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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)
`IPR2020-00134 (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
` DR. JOHN J. GRAHAM, MB ChB, MRCP (UK)
`
`DATE: November 18, 2020
`TIME: 6:42 a.m. (EST)
`PLACE: Toronto, Ontario, Canada
`(via videoconference)
`JOB NO.: MW 4338252
`
`REPORTED BY: Dawn Workman Bounds, CSR
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`1 A P P E A R A N C E S
`2 (ALL APPEARANCES ARE VIA VIDEOCONFERENCE)
`3 ON BEHALF OF PETITIONERS:
`4 CHRISTOPHER PINAHS, ESQ.
` CYRUS A. MORTON, ESQ.
`5 ROBINS KAPLAN LLP
` 2800 LaSalle Plaza
`6 800 LaSalle Ave
` Minneapolis, MN 55401
`7 612.349.8500
` cpinahs@robinskaplan.com
`8 camorton@rkmc.com
`9
`10 ON BEHALF OF PATENT OWNER:
`11 JOSEPH W. WINKELS, ESQ.
` PETER KOHLHEPP, ESQ.
`12 DEREK VANDENBURGH, ESQ.
` CARLSON CASPERS VANDENBURGH & LINDQUIST, PA.
`13 Capella Tower, Suite 4200
` 225 South Sixth Street
`14 Minneapolis, MN 55402
` 612.436.9623
`15 jwinkels@carlsoncaspers.com
` pkohlhepp@carlsoncaspers.com
`16 dvandenburgh@carlsoncaspers.com
`17 ALSO PRESENT:
`18 Greg Smock
` Chris Buller
`19 DeAndre Shivers, Videographer
`20
`21
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`25
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`1 P R O C E E D I N G S
`2 THE VIDEOGRAPHER: This is the beginning
`3 of the videotaped deposition of Dr. John Graham in the
`4 matter of Medtronic versus Teleflex Innovations. Today's
`5 date is November 18, 2020, and the time is 6:42 a.m.
`6 Counsel, please introduce yourselves,
`7 after which our court reporter will make a statement and
`8 swear in the witness.
`9 MR. PINAHS: Good morning. This is Chris
`10 Pinahs from the Robins Kaplan law firm on behalf of the
`11 Petitioner, Medtronic. Also with me this morning is my
`12 colleague Cy Morton from the Robins Kaplan law firm as
`13 well.
`14 MR. WINKELS: Here on behalf of the patent
`15 owner, Joe Winkels with Carlson Caspers; and with me is
`16 Peter Kohlhepp; and Derek Vandenburgh will be joining a
`17 little bit later.
`18 THE REPORTER: Due to the need for this
`19 deposition to take place remotely because of the
`20 government's order for physical distancing, the parties
`21 will stipulate that the court reporter may swear in the
`22 witness over the videoconference and that the witness has
`23 verified that he is in fact Dr. John Graham.
`24 Agreed, counsel?
`25 MR. PINAHS: So stipulated for petitioner.
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`Page 3
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`1 I N D E X
`2 WITNESS: DR. JOHN GRAHAM, MB ChB, MRCP (UK) PAGE
`3 EXAMINATION BY MR. PINAHS.......................... 5
`4 EXAMINATION BY MR. WINKELS......................... 163
`5 EXAMINATION BY MR. PINAHS.......................... 178
`6 EXAMINATION BY MR. WINKELS......................... 179
`7
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`EXHIBITS MARKED/REFERRED TO
`
`No. 1001: Patent No. RE45,380 E................... 93
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`No. 1005: Brecker Declaration..................... 155
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`No. 1007: Patent No. 7,736,355 B2................. 173
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`No. 1008: Patent No. 7,604,612 B2................. 173
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`No. 2145: Graham Declaration...................... 7
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`Page 5
`1 MR. WINKELS: The patent owner agrees as
`2 well.
`3 JOHN GRAHAM,
`4 duly sworn via videoconference as stipulated by counsel
`5 was examined and testified as follows:
`6 EXAMINATION
`7 BY MR. PINAHS:
`8 Q. Good morning, Dr. Graham.
`9 A. Good morning.
`10 Q. Can you just state your name and work address
`11 for the record, please.
`12 A. My name is John Graham. I work at St.
`13 Michael's Hospital in the division of cardiology, 30 Bond
`14 Street, Toronto, Ontario, Canada.
`15 Q. Dr. Graham, have you been deposed before?
`16 A. This is my first time.
`17 Q. First time. All right. Great. Let's go over
`18 a couple ground rules then since it's your first time.
`19 It's particularly important, especially
`20 given the circumstances of a deposition over Zoom, if you
`21 give verbal answers today. Can you do that?
`22 A. Yes.
`23 Q. And I'm going to try to ask as straightforward
`24 questions as possible; but if for any reason you don't
`25 understand, I just ask that you ask for clarification of
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`1 my question.
`2 A. Understood.
`3 Q. From time to time your counsel may object to a
`4 question I ask. Unless he instructs you not to answer
`5 for reasons of privilege, you can answer the question
`6 after the objection.
`7 Do you understand?
`8 A. I understand.
`9 Q. If at any point you want to take a break, more
`10 than happy to do so.
`11 Only thing I ask is that you answer any
`12 pending questions before we go off the record. Okay?
`13 A. I understand.
`14 Q. Is there any reason you can't give truthful and
`15 honest answers today, Doctor?
`16 A. No. My intention is to speak the truth.
`17 Q. All right. And you've been retained by the
`18 patent owner Teleflex as an expert in these IPRs,
`19 correct?
`20 A. That is correct.
`21 Q. And when were you retained by the patent owner?
`22 A. Earlier on this year. I -- I have the
`23 information. It -- the springtime is -- is roughly when;
`24 March or April, I believe. I can confirm, but I would
`25 have to...
`
`1 A. Other than counsel, so Carlson Caspers.
`2 Q. In preparing your declaration, did you review
`3 any materials other than those cited in the declaration?
`4 A. Yes.
`5 Q. Okay. What were those materials?
`6 A. There were various things.
`7 So when I was writing my declaration and
`8 subsequent to it, we had submitted some references, some
`9 academic papers; and in the context of that, there was a
`10 lot of manuscript and journal searching just to --
`11 because this is a -- almost a -- not quite historic, but
`12 there's a lot things -- a lot of the alleged prior art
`13 relates back to the '90s and early 2000s.
`14 So I had gone back to do a literature
`15 review to refresh my memory and go back to things;
`16 because in the early '90s, I wasn't practicing. So I had
`17 to go back then to just refresh my memory and see what
`18 other practice was employed at that time.
`19 Q. So it sounds like you did a literature search.
`20 Anything else that you reviewed in
`21 preparation of preparing your declaration other than the
`22 literature search and what's cited in your declaration?
`23 A. And there were also -- so the -- Medtronic and
`24 Teleflex have on their websites, they have a lot of
`25 product brochures, so I -- various things, for example,
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`Page 7
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`Page 9
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`1 Q. March or April of 2020, Doctor?
`2 A. 2020.
`3 Q. All right. Thank you.
`4 All right. So it sounds as though you've
`5 already opened up the box of documents we sent you,
`6 correct?
`7 A. I did, yes.
`8 Q. And you opened those yesterday?
`9 A. Yesterday afternoon when they arrived, yes.
`10 Q. Okay. So what I'd like you to do is pull out
`11 Exhibit 2145, which is your declaration in this case.
`12 A. I have it.
`13 Q. Excellent. Now, Doctor, did you write your
`14 declaration?
`15 A. It is my words in it. I put my thoughts down,
`16 and myself -- and Carlson Caspers helped me write it, but
`17 it's my words.
`18 Q. And other than the attorneys, which it sounds
`19 like wrote the declaration, did you discuss the content
`20 of your declaration with anyone else?
`21 A. No, not -- not with counsel.
`22 Q. Sorry, I didn't understand that, Doctor.
`23 Are you saying you didn't discuss the
`24 content of your declaration with anyone other than
`25 counsel?
`
`1 guide catheter internal dimensions.
`2 There -- I often worked in millimeters in
`3 the metric system, but it's often put in inches; so I
`4 often had to go on and just refresh my memory between the
`5 two of them. So I would say that academic literature
`6 review and on the -- the companies' websites to look at
`7 their product, I/F, the instruction for use manuals.
`8 Q. All right. So a literature search, product
`9 literature.
`10 Anything else?
`11 A. There may be others, but that's the main ones
`12 that I can recall just now.
`13 Q. Now, your declaration, Doctor, doesn't contain
`14 any experiments or tests that you performed, correct?
`15 A. Correct.
`16 Q. Did you perform any experiments or tests in
`17 preparation of your declaration?
`18 A. Could you be more specific?
`19 Q. Yeah, so it sounds like, if I understand your
`20 testimony correctly, Doctor, that you worked with the
`21 attorneys to draft your declaration; that you also
`22 performed a literature search; and looked at product
`23 literature on-line.
`24 Correct so far?
`25 A. That and my experience with using guide
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`1 extension catheters over the past 16, 17, 18 years.
`2 Q. Okay. I understand you're a practicing
`3 physician.
`4 So setting that experience aside, I just
`5 want to know whether you performed any tests as you were
`6 preparing your declaration?
`7 A. Not for the preparation of this, but I have
`8 performed experiments with guide catheter extensions, but
`9 I did not --
`10 Q. And those --
`11 A. I did not use that for the purposes of my
`12 declaration.
`13 Q. And the experiments you mentioned with guide
`14 catheters, was that performed in your capacity as a
`15 practicing physician or in the capacity of this
`16 litigation?
`17 A. Practicing physician. It was nothing to do
`18 with this litigation. It preceded it by a few years.
`19 Q. Doctor, how long did you spend preparing for
`20 today's deposition?
`21 A. Today's deposi -- do you mean the hours I've
`22 spent in total working on this?
`23 Q. We'll get to that -- we'll get to that question
`24 in just a second, Doctor.
`25 I just want to know, let's say, over the
`
`1 spent in this case or retained for Teleflex on this
`2 matter?
`3 A. So I think -- and I know this -- I spent 68
`4 hours up until early October, and then in the past two to
`5 three weeks close to another 30 hours.
`6 Q. All right. Doctor, I'd like you to flip to
`7 your CV in your declaration. It's on page 144.
`8 And when I say page 144, I mean the pages
`9 in the lower left, the bolded numbers. We'll go off
`10 those today.
`11 A. I have it.
`12 Q. Great.
`13 So my first question, Doctor - given that
`14 I am not familiar with how medical school works in the
`15 U.K. - so in 1995 you got an MB ChB.
`16 Can you explain what that is?
`17 A. It's Latin. Medical bachelor, Chirurgiae
`18 bachelor. So it basically means a bachelor of medicine
`19 and a bachelor of surgery. The equivalent would be M.D.
`20 in North America.
`21 Q. All right. So I'm assuming then that you
`22 didn't do any PCI procedures during medical school,
`23 correct?
`24 A. Correct.
`25 Q. And just so that we're on the same page, what
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`Page 11
`1 last two weeks, how much time did you spend preparing for
`2 your deposition?
`3 A. In the last two weeks, I would imagine -- I
`4 can -- I'd have to look at my laptop, but it's probably
`5 close to 20, maybe even 30 hours.
`6 Q. And was anyone else involved with you in those
`7 preparations?
`8 A. So a lot of the reading and preparation was
`9 done at home on my own, and then I've had a few telephone
`10 calls with counsel.
`11 Q. Okay. And anyone other than counsel?
`12 A. The chief counsel for Teleflex was on one call,
`13 and I believe the chief medical officer.
`14 Q. All right. In preparing your deposition, did
`15 you review any materials other than those cited in this
`16 declaration.
`17 (Mr. Buller entered the videoconference.)
`18 A. Again, so I would have looked at product
`19 brochures just to refresh my memory, because I've read so
`20 much stuff; but essentially, mainly around the
`21 declaration.
`22 Q. All right. Doctor, you mentioned that you
`23 spent roughly 20 to 30 hours preparing for your
`24 deposition over the last two to three weeks.
`25 How many hours would you say, roughly, you
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`Page 13
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`1 is a PCI procedure?
`2 A. So PCI stands for percutaneous coronary
`3 intervention. Previously it was called PTCA, which is
`4 percutaneous transcutaneous or transluminal coronary
`5 angioplasty.
`6 And it involves -- there are many
`7 iterations that are done. Historically, a PCI was a
`8 plain old balloon angioplasty, POBA; and it was first
`9 described in 1977. The main issue with that was the
`10 higher rate of renarrowing, or restenosis; so the
`11 blockage would come back fairly quickly.
`12 And in 1988, the first man or first human
`13 stent implantation was described. And a stent is a
`14 metal -- oh, it's like a little spring or scaffolding
`15 that is on top of a balloon and is put in the artery; and
`16 when the balloon is withdrawn, the stent remains there.
`17 So currently a PCI procedure would usually
`18 involve balloon dilatation of an artery and subsequent
`19 stent implantation. There are various derivations of
`20 that where with more diffuse disease, a special balloon
`21 is used, a drug-coated balloon, rather than putting a
`22 stent in if the artery is not suitable for a stent. And
`23 sometimes other procedures, such as atherectomy a
`24 performed and occasionally no stent implanted.
`25 Q. So I have sometimes heard of PCI being formerly
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`1 known as angioplasty with a stent.
`2 Do you agree with that characterization?
`3 A. It is one characterization that is used, but
`4 the field has evolved. And in the field of complex PCI,
`5 often we have to use PCI with no stent, so a drug-coated
`6 balloon angioplasty. But angioplasty with a stent is --
`7 could be used.
`8 Q. All right. So it looks like your first stop
`9 after medical school was a JHO in medicine starting in
`10 August of 1995. Correct?
`11 A. Correct.
`12 Q. And what does JHO stand for?
`13 A. It stands for junior house officer. It's
`14 the -- it's the equivalent of an internship. It's where
`15 you get abused and have to work 120 hours a week for very
`16 little pay. It's the equivalent of an internship. And
`17 it's been -- thankfully it's been sort of made redundant.
`18 There's not a formal training.
`19 Q. So that's similar to what would be considered a
`20 residency in America?
`21 A. So the SHO is more akin to residency. It was
`22 more -- we called it "internship," where you really --
`23 you did everything for a year; six months of general
`24 medicine and six months of general surgery.
`25 Q. All right. So I'm assuming, then, that you
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`Page 15
`1 didn't perform any PCI procedures in either of your JHO
`2 positions?
`3 A. I did not perform PCI, but I looked after PCI
`4 patients, correct.
`5 Q. And did you -- you looked after PCI patients.
`6 Did you observe or watch PCI procedures in
`7 either of your JHO positions?
`8 A. I was expressing an interest in cardiology, and
`9 I did observe a few from afar, from the control room
`10 behind the screen.
`11 Q. All right. So I want to then move to the 1996
`12 to 1998 time period -- or 1999 period.
`13 What does SHO stand for?
`14 A. Senior house officer.
`15 And that is more akin to the residency
`16 program in North America.
`17 Q. And during either or any of your -- because you
`18 have three of them -- during any of your SHO stops, did
`19 you perform a PCI procedure?
`20 A. So I scrubbed in and did -- so in -- let me
`21 just go through this.
`22 In 19 -- August '96 to August '98, when I
`23 was in Glasgow, in Scotland, I witnessed a few, but did
`24 not participate in them. Between August '98 and February
`25 '99, when I was working as a resident, or an SHO, at
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`Page 16
`1 Brompton Hospital in London, I did scrub in for a few,
`2 purely as an assistant. And when I was working at
`3 cardiac intensive care at the Brompton, I did -- I did
`4 not do them then.
`5 Q. All right. So just to make sure I understand,
`6 Doctor. We've discussed up until August of 1999.
`7 And at this point you've observed a few
`8 PCI procedures, but have not yet performed your own PCI
`9 procedure, correct?
`10 A. I have not performed solo, but I have scrubbed
`11 in and assisted.
`12 Q. Maybe I can short-circuit this.
`13 When did you perform your first PCI
`14 procedure where you were in charge of it?
`15 A. That would be when I was -- October of 2000 --
`16 no, actually, I beg your pardon.
`17 It would have been when I was working at
`18 King George Hospital, Ilford. I used to go to the London
`19 Chest Hospital one day a week, and I performed PCI there.
`20 I was working -- I was a -- I did the
`21 procedure, but I was under the direct supervision of a
`22 staff cardiologist.
`23 Q. Do you remember, ballpark, in that yearlong
`24 residency, when you would have performed that first
`25 procedure?
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`Page 17
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`1 A. So I started in October. It
`2 would probably have -- it would have been -- not in the
`3 first couple of months. It would have been in the early
`4 months of 2002.
`5 Q. And during your time at King George Hospital,
`6 roughly, how many PCI procedures would you have
`7 performed?
`8 A. That -- between the early months of 2002 and
`9 September of that year, probably 20, maybe 30.
`10 This is dim memory, so I -- that may be an
`11 underestimate because it was a busy hospital.
`12 Q. And then at your next stop, which is St.
`13 Bartholomew, roughly, how many PCI procedures do you
`14 think you performed?
`15 A. A lot. 300.
`16 Q. All right. So when would you say you performed
`17 your first complex PCI procedure?
`18 A. Probably in St. Bartholomew's Hospital.
`19 Q. All right. So that would have been sometime
`20 between October of 2002 and March of 2005?
`21 A. Yes. So there were two hospitals in the
`22 rotation, London Chest and St. Bartholomew's. So
`23 unfortunately both of them -- actually, St. Bartholomew's
`24 is still in existence, but the Chest was subsumed into
`25 St. Bartholomew's; but we would spend either six months
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`1 or a year at each hospital, but they were the same
`2 organization, the same umbrella organization with two
`3 facilities.
`4 Q. All right. So I asked you about complex PCI,
`5 and I suppose we should probably unpack what that is.
`6 So what is the distinction between a
`7 routine PCI and a complex PCI?
`8 A. So I actually talk about this in my
`9 declaration, I think. And it's not just my opinion on
`10 this. There are -- the American College of Cardiology
`11 and the American Heart Association have got a
`12 classification of lesion complexity. So complex -- it's
`13 probably easier to talk about a simple PCI.
`14 So a simple PCI would be performed in a
`15 patient, usually a younger patient, with minimal comorbid
`16 features, i.e., they're otherwise young, fit, and
`17 healthy; and they have a single lesion in a proximal big
`18 coronary artery. And that lesion is short, not
`19 calcified, i.e., there is no mineral deposits of calcium
`20 around the wall of the artery, and there are no important
`21 side branches.
`22 You prefer to perform an angio -- side
`23 branch of an artery -- like a highway system, a side
`24 branch would be an exit off the highway. And the concern
`25 is that when you do an angioplasty, you can sometimes
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`Page 20
`1 causing a heart attack. So you would expect and hope
`2 that would not happen, but you are always prepared for
`3 that.
`4 But getting back to your question, the
`5 type A features, if you had the -- a few of the
`6 characteristics of type A lesion, then you would hope and
`7 expect it to be a more simple angioplasty.
`8 Q. What about for a type B, is that a routine or
`9 complex?
`10 A. So there are more features within a type B that
`11 takes it away from simple - to use your phrase - or
`12 routine. And the more of those features that you have
`13 would make it become more complex.
`14 Now, what we've learned in the 30 or so
`15 years since the ACC classification was published is that
`16 the angiographic analysis - and the classification
`17 depends on the angiographic analysis - that we are -- we
`18 are not as good as we thought at predicting
`19 calcification.
`20 So you may think the artery is minimally
`21 calcified, but you actually realize that it is quite
`22 extensively calcified. So the B is not simple, and is --
`23 B was more complex and can become complex.
`24 Q. And I assume that type C lesion is a complex
`25 procedure?
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`Page 19
`1 plow some of the plaque into the exit ramp and occlude
`2 that.
`3 So a simple angioplasty would be away from
`4 a big exit ramp, away from a side branch, and a proximal
`5 coronary artery, and it's relatively short.
`6 That's the simple description of a simple
`7 angioplasty. A complex angioplasty becomes more nuanced.
`8 I can refer to my declaration, or I can...
`9 Q. Well, let's do it this way, Doctor.
`10 So you mentioned that there is the
`11 American College of Cardiology has come up with a ranking
`12 system. Let's just take all three.
`13 An A type lesion, would that be a routine
`14 or a complex PCI?
`15 A. An A type lesion has features that would be --
`16 you would expect it to be a more routine angioplasty;
`17 however, they can become very complex. All -- there is a
`18 risk with all angioplasty, which could become very
`19 complex.
`20 Q. And how can it become complex?
`21 A. You're -- essentially you are ballooning an
`22 artery, and you are hoping that the artery opens up
`23 without dissecting. A dissection is a tear in the inner
`24 layer of the artery; and if that happens, it can extend
`25 all down the heart, the artery, and there is a risk of
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`Page 21
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`1 A. Dealing with type C lesions with features
`2 contained in type C categorizations, then you are
`3 expecting -- you're expecting to spend a bit of time
`4 trying to overcome this.
`5 Q. What do you mean by "you're expecting to spend
`6 a bit of time trying to overcome this"?
`7 A. So you're going to spend more time in
`8 preparation and thinking about it, so -- and this goes
`9 back to what I said in my declaration.
`10 There are various types of guide
`11 catheters, so you may use what we would classify a more
`12 aggressive supportive catheter and may have to use more
`13 than one wire for support. You may consider guide
`14 catheter extension. And you may have to prepare the
`15 artery for stent implantation in a more aggressive way.
`16 So that would involve debulking with
`17 rotational atherectomy, or using a laser in the artery,
`18 using special balloons with little razor blades on them,
`19 called cutting balloons, before you can get a stent in.
`20 So it just takes more time.
`21 Q. All right. So what I think I'm hearing you
`22 say -- well, actually, let me back up, Doctor.
`23 So it sounds like A is -- an A lesion is
`24 more of a routine kind of procedure, correct?
`25 A. You would expect it to be more routine.
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`1 Q. Okay. And the B category, you can't be
`2 certain. It could go either way, routine or complex?
`3 A. It's one way of putting it. I'm not sure
`4 if it's -- it's not unreasonable.
`5 I think that you could expect it with
`6 concentration; but it could become complex, yes.
`7 Q. And I think category C, you think it would be
`8 more likely to be complex?
`9 A. Correct. And you may be pleasantly surprised
`10 that it was relatively straightforward, but you would be
`11 expecting to be in there for some time.
`12 Q. All right. Okay. So in your declaration,
`13 Doctor, you mention that you performed, roughly, a
`14 thousand angioplasties between 2000 and 2005?
`15 A. Correct.
`16 Q. And I'd like to focus in on that time period.
`17 Of those thousand procedures, what
`18 percentage would you say used an over-the-wire balloon
`19 catheter?
`20 A. A small proportion. I would -- it would be
`21 probably 5 percent or less.
`22 Q. Again, just to make sure that I'm -- we're not
`23 talking past each other.
`24 If I -- I asked about an over-the-wire
`25 balloon catheter.
`
`1 second.
`2 What in -- was the typical profile of an
`3 over-the-wire balloon in the 2000 to 2005 time frame?
`4 A. I would have -- from the top of my head, I
`5 wouldn't know, I'm afraid.
`6 Q. That's fine.
`7 So I think I know what your answer's going
`8 to be, but what percentage of your procedures in the 2000
`9 to 2005 time frame used a fixed wire balloon?
`10 A. Zero.
`11 Q. Have you ever used fixed wire balloons in your
`12 practice?
`13 A. They were not available in the time I've been
`14 practicing.
`15 Q. So I think you mentioned steerability just a
`16 second ago as one of the ways that a fixed wire balloon
`17 behaves differently than an over-the-wire balloon,
`18 correct?
`19 A. Correct.
`20 Q. Are there any other considerations a physician
`21 has to take into consideration when using a fixed wire
`22 balloon that you don't have to consider with an
`23 over-the-wire balloon?
`24 A. The balloon itself is -- the very nature of it
`25 is flimsier, because it's the -- it's the -- for want of
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`1 Do you understand that to be the same
`2 thing as an over-the-wire catheter?
`3 A. No.
`4 Q. Okay. What's an over-the-wire catheter?
`5 A. An over-the-wire catheter is any long catheter,
`6 usually a 190 centimeter catheter that is not rapid
`7 exchange; but it doesn't have to be a balloon catheter.
`8 Q. So is a over-the-wire balloon catheter a type
`9 of over-the-wire catheter then?
`10 A. It's a type of balloon.
`11 Q. All right. We'll come back to that, then.
`12 What was -- in the 2000 to 2005 time
`13 frame, what was the typical profile of a fixed wire
`14 balloon?
`15 A. Fixed wire balloons, I did not use.
`16 Q. Okay.
`17 A. So fixed wire balloons were the -- they were
`18 the first iteration. And, again, I mentioned this in my
`19 declaration, the first angioplasty in '90 -- in '77 used
`20 this, but they were very difficult to steer; and the next
`21 iteration was over-the-wire balloons.
`22 So I'm afraid I did not use -- I have
`23 never used a fixed wire balloon.
`24 Q. And that's my fault, Doctor. I jumped ahead to
`25 my next question. I -- we'll get to fixed wire in a
`
`1 a better word, the plastic balloon catheter you're
`2 pushing on.
`3 An over-the-wire balloon, although you're
`4 pushing on the plastic balloon catheter, it's buttressed
`5 or it's supported by a wire that goes through the center
`6 of it. So you slide it over the rail of that wire.
`7 The fixed wire balloon, you're trying to
`8 push the balloon catheter with a wire at the end of it,
`9 so it's a thin, pliable plastic with the wire at the
`10 end.
`11 So there may be differences in profile,
`12 and the -- the effect of flimsiness or fragility of the
`13 balloon.
`14 Q. Do fixed wire balloons behave any differently
`15 than over-the-wire balloons during advancements within
`16 the catheter?
`17 A. So I personally have no experience of this, but
`18 from talking to colleagues that use them, yes, they found
`19 them -- they were more prone to buckling in the catheter,
`20 getting them to the -- to the coronary ostium.
`21 You could usually get them there, but
`22 trying to get them out of the catheter into the ostium,
`23 there was a take danger of them buckling.
`24 Q. All right. But no experience yourself using --
`25 A. No. As I said, I've never used fixed wire
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`1 balloons.
`2 Q. All right. So I want to stick focused in the
`3 2000, 2005 time frame.
`4 What percentage of your PCI procedures
`5 used a stent?
`6 A. The vast majority.
`7 So in that time frame, really the only
`8 reason for not placing a stent was if you could not
`9 deploy one or if there was another reason.
`10 So I would say that 95 percent would have
`11 employed a stent.
`12 Q. Again, sticking within the same time frame,
`13 what percentage of your PCI procedures were routine?
`14 A. Probably -- what was considered complex then,
`15 i.e., there were things that we just wouldn't attempt
`16 then that we now do. So the majority would have been
`17 considered routine, and so probably 60 percent would have
`18 been routine, 40 percent complex.
`19 But what I considered complex then, I
`20 don't really consider it as much -- as complex now. And
`21 cases that we wouldn't have attempted or I wouldn't have
`22 attempted then, I now do weekly.
`23 Q. We'll get to current time in just a second,
`24 Doctor. I want to step back, and that's why I started
`25 with sort of the A, B, and C ranking before. So I'm just
`
`1 other ways to treat the lesion are available?
`2 A. I think it's a function of -- of time. I
`3 think it's a function of quite a few things.
`4 That in -- in the early '90s, when I came
`5 out of medical school, angioplasty was being performed in
`6 fairly young people; because if you had significant
`7 disease, we didn't attempt angioplasty, and you went for
`8 bypass surgery.
`9 But as the population ages and as more
`10 people are 10, 15, 20 years out from previous bypass
`11 surgery, there are a lot more patients now, older
`12 patients who are no longer surgical candidates because
`13 they've had bypass before.
`14 And so there are more complex lesions now,
`15 and we've had to refine our techniques and our abilities
`16 to treat this growing -- this growing population of
`17 patients.
`18 Q. All right. Let's move forward, Doctor, to
`19 your -- the 2005 to 2008 time frame. Okay?
`20 A. Yes.
`21 Q. I think you mention in your declaration that
`22 you performed, roughly, a thousand angioplasties during
`23 that time period?
`24 A. That's correct, yes.
`25 Q. How many of those procedures would have been
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`1 trying to understand.
`2 Obviously that ranking was in existence in
`3 this time period, the 2000, 2005 time period, correct?
`4 A. Correct.
`5 Q. All right. And so if it was an A procedure in
`6 1993, it should also be an A procedure in 2000, correct?
`7 A. Well, the procedure is looking at a les