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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
` LORENZO AZZALINI, M.D.
`DATE: December 7, 2020
`TIME: 1:02 p.m.
`PLACE: Richmond, Virginia
`(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-1820
`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
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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: We are going on the
`3 record at 1:02 p.m. on December 7, 2020. This is media
`4 unit 1 of the video-recorded deposition of Dr. Lorenzo
`5 Azzalini being taken via Zoom, and taken by counsel for
`6 the Petitioner in the matter of Medtronic, Incorporated
`7 and Medtronic Vascular, Incorporated versus Teleflex
`8 Innovations S.A.R.L., in the United States Patent and
`9 Trademark Office before the Patent Trial and Appeal
`10 Board. Case Number IPR2020-00126.
`11 My name is Adam Wallin from the firm
`12 Veritext, and I am the videographer. The court reporter
`13 is Dawn Bounds from the firm Veritext.
`14 Will counsel please identify themselves
`15 for the record.
`16 MR. MORTON: This is Cyrus Morton of
`17 Robins Kaplan on behalf of Petitioner Medtronic. Also
`18 with me on the deposition is William Manske.
`19 MR. RINN: This is Alex Rinn on behalf of
`20 patent owner with the Carlson Caspers firm. Also with me
`21 today from Carlson Caspers are Derek Vandenburgh and Joe
`22 Winkels, and Greg Smock is on the line from Teleflex.
`23 THE VIDEOGRAPHER: Will the court reporter
`24 please swear in the witness, and we can proceed.
`25 THE REPORTER: Due to the need for this
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`1 deposition to take place remotely because of the
`2 government's order for physical distancing, the parties
`3 will stipulate that the court reporter may swear in the
`4 witness over the videoconference and that the witness has
`5 verified that he is in fact Lorenzo Azzalini.
`6 Agreed, counsel?
`7 MR. RINN: Agreed.
`8 MR. MORTON: Agreed.
`9 LORENZO AZZALINI, M.D.,
`10 duly sworn via videoconference as stipulated by counsel
`11 was examined and testified as follows:
`12 EXAMINATION
`13 BY MR. MORTON:
`14 Q. Good afternoon, Dr. Azzalini.
`15 Have you had your deposition taken
`16 before?
`17 A. This is the first time I have my deposition
`18 here with me, yeah.
`19 Q. Okay. You've never had your deposition taken
`20 before in any other matter?
`21 A. No, no. That's the first time.
`22 Q. Okay. Did you have time to prepare for this
`23 deposition with counsel?
`24 A. Yes, I reviewed my declaration.
`25 Q. Okay. But were you prepared for the deposition
`
`1 I N D E X
`2 WITNESS: LORENZO AZZALINI, M.D. PAGE
`3 EXAMINATION BY MR. MORTON.......................... 5
`4 EXAMINATION BY MR. RINN............................ 36
`5 EXHIBITS PREVIOUSLY MARKED/REFERRED TO
`6 No. 2151: Declaration of Dr. Lorenzo Azzalini..... 20
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`1 with counsel; either Mr. Rinn, Mr. Winkels, did you spend
`2 time with them to prepare for your deposition?
`3 A. Yeah, I spent -- I spent a few hours with them.
`4 Q. Okay. So as you can see, it's a deposition. I
`5 ask the questions. You give the answers.
`6 I want to make sure, since it's a Zoom
`7 deposition, can you hear my questions appropriately?
`8 A. Yes, I can.
`9 Q. And as you sit there, can you think of any
`10 reason why you would not be able to give truthful and
`11 accurate responses to my questions this afternoon?
`12 A. No.
`13 Q. When did you begin practicing?
`14 A. So I finished training in 2013 as a
`15 cardiologist, and then I started an interventional
`16 cardiology fellowship between '13 and '15. And then I
`17 spent the last five years as a practicing interventional
`18 cardiologist.
`19 Q. Okay. So since you've been training and
`20 practicing, there have always been GuideLiners; is that
`21 fair?
`22 A. That's correct, yes.
`23 Q. Always been some form of a rapid exchange
`24 version of a guide extension catheter, right?
`25 A. Yes, I've mainly been exposed to GuideLiner.
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`Page 8
`1 experience with GuideLiner, so usually one tries to use
`2 what he or she is more used to.
`3 But other than that, since I've used the
`4 other two devices so few times, I cannot really make a
`5 scientific opinion whether one is better than the other
`6 or vice versa.
`7 Q. All right. And have you -- have you used all
`8 three versions of GuideLiner?
`9 A. No. I think I just used the V3, the latest
`10 one.
`11 Q. Okay. You never had a chance to - even in your
`12 studies or training - work with or use GuideLiner
`13 versions 1 or 2?
`14 A. I don't think so.
`15 It might be that GuideLiner Version 1
`16 never made it to Europe for sure when I started using it.
`17 I think that -- I'm pretty sure I just used V3.
`18 Q. So these products all have what we call a "side
`19 opening" in this case, a proximal opening, into the
`20 distal tubular structure.
`21 You're familiar with that?
`22 A. Yeah. So are you referring to the half-pipe or
`23 collar or the end?
`24 Q. Yes; no, that's the end where you kind of go
`25 from a pushrod or a push wire, you have some kind of a
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`1 Q. Okay. And have you ever used Guidezilla or
`2 Telescope?
`3 A. Yes. Guidezilla probably around 10 times or a
`4 dozen times, and Telescope just, I think, once.
`5 Q. Okay. So obviously you've used GuideLiner more
`6 often.
`7 But now that you've looked at the other
`8 two, do you have -- do you have a favorite or any reason
`9 why you'd use one versus the other?
`10 A. So I think mainly in most places I've worked,
`11 the main guide catheter extension was a -- was
`12 GuideLiner. So part of the reason why I use more --
`13 actually, most of the reason why I use more GuideLiner is
`14 because the cath lab where I worked had that on the
`15 shelf.
`16 And I also think that Telescope came quite
`17 later than the other two products on the market.
`18 Q. Sure. And I'm just asking -- you know, assume
`19 that on the shelf is a -- is GuideLiner, Guidezilla, and
`20 Telescope, they're all on the shelf.
`21 Other than just kind of your familiarity
`22 with GuideLiner, do you have any reason why you'd pick
`23 one over the other in terms of their structure or
`24 function?
`25 A. Well, as you mentioned, I have much more
`
`1 half-pipe -- whatever you've got -- opening into the
`2 tube, that section there. From a patent standpoint,
`3 we've been calling that a side opening.
`4 A. Okay.
`5 Q. But it's just the proximal opening into the
`6 distal tube. So that section, okay?
`7 A. Okay.
`8 Q. In the time that you have spent with Version 3
`9 and Guidezilla - and I think you said you used Telescope
`10 once - do you have any preference, any clinical
`11 difference in terms of that part of the device, between
`12 one device and another?
`13 A. So my understanding is that both Telescope and
`14 GuideLiner, that half-pipe is made of -- so it's like a
`15 plastic like material, where Guidezilla is made of a
`16 metallic compound.
`17 So as mentioned, since I haven't used the
`18 other two devices much and I 99.9 percent have used the
`19 GuideLiner, I cannot make a -- like a recommendation or
`20 like an opinion whether polymer or metal is better.
`21 Q. Okay. Do you have any other differentiating
`22 factor, from just a clinical standpoint, between the
`23 different materials used, polymer and metal, that you
`24 think about?
`25 A. So I'm not an engineer, so this is the only one
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`1 that I can think of, honestly.
`2 Q. Okay. Okay. Thanks.
`3 So in the time you've been performing
`4 procedures, have you experienced a situation where you're
`5 just using a guide catheter, and it backs out of the
`6 coronary ostium?
`7 A. Yes. It's pretty common, unfortunately.
`8 THE REPORTER: I'm sorry, Doctor. Repeat
`9 what you're saying.
`10 A. Yes, unfortunately it is a pretty common
`11 occurrence.
`12 BY MR. MORTON:
`13 Q. Okay. And when that has happened, you need
`14 to -- obviously you need to do something to address that
`15 situation, right?
`16 A. Uh-huh.
`17 Q. Have you ever responded to that by trying to
`18 deep-seat just the guide catheter further into the
`19 coronary artery?
`20 A. Yes, that's a -- one possibility. It's
`21 actually probably the first thing you can think of.
`22 Q. Okay. And can you give me an idea of how often
`23 you've tried that and how successful it's been?
`24 A. So on probably every time that you have back --
`25 back-up support issues, you try to push the guide back
`
`1 the cases.
`2 On the right, every now and then. I would
`3 not say frequently.
`4 Q. Okay. How about -- another thing that I've
`5 heard that you can do is swap out and use a completely
`6 different guide catheter. It may have different
`7 materials, different bend to it.
`8 Is that something that you've done in your
`9 practice?
`10 A. Yes. So that's a feasible option if you
`11 realize from the very beginning that you're having
`12 trouble and you think that there is a better catheter --
`13 when I say better, I mean a different shape -- that
`14 better fits into that coronary.
`15 Once you started with procedure and you
`16 started wiring and ballooning and stenting, it's really
`17 not an option; because you would have to sacrifice your
`18 wire position, and that is -- comes with consequences and
`19 risks.
`20 So if the vessel is dissected, it's not
`21 wise and safer for the patient to change the guide
`22 because this would imply removing everything.
`23 Q. Got it.
`24 So can you just focus your answer just on
`25 when it is a feasible option and tell me what that is?
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`Page 11
`1 in. Then you can go further than that and actually try
`2 to deep-seat the guide catheter inside the coronary
`3 artery.
`4 So are you referring to that?
`5 Q. Yes.
`6 A. So these maneuvers, I tried it in the past, and
`7 I still sometimes try it. It's quite laborious, I would
`8 say. It can -- I usually use it only on the right
`9 coronary artery because it's -- there are no major
`10 branches, as opposed to the left coronary artery.
`11 You have to be very delicate because the
`12 guide catheter is pretty big and can be also stiff. So
`13 you can create some damage on the -- on the artery walls.
`14 So usually you cannot advance a lot inside a coronary
`15 artery.
`16 Having said that, it's successful
`17 sometimes; but I would say in the minority of cases.
`18 Q. Okay. So it's something you would commonly
`19 try, but in a minority of cases, it would -- it's
`20 successful; is that right?
`21 A. Exact -- in the minority of cases, it would be
`22 successful. I do not try very often, first of all, as I
`23 mentioned, because on the left coronary, it's dangerous.
`24 So already more than 50 percent of the cases I do not do
`25 it because that left coronary is more than 50 percent of
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`1 A. It would be feasible, I would say only -- for
`2 example, you take the diagnostic picture and -- with the
`3 guide catheter, and you immediately realize that there's
`4 no way you can accomplish that procedure because you've
`5 made a poor guide catheter choice, and that must happen
`6 very early in the procedure.
`7 If you start wiring and ballooning,
`8 usually it's not a safe thing to do.
`9 Q. Got it.
`10 How about another thing that I've heard
`11 you can do is -- it may be in your declaration -- is to
`12 use a buddy wire.
`13 Are you familiar with that?
`14 A. Yes. I am familiar with that, yes.
`15 Q. And is that something that you've done in your
`16 career to address a problem of a guide catheter backing
`17 up?
`18 A. Yes. It's something that I try, for example,
`19 more often than deep-seating, even nowadays.
`20 Actually, many times I might go to tech --
`21 first line technique when I have back-up support issues.
`22 Because maybe you already have another wire on the table,
`23 and you can just insert it. It -- it creates a rail onto
`24 which the other device - the balloon or stent - can go,
`25 and it's sometimes successful, yes.
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`1 Q. Okay. Can you give me any idea sort of what
`2 percentage of cases you would attempt a buddy wire, and
`3 it would be successful?
`4 A. So let's say that in -- in a case that I have
`5 support issues, I would try that probably 40, 50 percent
`6 of the times and not in all -- in all the times; not
`7 always, because there are some cases that, you know,
`8 already from the beginning that there is no way the buddy
`9 wire technique can work.
`10 Also, because sometimes the lesion you're
`11 trying to -- to bring balloons to is -- is just so tight,
`12 so narrow, that it's almost impossible that you're going
`13 to be able to cross with a second wire; and you can run
`14 the risk of dissecting, so damaging the vessel.
`15 But other than that, yeah, I would say
`16 maybe 40 -- maybe 45 percent of the time, I would try
`17 that.
`18 Q. Okay. And in the cases when you tried it, how
`19 often is it successful?
`20 A. Of that 40 to 45 percent, it might be
`21 successful in 30 percent.
`22 So if we make that 45 percent 100 now, it
`23 would be successful in 30 percent.
`24 Q. Okay. So, ultimately, 30 percent out of 100
`25 percent successful with the buddy wire?
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`1 MR. RINN: Objection, form.
`2 A. 30 percent of the 45 -- of the 45 percent of
`3 the time where I would try the buddy wire, so it's --
`4 it's way less than that.
`5 BY MR. MORTON:
`6 Q. Okay. I was just trying to figure out where
`7 it -- where it falls.
`8 So 40 to 45 percent of the time, you try
`9 the buddy wire, and 30 percent of those times, it's
`10 successful?
`11 A. Yeah. I would say basically over -- a total
`12 absolutely, in absolute terms of 100, I would say 15
`13 percent, it's successful.
`14 Q. Okay.
`15 A. Okay. To make it clear.
`16 Q. So how about another option, which would be
`17 a -- what I'll call a full-length mother-and-child with a
`18 full-length child catheter; is that something that you're
`19 familiar with?
`20 A. I know pretty well what you're talking about.
`21 I've used that technique -- not for
`22 interventional purposes, so not to do like a -- with a
`23 balloon or a stent; whereas, sometimes -- pretty rarely,
`24 though, to -- in -- for diagnostic angiograms, sometimes
`25 the catheter would not reach, and I would use a smaller
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`Page 16
`1 catheter inside the main catheter to reach the coronary.
`2 But not for interventional purposes,
`3 because, as I mentioned before, since I started
`4 practicing, the GuideLiner and then the Guidezilla and
`5 Telescope were already available.
`6 Q. Sure. Understand that.
`7 So if we focus again on the time that you
`8 did use it, if I understand, you've used a full-length
`9 mother-and-child system where you've extended the child
`10 catheter further into the coronary vasculature, you just
`11 did that only for diagnostic; is that right?
`12 A. Yes. Let me specify.
`13 So basically sometimes the ostia is very
`14 dilated. You need the cath -- you have a catheter that
`15 points toward the coronary ostia, but you cannot reach
`16 it; so you put a smaller catheter inside.
`17 So you're not actually going into the
`18 coronary artery with the child, but just onto the
`19 beginning of it, so the ostium.
`20 Q. All right. Have you ever -- have you ever
`21 witnessed what I'll call a full-length mother-and-child
`22 being used for the purpose of actually delivering a
`23 device, like a balloon or stent?
`24 A. So I think I might have seen presentations from
`25 the past, but even my teachers and mentors that I had the
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`Page 17
`1 privilege of working with that are pretty reknown in the
`2 field, they quickly converted to the guide catheter
`3 extension - initially the GuideLiner, then Guidezilla,
`4 and Telescope - when I was in practice. So I just know
`5 the information from the past.
`6 Q. Okay. So basically once there was a rapid
`7 exchange version of mother-and-child, everybody used
`8 that; is that fair?
`9 A. I don't know the exact nomenclature of -- how
`10 you want to frame the guide catheter extension; but I
`11 would just call it guide catheter extension.
`12 Q. So these things that we've discussed, we
`13 discussed deep-seating, using a different guide catheter,
`14 and the buddy wire.
`15 So are these all -- are all three of those
`16 things, things that you would potentially try first; and
`17 then if they didn't work, then you would try a guide
`18 extension catheter?
`19 A. Not all the times.
`20 So with -- you know, with experience, it
`21 comes -- sometimes you get to a point to where from the
`22 get-go, you understand a buddy wire would not work.
`23 Or you cannot, for example, change to a
`24 bigger or different guide catheter if you're going from
`25 radial axis because you're already using a big catheter,
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`1 so you cannot change it.
`2 So in a real-life and real-world practice,
`3 sometimes I would choose the buddy wire technique; and if
`4 it doesn't work, I would go for a guide catheter
`5 extension.
`6 Some other times I will go straight for
`7 the guide catheter extension because it's also a matter
`8 of, you know, efficiency in the cath lab.
`9 So you don't want to necessarily use all
`10 techniques available and described in the literature.
`11 You want to get the job done pretty quickly to move on to
`12 the next patient, also to decrease the risk for the
`13 patient you have on the table.
`14 You don't want to try 20 techniques when
`15 you know that there is something that just works.
`16 Q. Got it.
`17 So if I could break that down a little.
`18 I could understand if when you're planning
`19 for the procedure and you already figure out that you're
`20 going to need a guide extension catheter, that's one
`21 situation, right?
`22 A. That's one possible situation, yes.
`23 Q. And then let's look at the -- well, how often
`24 is that, just as long as we're on that topic?
`25 Like how often do you know before you even
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`1 try those. But if I see that immediately after exiting
`2 the guide catheter, the stent got trapped in some plaque,
`3 I would have to deliver that stent very distant -- very
`4 distal from -- from the guide catheter.
`5 I'd say, you know, there is no way
`6 deep-seating with a guide catheter or using a buddy wire
`7 is going to work. And in the past, I've tried it also
`8 because sometimes there are financial restrictions, and
`9 these devices, these guide catheter extensions are
`10 expensive.
`11 So I would try those techniques; but
`12 inevitably if you have to cover a large distance with
`13 your stent and you have problems from very beginning, I
`14 think you should switch to a guide catheter extension.
`15 Q. So in your -- do you have your declaration
`16 available?
`17 A. Yes, I do.
`18 Q. Okay. So starting in paragraph 6 of your
`19 declaration.
`20 A. Yes.
`21 Q. You're talking about what you call a
`22 full-length, over-the-wire catheter inside a guide
`23 catheter, or what is known as a mother-and-child
`24 configuration.
`25 Do you see that?
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`1 start, I'm going to have to use a guide extension
`2 catheter?
`3 A. Not more than 40 percent, probably. I would
`4 say the majority of cases, you just find out during the
`5 procedure, because many times it's just an expected.
`6 Q. Okay. So if you find out during the procedure,
`7 in the other 60 percent of cases, roughly, then are these
`8 changes in the guide catheter, deep-seating the guide
`9 catheter, and buddy wire, are those typically things that
`10 you would try first; and if those fail, then you try a
`11 guide extension catheter?
`12 A. So changing guide catheter halfway through a
`13 procedure, I'd say is not the best thing; so I would
`14 almost never do that. At least I will try not to do it.
`15 Then deep-seating and buddy wire -- buddy
`16 wire, I will try, yeah, as I mentioned, more often than
`17 deep-seating the guide; because, as I mentioned,
`18 deep-seating is just feasible for the right coronary
`19 artery.
`20 But I would say that both deep-seating the
`21 guide and buddy wire sometimes work when the distance
`22 that you have to reach, you know, from the point you got
`23 stuck with your balloon or stent is not very long.
`24 So if I have to gain an additional 10,
`25 maximum 15 millimeters with my balloon or stent, I will
`
`1 A. Yes.
`2 Q. And then, I mean, you go through here and that
`3 paragraph and the next couple paragraphs -- well, strike
`4 that. Let me start over.
`5 And you contrast that full-length
`6 mother-and-child about halfway down the paragraph and
`7 talk about a rapid exchange length guide extension
`8 catheter. Do you see that?
`9 A. A rapid exchange length guidewire.
`10 Q. Oh, yeah; that's right. You're right. Just
`11 trying to get set up so I can ask you some questions.
`12 All right. Let me just focus on the
`13 full-length mother-and-child --
`14 A. Yes.
`15 Q. -- that you talk about here.
`16 A. Yeah.
`17 Q. You give some of the drawbacks of that here in
`18 the next couple paragraphs, right?
`19 A. Yes.
`20 Q. Okay. And just for the record, if you could
`21 just list as succinctly as possible, what are drawbacks
`22 of the full-length mother-and-child configuration?
`23 A. So first of all, you need -- my understanding
`24 is that you need -- the smaller guide catheter that you
`25 put in should be 2 French smaller. Okay?
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`1 So if you're doing a procedure -- and most
`2 procedures -- I would say 70, 80 percent, if not more --
`3 and some people just use this size of 6 French. Okay?
`4 6 French guide catheter would require a 4
`5 French child to mother-and-child. And although these
`6 guide catheters exist, they are not common. And most
`7 interventional devices that we use in adults at least are
`8 not 4 French compatible; particularly the stents, they
`9 require 5 French.
`10 So unless you're starting with a 7 French
`11 guide, you cannot do a mother-and-child during the
`12 procedure. You would have to switch and remove the guide
`13 catheter, start with a bigger one.
`14 So that said, that is already a no-go, if
`15 you've already started manipulating the -- the lesion.
`16 So this is one.
`17 Second, the problem with that is that you
`18 need a long wire, so longer than the rapid exchange
`19 guidewire, which is usually 190 centimeters. So you
`20 would need an exchange length wire that is usually around
`21 300 centimeters.
`22 So if you've already wired the lesion and
`23 manipulated it, you would have to pull out that wire and
`24 insert a longer wire or use a guidewire extension. That
`25 is also a possibility.
`
`1 A. Yes.
`2 Q. So that difference, going from full-length to
`3 what I think of as a rapid exchange version, but -- you
`4 understand what I'm talking about?
`5 A. Yes, I do.
`6 Q. Okay. So when you -- if you make that change,
`7 you no longer need -- I'm going to go backwards through
`8 your issues -- you would no longer need a more rigid
`9 child catheter; is that right?
`10 A. Yes. Usually they're more -- they are softer,
`11 yeah.
`12 Q. Right.
`13 And that's because they don't have to --
`14 they basically don't have to push as far?
`15 A. I guess that it's also -- I'm not an engineer,
`16 but I guess also it's the material issues. I mean,
`17 they're -- they made these extensions more flimsy to be
`18 able to navigate through --
`19 THE REPORTER: "To be able to navigate,"
`20 what? I'm sorry.
`21 A. To be able to navigate through the coronary
`22 arteries more easily. They are softer, so they're less
`23 aggressive, and they have lower risk of damaging the
`24 artery.
`25 BY MR. MORTON:
`
`Page 23
`
`1 The problem with that is that it requires
`2 two operators; and, you know, there are two sets of hands
`3 and two brains that have to be coordinated. And in
`4 practice, even being very attentive, I've noticed that it
`5 is not -- it does not go as smoothly as it usually -- it
`6 is expected to be.
`7 And so you might lose the guidewire
`8 position because of some slacking -- this very long
`9 system. So these are the main drawbacks.
`10 And also another drawback is that usually
`11 these guide catheters are more rigid than guide catheter
`12 extensions, so they do not offer the same performance
`13 going down the coronary artery as opposed to a guide
`14 cath -- a real guide catheter extension.
`15 Q. Okay. So then I want to talk about moving from
`16 full-length mother-and-child to what I think of as rapid
`17 exchange, but the shorter distal tube guide extension
`18 catheter. Okay?
`19 You understand what we're going to do
`20 here? We're going to move from one to the other?
`21 A. From mother-and-child full-length to guide
`22 catheter extensions, yes.
`23 Q. Yes. So -- and I mean -- and I want to focus
`24 just on the change being you have a shorter distal tube
`25 and a push wire leading up to that.
`
`Page 25
`1 Q. And you can do that because you have a short
`2 distal tube instead of a full-length child, right?
`3 A. Yeah. You -- I mean, you can do that, not --
`4 not specifically because it's a shorter tube, but it's
`5 because it's a -- it's more gentle on the artery, I
`6 think. That's the central point.
`7 That's why you can push them -- be more
`8 confident that it's going to go where you want them to go
`9 without damaging the -- the artery.
`10 Q. I see. So basically just if it's designed to
`11 go deeper into the vasculature, you're going to use a
`12 softer material?
`13 A. Yes.
`14 Q. Okay. Another thing that you mentioned was the
`15 need for two operators.
`16 So again, that issue is resolved just by
`17 going from full-length mother-and-child to shorter distal
`18 tube rapid exchange version, right?
`19 A. Correct.
`20 Q. Then the next thing you mentioned was the
`21 length of the wire, meaning a 300-centimeter wire. Same
`22 question: When you make that move we're talking about to
`23 the shorter distal tube, that issue is resolved, right?
`24 A. Exactly. Those are all benefits of guide
`25 catheter extensions.
`
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`
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`
`7 (Pages 22 - 25)
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`Page 26
`1 Q. And then the other thing you mentioned with the
`2 full-length mother-and-child was the need for a 2 French
`3 differential, 4 in 6.
`4 Do you recall that?
`5 A. Yes.
`6 Q. And that issue is also resolved as soon as you
`7 move to a rapid exchange version like we've been
`8 discussing?
`9 A. Yes, exactly.
`10 Q. And is that because of a pushability, or what
`11 is the -- what is the reason why you need a 2 French
`12 differential for a mother-and-child?
`13 A. My understanding is because the -- the wall of
`14 the child is much thicker than the wall of a guide
`15 catheter extension.
`16 And so if you just go with a -- if they go
`17 with the same size, it will never enter -- the child will
`18 never enter the mother.
`19 If you just go with one French smaller, it
`20 will still not go because of the thickness of the child
`21 wall is -- is still relevant. So you need 2 French
`22 smaller usually.
`23 Q. Okay. So that is maybe from a clinical
`24 standpoint what's available on the shelf.
`25 But if you were designing a full-length
`
`Page 27
`1 child catheter to go into the vasculature, wouldn't you
`2 just make it thinner?
`3 A. I'm not an engineer.
`4 So, also, there are issues, you know, to
`5 be taken into consideration. You cannot make something
`6 too thin; otherwise, it might collapse and might not be
`7 able to have enough -- enough pushability.
`8 So, you know, I'm really not an engineer,
`9 so I'm not sure I can provide a -- like a meaningful
`10 answer here.
`11 Q. Okay. Do you -- and I -- I appreciate that.
`12 But do you think part of the issue is if
`13 you make a shorter distal tubular section, that makes it
`14 easier to use thinner materials because you only have to
`15 have it stay structurally stable over a shorter period?
`16 MR. RINN: Objection, foundation; form.
`17 A. I don't think that the thickness of the
`18 material has to do with the length that they have to be
`19 exposed into the coronary.
`20 I think it's a matter of compatibility
`21 with the existing guide catheter. But, again, I'm not an
`22 engineer, so I'm not sure.
`23 BY MR. MORTON:
`24 Q. Okay. So as far as you know, this -- this
`25 issue, again, is resolved from the move -- from pulling
`
`Page 28
`1 mother-and-child to rapid exchange GuideLiner-type
`2 version we've been talking about?
`3 A. Yes. I would say that the guide catheter
`4 extension is very relevant, advanced in the
`5 interventional field of interventional cardiology,
`6 and it's much better that the mother-and-child.
`7 Q. Right. But I'm just asking, as far as you
`8 know, once you go to a shorter distal tubular sect