`7 across your index lesion, you don't want to give that up;
`8 because if you do, there is a chance you can't get it
`9 back. There's a chance that things have gotten roughed
`10 up, and you would never be able to rewire it, and now you
`11 have a patient in extremis that you can't solve.
`12 So that was the state of affairs at that
`13 point in time.
`14 Q. Okay.
`15 I thought you testified earlier that
`16 you -- it was fairly common to try a different guide
`17 catheter. So maybe you can explain to me in what
`18 circumstances would you decide to, as you say, pull
`19 everything out and try a different guide catheter?
`20 A. It'll be circumstances where I felt like I did
`21 not cause damage to the artery, that it was relatively
`22 easy to get these small guidewires across again. And so
`23 really more in the early aspects of the case where you
`24 realize this is going to be difficult. So I would say
`25 the first consideration would be I'd put a guide catheter
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`Page 21
`1 in and -- and I can tell just with the angiograms before
`2 we start wiring, before we manipulated the lesion, that
`3 the guide catheter wasn't going to offer me the support
`4 that I needed. And I was anticipating a very difficult
`5 case.
`6 Those are good circumstances to just
`7 change out the guide catheters altogether and start from
`8 scratch.
`9 Second circumstance would be that it would
`10 be very -- fairly difficult that I'm not in a safe
`11 position to try to seat the guide catheter deeply down
`12 the coronary or I was in a situation where I did
`13 deep-seat the guide catheter down the coronary and the
`14 patient destabilized, meaning they became very sick, they
`15 couldn't tolerate it, or realized that there was aspects
`16 of their anatomy that was -- that would -- that could
`17 be -- that could cause them to destabilize and get very
`18 sick. And in that circumstance it becomes a fire drill
`19 and a safety issue for the patients.
`20 But I would say earlier in the case it
`21 would be seating the guide catheter a little bit more
`22 deeply or recognizing that I need to try a more supported
`23 guide catheter that could stay a little bit further back,
`24 closer to the ostium or the beginning of the coronary.
`25 That would be good situations to try to switch out the
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`1 guide catheter.
`2 There were times -- or had been times at
`3 that point in time which was a very inconsistent
`4 phenomena where you actually have a wire down the
`5 coronary and you try to figure out a way to keep the wire
`6 in position and exchange your guide catheter over that;
`7 and it's hard to do, it's not reproducible, it's not
`8 teachable. I've done a number of those but it's -- it
`9 doesn't really -- it's really a -- really a challenge for
`10 patient safety and patient care.
`11 Does that answer your question?
`12 Q. I think so. Thank you.
`13 A. Okay.
`14 Q. So then let me ask you about the other
`15 potential option, the mother-and-child option. Okay?
`16 A. Yes.
`17 Q. So that also I guess if you had already started
`18 a procedure, you would have to start over similar to
`19 switching out the guide catheter; is that right?
`20 A. If I were to use a -- are you speaking
`21 specifically pre -- I want to clarify. Pre-2006 and
`22 using this modified mother-and-child technique with
`23 standard catheters; is that what we're speaking to?
`24 Q. Yeah. Or maybe -- is it all right if I refer
`25 to it as full-length mother-and-child as opposed to a
`
`1 technique?
`2 A. Because I -- my -- the space that I gravitated
`3 to and kind of I knew of being my space over the past 20
`4 years was managing complex coronary disease with a
`5 philosophy that the coronaries are my problem to
`6 technically figure out, but the patients have the same
`7 problem.
`8 So if you, Mr. Morton, for instance, had
`9 angina, all you care is that if you have a coronary
`10 blockage that's causing your problem.
`11 And the technical issues are my problem to
`12 figure out. And I didn't want to be in a position that I
`13 had to say no to a patient because of something being a
`14 little bit harder than easier to do. And that's kind of
`15 been the general -- my general philosophy; and, you know,
`16 for better or for worse, I'm on old man and I'm sticking
`17 to it. But that's the -- that was the state of affairs.
`18 So I had to try to figure out ways to
`19 troubleshoot these problems. So the anchoring technique
`20 I told you about a little while ago, these putting three
`21 wires instead of two wires, deep-seating coronaries,
`22 figuring out new ways to do balloon anchoring, or
`23 modifications. Mother-and-child was an attempt at
`24 creative solutions to manage problems that are very, very
`25 difficult.
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`1 rapid-exchange mother-and-child?
`2 A. Yeah, you certainly would have a big change in
`3 your workflow.
`4 These things at that point in time, prior
`5 to 2006, couldn't be easily anticipated upfront at least
`6 in the coronary circulation, which is what we're speaking
`7 to today. So you would need to plan ahead. You would
`8 need longer guidewires; and in order to make that
`9 accommodation, you would have to have -- the so-called
`10 mother catheter would have to be a shorter catheter.
`11 And those are ones that aren't standard,
`12 weren't actually universally available then. So we would
`13 actually have to cut guide catheters and put them
`14 together to create a mother catheter in order for a
`15 standard catheter to have the length to get through it.
`16 Remember, the child catheter needs to be -- if you're
`17 using over-the-wire systems needs to be longer.
`18 So there's a lot of planning and
`19 modification. So it was a huge disruption to the
`20 workflow to do that, in addition to the fact that it's
`21 cumbersome and ineffective. But -- or not universally
`22 effective. But that was the state of affairs prior to
`23 2006.
`24 Q. So why were you experimenting with a
`25 mother-and-child -- full-length mother-and-child
`
`1 Q. Okay. So focusing still on the full-length
`2 mother-and-child you experimented on --
`3 A. Yes.
`4 Q. -- again, why did you think that that would be
`5 a -- potentially a good solution to the problems you were
`6 facing in complex PCI procedures?
`7 A. Because if we can get a -- if we can get
`8 something as supportive as a guide catheter more deeply
`9 into a coronary artery -- and this has played out over
`10 years. And I think it's going to be, I guess, the
`11 subject of what we're talking about this morning -- but
`12 if you can get a guide catheter coaxially seated deeply
`13 in a coronary artery, it puts you in a position for
`14 success that -- that virtually all these other
`15 techniques, putting extra wires down and balloons in
`16 branches and, you know, some of the things that I've
`17 described, it is -- it puts you in a position to
`18 successfully and safely accomplish goals in delivering
`19 therapy to a patient.
`20 Q. Okay. Did you think that full-length
`21 mother-and-child you experimented with would increase
`22 back-up support?
`23 A. Yes.
`24 Q. And in the experiments you did, did that turn
`25 out to be the case?
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`1 A. Well, first I would say it's not experiments.
`2 I want to -- I would maintain that putting guide
`3 catheters in coronary arteries would be standard care.
`4 So I would like to clarify that. Granted, it was a
`5 creative utilization of nonstandard devices.
`6 But, yes, I did think that it would put me
`7 in a better position to manage complex coronary disease
`8 than was what I viewed to be insufficient second and
`9 third tier options.
`10 Q. Okay. And aside from increased back-up
`11 support, was there any other aspect of it that you
`12 thought would be beneficial?
`13 A. None. Absolutely not. This is about
`14 delivering devices to an intended spot. And the
`15 challenge with the over-the-wire technique is we did not
`16 have standard technology, certainly in the United States;
`17 but it's cumbersome, it requires a couple of operators,
`18 and it becomes technically disabling and in many regards.
`19 Yes, it will give you back-up support. No, back-up
`20 support isn't the only thing a physician considers during
`21 a case. It's safety effectiveness and it -- sometimes
`22 these compromises weren't good compromises.
`23 Q. Okay. But I'm not sure if you answered my
`24 question or not. My question was --
`25 A. Ask again clearly then, please, and I'll try my
`
`1 A. But I mean, we're also doing this in the
`2 worst -- in the worst cases. I mean at this time this is
`3 not common place, this was boutique solution, creative
`4 solution to try to solve a complex dilemma. So it's --
`5 this isn't your average -- kind of not your average
`6 patient or average circumstance prior to 2006.
`7 Q. Got it. And I know you just said it was a long
`8 time ago.
`9 But do you happen to recall what the
`10 dimensions, what the sizes were for the full-length
`11 mother catheter and child catheter?
`12 A. Depends. The full-length portion of it would
`13 have been 6 or 7 French. You know, French being
`14 effectively a couple of millimeters at least in terms of
`15 internal diameter.
`16 A few variables here. One is there is --
`17 the mother catheter will need to be larger than the child
`18 catheter in order for the smaller one to fit into the
`19 large one. So it not only needs to be longer; it needs
`20 to be a little bit smaller for the fits to work.
`21 And at that point in time, you're also
`22 dealing with -- there was certa