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`Page 1
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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.
`
`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)
`___________________________________________________
`
` VIDEOTAPED DEPOSITION OF
` DR. STEPHEN BRECKER
`
`DATE: January 14, 2021
`
`TIME: 5:06 a.m. (Central Standard Time)
`
`PLACE: Veritext Virtual Videoconference
`
`REPORTED BY: PAULA K. RICHTER, RMR, CRR, CRC
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
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`Page 2
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`Page 4
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`1 INDEX
`2 WITNESS: DR. STEPHEN BRECKER PAGE:
`3 EXAMINATION BY MR. VANDENBURGH............. 8
`4 EXAMINATION BY MS. ROBERG-PEREZ............ 178
`5 FURTHER EXAMINATION BY MR. VANDENBURGH..... 181
`
`6 7
`
`EXHIBITS MARKED: PAGE:
`8 EXHIBIT 2222 Teleflex Pronto V3 Extraction
`9 Catheter Brochure............... 84
`10 EXHIBIT 2223 Catheter Figures................ 43
`11 EXHIBIT 2224 U.S. Patent 7,273,486........... 45
`12 EXHIBIT 2225 Page 57 from Exhibit 1807,
`13 Jones Declaration............... 146
`14 EXHIBIT 2226 Modified Kontos Devices......... 160
`15 EXHIBIT 2227 Article - Advances in
`16 Procedural Techniques -
`17 Antegrade....................... 174
`18
`19 (Original exhibits attached to original transcript;
`20 copies provided to counsel.)
`21
`22 EXHIBITS PREVIOUSLY MARKED AND REFERRED TO:
`23 EXHIBIT 1007 U.S. Patent 7,736,355.......... 59
`24 EXHIBIT 1008 U.S. Patent 7,604,612.......... 65
`25 (EXHIBITS continued on next page)
`
`1 APPEARANCES
`2 (All parties appeared via videoconference)
`3 ON BEHALF OF THE PETITIONERS:
`4 Ms. Sharon Roberg-Perez, Esq.
`5 Mr. Cyrus A. Morton, Esq.
`6 Mr. Christopher A. Pinahs, Esq.
`7 ROBINS KAPLAN, LLP
`8 800 LaSalle Avenue, Suite 2800
`9 Minneapolis, Minnesota 55401
`10 (612) 349-8500
`11 sroberg-perez@robinskaplan.com
`12 cmorton@robinskaplan.com
`13 cpinahs@robinskaplan.com
`14
`15 ON BEHALF OF THE PATENT OWNER:
`16 Mr. J. Derek Vandenburgh, Esq.
`17 Mr. Peter M. Kohlhepp, Esq.
`18 CARLSON, CASPERS, VANDENBURGH & LINDQUIST
`19 225 South Sixth Street, Suite 4200
`20 Minneapolis, Minnesota 55402
`21 (612) 436-9600
`22 dvandenburgh@carlsoncaspers.com
`23 pkohlhepp@carlsoncaspers.com
`24
`25 (APPEARANCES continued on next page)
`
`Page 3
`
`Page 5
`
`1 APPEARANCES (Continued)
`2 ON BEHALF OF PATENT OWNER:
`3 Mr. Kenneth E. Levitt, Esq.
`4 THE DORSEY FIRM
`5 50 South Sixth Street, Suite 1500
`6 Minneapolis, Minnesota 55402
`7 (612) 340-2600
`8 levitt.kenneth@dorsey.com
`9
`10
`11 ALSO PRESENT BY VIDEOCONFERENCE:
`12 Phil Glauberson - Videographer
`13 Greg Smock - Teleflex 05:05:52
`14 05:06:09
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1 (EXHIBITS continued)
`2 EXHIBIT 1009 U.S. Patent 5,439,445.......... 59
`3 EXHIBIT 1115 6/15/18 Deposition Transcript
`4 of Howard Root................. 120
`5 EXHIBIT 1806 Supplemental Declaration of
`6 Dr. Stephen Brecker............ 8
`7 EXHIBIT 1840 Article - Coaxial Technique for
`8 Catheterization of the Coronary
`9 Arteries With a Very Dilated
`10 Ascending Aorta by Geijer...... 34
`11 EXHIBIT 1841 Case Report - Coaxial Double
`12 Catheter Followed by Buddy Wire
`13 Placement by Furuichi.......... 34
`14
`15
`16
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`18
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`1 P R O C E E D I N G S
`2 THE VIDEOGRAPHER: Good morning. We 05:06:09
`3 are going on the record at 5:06 a.m. Central Time, 05:06:10
`4 January 14, 2021. 05:06:18
`5 Please note that microphones are 05:06:20
`6 sensitive and may pick up whispering and private 05:06:23
`7 conversations. Please mute your microphone 05:06:25
`8 whenever possible. Audio and video recording will 05:06:29
`9 continue to take place unless all parties agree to 05:06:32
`10 go off the record. 05:06:35
`11 This is Media Unit 1 of the 05:06:38
`12 video-recorded deposition of Dr. Stephen Brecker, 05:06:41
`13 in the matter of Medtronic, Inc., et al. versus 05:06:44
`14 Teleflex Innovations, S.A.R.L., filed in the U.S. 05:06:52
`15 Patent and Trademark Office, Numbers 05:07:05
`16 IPR2020-00126, IPR2020-00129 -- 128, 05:07:08
`17 IPR2020-00129, IPR2020-00132, IPR2020-00134, 05:07:16
`18 IPR2020-00135, IPR2020-00137. 05:07:25
`19 This deposition is being held 05:07:32
`20 remotely. 05:07:34
`21 My name is Phil Glauberson from the 05:07:35
`22 firm Veritext, and I am the videographer. The 05:07:37
`23 court reporter is Paula Richter from Veritext. 05:07:40
`24 I am not authorized to administer an 05:07:43
`25 oath. I am not related to any party in this 05:07:46
`
`1 swear the witness, please. 05:08:57
`2 DR. STEPHEN BRECKER, 05:09:12
`3 duly sworn, was examined and testified as follows: 05:09:12
`4 EXAMINATION 05:09:12
`5 BY MR. VANDENBURGH: 05:09:12
`6 Q. All right. Good morning again, Dr. Brecker. 05:09:13
`7 A. Good morning. 05:09:16
`8 Q. I'm going to skip the usual intro. This is 05:09:17
`9 the third time that we've had one of these 05:09:19
`10 depositions. I guess the only thing I will ask 05:09:23
`11 is, is there anything that would prevent you from 05:09:27
`12 testifying truly or correctly today? 05:09:30
`13 A. There is not. 05:09:35
`14 Q. Okay. Can you -- I'm just going to just walk 05:09:37
`15 through your latest declaration today, so if you 05:09:40
`16 could just go ahead and pull that up and have that 05:09:44
`17 in front of you, the binder that we sent you, 05:09:47
`18 Exhibit 1806, for the record. 05:09:50
`19 A. I'm just going to make it a bit louder. 05:09:59
`20 Okay. 05:10:02
`21 Q. All right. And let's start near the 05:10:03
`22 beginning where you are talking on, oh, roughly 05:10:06
`23 paragraphs 7 through 13 regarding the term 05:10:13
`24 "interventional cardiology devices," and in 05:10:18
`25 particular, the Venn diagram that you have in 05:10:24
`
`Page 7
`
`Page 9
`
`1 action, nor am I financially interested in the 05:07:49
`2 outcome. 05:07:51
`3 Counsel will please now state their 05:07:52
`4 appearances and affiliations for the record. If 05:07:55
`5 there are any objections to proceeding or to the 05:07:58
`6 court reporter administering the oath virtually, 05:08:00
`7 please state them at the time of your appearance, 05:08:03
`8 beginning with the noticing attorney. 05:08:06
`9 MR. VANDENBURGH: Yes. On behalf of 05:08:07
`10 the Patent Owner, Teleflex, this is Derek 05:08:09
`11 Vandenburgh of the Carlson Caspers firm. Also 05:08:12
`12 with us today is Peter Kohlhepp of our firm, Ken 05:08:15
`13 Levitt of the Dorsey firm, and Greg Smock of 05:08:22
`14 Teleflex. 05:08:25
`15 MS. ROBERG-PEREZ: On behalf of 05:08:26
`16 Petitioner, Medtronic, Sharon Roberg-Perez of 05:08:27
`17 Robins Kaplan. With me are my colleagues, Chris 05:08:31
`18 Pinahs and Cy Morton. 05:08:35
`19 MR. VANDENBURGH: And before we 05:08:39
`20 swear the witness, I'll just state for the record, 05:08:40
`21 I appreciate the list of cases, Phil, but there 05:08:41
`22 are actually 11 total all together. I don't think 05:08:44
`23 they were all on your list, but I think counsel 05:08:46
`24 all understand which IPRs that are at issue here. 05:08:48
`25 So, Paula, can you go ahead and 05:08:55
`
`1 paragraph 12. 05:10:28
`2 Is it your opinion that everything 05:10:32
`3 that is used during an interventional cardiology 05:10:35
`4 procedure is an interventional cardiology device 05:10:40
`5 as that term is used in the Teleflex patents? 05:10:44
`6 A. Well, just to break that up, first of all, 05:10:53
`7 everything used -- not everything used in an 05:10:59
`8 interventional cardiology procedure would 05:11:03
`9 necessarily be called an interventional cardiology 05:11:07
`10 device, just thinking about it in the broadest 05:11:11
`11 sense. 05:11:13
`12 When you say how is an 05:11:17
`13 interventional cardiology device defined in the 05:11:20
`14 Teleflex patent, that's a separate issue; and 05:11:22
`15 there are various interpretations on that, as we 05:11:29
`16 have discussed. 05:11:32
`17 Q. So it sounds like you would agree that the 05:11:35
`18 term as it's used in the patents is not the same 05:11:42
`19 as it may be used outside the context of the 05:11:48
`20 patents? 05:11:51
`21 MS. ROBERG-PEREZ: Object to form. 05:11:52
`22 THE WITNESS: It may or may not be. 05:11:56
`23 BY MR. VANDENBURGH: 05:12:00
`24 Q. Okay. So there are certainly instances where 05:12:00
`25 what's considered to be an interventional 05:12:08
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`Page 10
`1 cardiology device outside the scope of the patents 05:12:10
`2 is broader than how you would use that term within 05:12:12
`3 the patent itself? 05:12:17
`4 A. That's correct. There are interventional 05:12:20
`5 cardiology devices which may not fulfill the 05:12:25
`6 criteria of an interventional cardiology device as 05:12:33
`7 one might interpret it in the patent. It's not 05:12:35
`8 defined in the patent. 05:12:40
`9 Q. I'm sorry. So it is -- you do consider it to 05:12:42
`10 be defined in the patent? 05:12:46
`11 MS. ROBERG-PEREZ: Object to form. 05:12:48
`12 THE WITNESS: No. I said it's not 05:12:49
`13 defined in the patent. 05:12:50
`14 BY MR. VANDENBURGH: 05:12:53
`15 Q. I misheard. 05:12:54
`16 So as it's used in the patent, would 05:12:57
`17 you consider a guide catheter to be an 05:13:01
`18 interventional cardiology device? 05:13:04
`19 A. When you say "as it's used in the patent," 05:13:18
`20 you would need to take me to a specific example. 05:13:20
`21 Q. Okay. 05:13:24
`22 A. There are examples in the patent where it 05:13:26
`23 says interventional cardiology device, dot, dot, 05:13:29
`24 dot, and then it gives a specification to it. I 05:13:32
`25 mean, a guide catheter is an interventional 05:13:37
`
`Page 11
`
`1 cardiology device in general terms. 05:13:42
`2 Q. Okay. So, for example, let's -- we can go 05:13:44
`3 ahead and pull up a specific patent. Do you have 05:13:50
`4 a binder with the patents in them? 05:13:53
`5 A. I do. That would be -- I've got binder 2 05:13:56
`6 from the original deposition, which has the 05:14:04
`7 patents. 05:14:10
`8 Q. Perfect. So let's use as an example the '776 05:14:11
`9 Patent, RE 45776. 05:14:16
`10 A. Have you got that as a -- yeah, I have that. 05:14:22
`11 That's 135. 1001-135 as I've got it marked. 05:14:26
`12 Q. I believe it's Exhibit 1001 to the 035 IPR. 05:14:33
`13 A. Yeah, I have that. 05:14:42
`14 Q. Okay. And if we go to Claim 25 of the '776 05:14:46
`15 Patent. 05:15:04
`16 A. I have it. 05:15:04
`17 Q. I believe you will see two-thirds of the way 05:15:04
`18 down the longer paragraph that starts, "A segment 05:15:08
`19 defining ..." It says, it needs to be configured 05:15:11
`20 to receive one or more interventional cardiology 05:15:14
`21 devices therethrough." 05:15:17
`22 So in the context that it's used 05:15:21
`23 there, would you consider a guide catheter to be 05:15:24
`24 an interventional cardiology device? 05:15:27
`25 A. It doesn't define an interventional 05:15:45
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`Page 12
`1 cardiology device. It just says that the segment 05:15:48
`2 defining a partially cylindrical opening is 05:15:53
`3 configured to receive one or more interventional 05:15:58
`4 cardiology devices. 05:16:01
`5 Now, it's saying it's configured to 05:16:06
`6 receive devices. That doesn't -- if you're saying 05:16:09
`7 could -- let me -- could any device be considered 05:16:15
`8 an interventional cardiology device, well, it 05:16:20
`9 could still be considered an interventional 05:16:23
`10 cardiology device without it necessarily 05:16:26
`11 fulfilling the ability for this to be configured 05:16:27
`12 to it, to accept it. This doesn't define an 05:16:33
`13 interventional cardiology device. 05:16:37
`14 Q. I agree. I'm not trying to at this point -- 05:16:39
`15 A. Yeah. 05:16:43
`16 Q. -- you know, get to a definition. I just 05:16:43
`17 want to understand when -- that term has a 05:16:46
`18 meaning, correct? We need to gives words and 05:16:52
`19 claims meaning. You understand that? 05:16:55
`20 A. I do. 05:16:57
`21 Q. Okay. So as those words are used in that 05:16:58
`22 claim, interventional cardiology device, what does 05:17:01
`23 it mean? 05:17:05
`24 A. Well, this -- what it means is a device that 05:17:06
`25 can go through a guide extension catheter. 05:17:09
`
`Page 13
`1 Q. Okay. So does that mean that anything that 05:17:13
`2 can go through a guide extension catheter is an 05:17:16
`3 interventional cardiology device within the scope 05:17:20
`4 of that claim, in your opinion? 05:17:22
`5 A. I'm not -- I'm not quite sure I understand. 05:17:29
`6 Anything that could go through an -- a guide 05:17:34
`7 extension catheter -- you're asking me in a 05:17:40
`8 different direction. This is simply saying 05:17:46
`9 that -- this is giving characteristics of a guide 05:17:50
`10 extension catheter and saying it's configured to 05:17:52
`11 accept one or more interventional cardiology 05:17:56
`12 devices, but that doesn't define what an 05:17:57
`13 interventional cardiology device -- nor does it 05:18:03
`14 say that anything, absolutely anything that goes 05:18:05
`15 through would be a device. So I'm struggling to 05:18:10
`16 think of something that you would put through a 05:18:14
`17 guide extension catheter that wouldn't be a 05:18:16
`18 device. I mean -- 05:18:19
`19 Q. Wouldn't it be an -- just to clarify, 05:18:21
`20 wouldn't it be an interventional cardiology 05:18:24
`21 device? 05:18:27
`22 A. Yes. I'm struggling to think of an example 05:18:29
`23 of something that a cardiologist would put through 05:18:33
`24 a guide extension catheter that wouldn't be an 05:18:38
`25 interventional cardiology device. I can't 05:18:42
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`1 think -- I mean, I -- you know, you could inject 05:18:47
`2 drugs, for example. But, I mean, in terms of a 05:18:52
`3 piece of kit, if you were advancing a piece of 05:18:57
`4 equipment through a guide extension catheter, it 05:19:01
`5 would be an interventional cardiology device. 05:19:06
`6 Q. Okay. So you can't think of anything that a 05:19:09
`7 cardiologist would put through a guide extension 05:19:15
`8 catheter that would not be an interventional 05:19:22
`9 cardiology device? 05:19:24
`10 A. I'm struggling to think of an example. 05:19:27
`11 Q. Okay. Now, is it your opinion -- because you 05:19:30
`12 used the word "through," is it your opinion that 05:19:35
`13 to be an interventional cardiology device, it has 05:19:39
`14 to come out the other side of the guide extension 05:19:42
`15 catheter? 05:19:45
`16 MS. ROBERG-PEREZ: Object to form. 05:19:45
`17 THE WITNESS: Again, if you're tying 05:19:57
`18 me to the language of the claim, again, this is 05:19:59
`19 defining what the guide extension catheter is 05:20:04
`20 doing, not what the interventional cardiology 05:20:09
`21 device is doing. 05:20:11
`22 For example, if you were advancing a 05:20:15
`23 stent through the extension catheter but you 05:20:18
`24 couldn't actually, for one reason or another, exit 05:20:26
`25 the extension catheter, that doesn't mean that the 05:20:28
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`Page 15
`1 stent is not an interventional cardiology device. 05:20:34
`2 BY MR. VANDENBURGH: 05:20:40
`3 Q. Now, an interventional cardiology device can 05:20:46
`4 also include things that just go into the guide 05:20:50
`5 catheter, right? 05:20:52
`6 MS. ROBERG-PEREZ: Object to form. 05:20:54
`7 THE WITNESS: It's possible, but do 05:21:03
`8 you have an example in mind? 05:21:07
`9 BY MR. VANDENBURGH: 05:21:08
`10 Q. Well, I mean, a stent catheter is an 05:21:08
`11 interventional cardiology device regardless of 05:21:11
`12 whether it's put in a guide catheter or a guide 05:21:13
`13 extension catheter, right? 05:21:16
`14 A. That's correct, yes. And that's the point I 05:21:17
`15 was making. 05:21:20
`16 Q. Yeah, yeah. Now, would a syringe for 05:21:21
`17 injecting contrast be considered to be an 05:21:28
`18 interventional cardiology device? 05:21:32
`19 A. Well, now, stepping back out of the context 05:21:38
`20 of the claims, if I went upstairs to the cath labs 05:21:42
`21 and asked my colleague, is that syringe that 05:21:48
`22 you're using to inject an interventional 05:21:51
`23 cardiology device, you'd get a range of answers. 05:21:53
`24 Q. Okay. So the answer is, if it's outside the 05:21:59
`25 scope of the patent, it depends on who you ask. 05:22:01
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`Page 16
`1 A. Yes. I mean, there are some syringes that 05:22:06
`2 are very specifically adapted and have 05:22:09
`3 characteristics to them, and there are some 05:22:10
`4 devices that are used for injection, like an 05:22:13
`5 automated injector. And I think many 05:22:16
`6 cardiologists would consider those interventional 05:22:19
`7 cardiology devices in the broadest general sense. 05:22:23
`8 But they wouldn't -- they wouldn't go into the 05:22:29
`9 guide catheter. 05:22:32
`10 Q. Okay. Does -- let's see. Does any part of 05:22:33
`11 the syringe go into the proximal end of the guide 05:22:43
`12 catheter? 05:22:47
`13 A. Well, the syringe typically does not. There 05:22:50
`14 is -- the syringe is attached to a manifold which 05:22:55
`15 has three-way taps on it and terminates in a flush 05:22:59
`16 port, that you then -- you screw onto the hub of 05:23:07
`17 the guide catheter -- well, you screw onto the hub 05:23:12
`18 of the O-ring hemostatic valve that screws onto 05:23:16
`19 the guide catheter. 05:23:20
`20 Q. Okay. All right. 05:23:21
`21 A. You don't inject -- you don't attach the 05:23:22
`22 syringe directly to a guide catheter heart. 05:23:25
`23 Q. Right. Right. The hemostatic valve, does it 05:23:29
`24 actually engage within the proximal end of the 05:23:31
`25 guide catheter? 05:23:35
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`Page 17
`1 A. Well, the guide catheter will terminate in a 05:23:37
`2 hub. So the material of the -- the catheter will 05:23:41
`3 terminate at its proximal end in a hub made of 05:23:51
`4 plastic and that's the bit that screws onto the 05:23:59
`5 manifold. You -- where the hub is considered part 05:24:01
`6 of the guide catheter. I suppose it is, but it's 05:24:04
`7 a matter of debate, I suppose. I haven't thought 05:24:07
`8 about it. 05:24:11
`9 Q. So have you applied a definition of 05:24:12
`10 interventional cardiology device as you analyzed, 05:24:18
`11 for example, Claim 25 of the '776 Patent? 05:24:22
`12 A. So looking at Claim 25 -- and I'd just like 05:24:31
`13 to -- although I've read it several times, I just 05:24:34
`14 want to read it through myself again because I 05:24:36
`15 want to be -- I want to give you an accurate 05:24:39
`16 answer. (Reviews document.) 05:24:41
`17 The claim is describing 05:25:01
`18 characteristics of the guide extension catheter, 05:25:03
`19 and it's saying it's configured to receive 05:25:05
`20 interventional cardiology devices. So what the 05:25:08
`21 cardiologist is thinking reading that is, of all 05:25:15
`22 the interventional cardiology devices that exist, 05:25:19
`23 the ones that this is referring to are those that 05:25:20
`24 would be passed through or those that would be 05:25:23
`25 passed into, because it's configured to receive, 05:25:26
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`1 an interventional cardiology device. So what it 05:25:33
`2 is being -- what is being said is it's those 05:25:35
`3 devices which would go into a guide extension 05:25:39
`4 catheter. 05:25:47
`5 Q. Let me ask you specifically about guidewires. 05:26:00
`6 Now, you cite to the deposition 05:26:08
`7 transcript of Dr. Graham in your supplemental 05:26:10
`8 report, correct? 05:26:14
`9 A. I do. 05:26:16
`10 Q. Did you read his transcripts? 05:26:16
`11 A. I have. 05:26:20
`12 Q. Okay. Remind me, did you actually sit in on 05:26:22
`13 his depositions? 05:26:28
`14 A. I did not. 05:26:29
`15 Q. Do you recall from reading his transcripts 05:26:29
`16 that he testified that often a guidewire will 05:26:36
`17 actually help to open a nearly closed lesion as 05:26:42
`18 you're passing the guidewire through the lesion. 05:26:50
`19 Do you remember that? Did you see that testimony? 05:26:54
`20 A. So -- 05:26:56
`21 Q. Now I'm just asking if you saw the testimony. 05:27:00
`22 A. I can't remember reading it. I am aware that 05:27:03
`23 he has said it. I do not -- I do not recall him 05:27:07
`24 saying that that would be the case often, so I 05:27:09
`25 can't recall, sitting here now, the exact words. 05:27:12
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`Page 19
`1 Q. I want to start by asking: Have you had the 05:27:15
`2 similar experience? Have you found that in at 05:27:21
`3 least some instances, blood flow can be improved 05:27:24
`4 simply by pushing the guidewire through the 05:27:30
`5 occlusion? 05:27:34
`6 A. So the guidewire doesn't treat the lesion. 05:27:35
`7 That's the starting point. What Dr. Graham, I 05:27:39
`8 think, is referring to is, when you start with a 05:27:43
`9 completely occluded vessel, when you inject 05:27:46
`10 contrast, you see nothing, no perfusion at all. 05:27:53
`11 When you put the guidewire through, 05:27:57
`12 you can on occasions then see the fusion of 05:28:00
`13 contrast and blood going down the vessel. That 05:28:06
`14 act in of itself would not be considered 05:28:11
`15 treatment, if that's, I think, what the question 05:28:17
`16 is weighted towards. 05:28:20
`17 Q. Well, you've answered a lot of other 05:28:22
`18 questions that I might have gotten to, but 05:28:25
`19 actually the question I asked is: In the course 05:28:27
`20 when you used to treat patients, would you 05:28:31
`21 sometimes help to restore blood flow simply by 05:28:38
`22 passing the guidewire through the lesion? 05:28:46
`23 A. Not by intention. 05:28:49
`24 Q. Okay. But it, in fact, would occur, correct? 05:28:51
`25 A. It can occur, that after passing the 05:28:56
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`Page 20
`1 guidewire, you can then see some flow; whereas, 05:29:01
`2 prior to passing the guidewire, there is no flow. 05:29:06
`3 Q. And while I understand that you might not 05:29:08
`4 stop there, that is a good thing for the patient, 05:29:17
`5 is it not, getting some additional flow? 05:29:20
`6 MS. ROBERG-PEREZ: Object to form. 05:29:23
`7 THE WITNESS: It's the starting 05:29:30
`8 point of a procedure. 05:29:31
`9 BY MR. VANDENBURGH: 05:29:34
`10 Q. Understood. I think I've heard anecdotally 05:29:34
`11 about people -- you know, they refer to having a 05:29:39
`12 90 percent blockage or 100 percent blockage. I 05:29:42
`13 take it a 90 percent blockage is better than 100 05:29:45
`14 percent blockage. 05:29:51
`15 MS. ROBERG-PEREZ: Object to form. 05:29:53
`16 THE WITNESS: It depends if you're 05:29:54
`17 talking about a chronic situation or an acute 05:29:56
`18 situation. 05:30:00
`19 BY MR. VANDENBURGH: 05:30:01
`20 Q. Okay. 05:30:01
`21 A. The acute situation of a completely blocked 05:30:03
`22 vessel, when you then put the guidewire down and 05:30:09
`23 you can then see some flow, that is not a bad 05:30:15
`24 thing. 05:30:18
`25 Q. That is a good thing, is it not? 05:30:20
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`Page 21
`1 A. It doesn't define that the blockage is now 90 05:30:22
`2 percent. All that you are seeing is some distal 05:30:27
`3 penetration of contrast into the distal vessel. 05:30:33
`4 Q. Okay. And does that indicate that some blood 05:30:41
`5 flow has been restored? 05:30:48
`6 A. Yes. 05:30:49
`7 Q. And is that a bad thing? 05:30:49
`8 A. No, it is not a bad thing. 05:30:54
`9 Q. Is it a good thing? 05:30:56
`10 A. It can -- it can be. It's not a bad thing. 05:30:57
`11 I mean, you don't -- you don't relax at that point 05:31:04
`12 in a primary angioplasty procedure. You would 05:31:07
`13 never turn around and say, good. Right. Let's -- 05:31:12
`14 you wouldn't describe -- I've never described it 05:31:20
`15 as a good thing. It happens. That's the start of 05:31:23
`16 the procedure. 05:31:26
`17 Q. Do you -- when this happens, when you 05:31:31
`18 actually are -- in the course the procedure, the 05:31:54
`19 guidewire, it reopens a blocked artery. Do you 05:31:57
`20 see at that point improved hemodynamics in the 05:32:02
`21 patient? 05:32:08
`22 A. So that can happen sometimes. I wouldn't 05:32:09
`23 describe it as hemodynamics. Let me correct my 05:32:14
`24 answer to that question. 05:32:20
`25 You wouldn't typically see improved 05:32:21
`
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`Page 22
`1 hemodynamics. You may see improvement in ST 05:32:24
`2 segment change. 05:32:27
`3 Q. And just because I didn't totally hear the 05:32:34
`4 answer to that, can you give that again? 05:32:37
`5 A. You wouldn't typically see improved 05:32:39
`6 hemodynamics by just having a wire across the 05:32:43
`7 occlusion, no. You may see improvement in ST 05:32:45
`8 segments on an ECG. 05:32:49
`9 Q. And I'm hearing NST? I mean, I understand -- 05:32:52
`10 you're basically talking about the cardiac wave 05:33:02
`11 form at this point? 05:33:04
`12 A. Yes. The ST segment. 05:33:05
`13 Q. ST segment. That's, I think, what I wasn't 05:33:07
`14 hearing correctly. Okay. So you're going to see 05:33:10
`15 improved cardiac wave form as a result of having 05:33:12
`16 reopened a blockage with a guidewire? 05:33:16
`17 MS. ROBERG-PEREZ: Object to form. 05:33:20
`18 THE WITNESS: You can. You can see 05:33:23
`19 that. I have also seen patients deteriorate at 05:33:26
`20 that point, with only partial reperfusion. 05:33:30
`21 BY MR. VANDENBURGH: 05:33:40
`22 Q. Let me ask you -- I'm going to switch gears a 05:33:52
`23 little bit to talk about suction catheters. And 05:33:54
`24 just to lay the groundwork, of course, one of the 05:34:03
`25 references that we have here is the Itou patent, 05:34:06
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`Page 23
`1 which is directed to