`
`Director of Experimental Cardiology
`
`David Meerkin
`
`Shaare Zedek Medical Center
`
`Jerusalem
`
`Teleflex Ex. 2149
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`Medtronic v. Teleflex
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`Page 1
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`Teleflex Ex. 2149
`Medtronic v. Teleflex
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`
`
`of procedural failure
`
`Factors
`
`Poor back up i force before guide
`
`displacement
`
`Failure to deliver a stent is a frequent cause
`
`
`
`Tortuousity i distal transmission of force
`
`Friction between rigid stent and vessel wall
`
`Teleflex Ex. 2149
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`Medtronic v. Teleflex
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`Page 2
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`Teleflex Ex. 2149
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`SVG PCI accounts for between 5-10% of PCI
`
`procedures
`
`technically more
`procedures
`PCI
`SVG
`challenging than native coronary arteries
`
`
`
`Previous CABG shown to increase failure rate of
`
`trans radial PCI procedures 7-fold. Jacc Intv, 2009;
`2(11]:1057-1DB4.
`
`Teleflex Ex. 2149
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`SVG—PCI include:
`
`' Inadequate Guide Catheter Support
`
`- Inability to reach ostium and cannulate SVG
`
`- Difficulties encountered during
`
`
`
`' Competitive Flow
`
`- Achieving deep seating of guide catheter in
`
`SVG
`
`- Extreme Tortuosity
`
`Teleflex Ex. 2149
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`Page 4
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`Teleflex Ex. 2149
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`Support guide - T force before
`
`displacement
`
`Support I buddy wire
`
`- reduce
`
`tortuousity
`
`
`
`Lesion preparation I lower profile stent
`
`- Jr friction
`
`Teleflex Ex. 2149
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`Medtronic v. Teleflex
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`Page 5
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`Distal anchor balloon
`
`T backup support by locking guide
`
`
`
`may increase friction (2 catheters in
`lesion)
`
`requires 2 7F to accommodate inflated
`
`balloon + stent
`
`Teleflex Ex. 2149
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`Medtronic v. Teleflex
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`Page 6
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`Teleflex Ex. 2149
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`Stentoatheter
`advanced through
`
`proximal obstruction
`
`1-—_
`
`Distal anchor
`
`balloon — JR4
`
`9 U ide
`
`inoreased foroe on
`
`stent before
`
`displacement
`
`Need 2‘: 7"F
`
`
`
`\ Guide looked in
`position allowing
`
`Balloon inflated in distal
`
`vessel
`
`Teleflex Ex. 2149
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`Medtronic v. Teleflex
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`Page 7
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`Guide catheter extension
`
`Greatly increases back-up support
`
`'- Shape modification ‘Amplatzing' T contact in aorta
`
`- Deep intubation increases contact within the coronary
`artery
`
`
`
`Can be advanced through proximally deployed
`stents
`
`May traverse proximal obstruction
`
`- more flexible than a stent
`
`Can be advanced using distal anchor balloon
`
`- Requires only 6F without need for 2 catheters in lesion
`
`- Permits proximal to distal stenting
`
`Teleflex Ex. 2149
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`Medtronic v. Teleflex
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`Page 8
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`Teleflex Ex. 2149
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`JR4 guide
`
`limited support
`
`from contact with
`
`H
`
`opposite aortic
`wall
`
`Support from conventional JR4 guide
`
`
`
`Quebec 2010
`
`Teleflex Ex. 2149
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`Medtronic v. Teleflex
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`Page 9
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`Teleflex Ex. 2149
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`resistance to stent passage
`
`causes guide to back eut —
`
`backup is lest as guide
`comes away from coronary
`
`Guide catheter backing out
`
`
`
`esteum & aertic wall
`
`\
`[Al/4‘L1“-
`
`Teleflex Ex. 2149
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`Page 10
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`Teleflex Ex. 2149
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`“Mother and Child"
`
`5F through standard 6F
`(CordislMedtrcnic/Boston etc) guide
`
`
`
`Classically used
`
`Terumo Heartrail 125cm guide
`
`Teleflex Ex. 2149
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`Page 11
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`Teleflex Ex. 2149
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`Shape change of guide
`
`Deep intubation of coronary
`
`Deep intubation
`
`adds greatly
`
`increases contact
`
`within coronary
`
`artery greatly
`
`increasing support
`
`\
`
`‘l
`
`Mechanisms of increasing backup with guide
`catheter extension
`
`
`
`f
`
`Shape change of JR4 into
`
`‘Amplatz Left‘ shape increases
`
`contact aorta increasing support
`
`Teleflex Ex. 2149
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`Medtronic v. Teleflex
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`Page 12
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`Page 13
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`Teleflex Ex. 2149
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`Coaxial
`
`“mother and child”
`
`
`
`guide extension
`
`with
`
`rapid exchange
`
`convenience
`
`Teleflex Ex. 2149
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`Medtronic v. Teleflex
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`Page 14
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`Teleflex Ex. 2149
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`3' 20cm guide extension connected to
`
`
`
`-" Guidewires, balloons and stents
`
`enter the GuideLiner’s collar within
`
`the guide catheter
`
`Teleflex Ex. 2149
`
`Medtronic v. Teleflex
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`a push-rod with a “collar”
`
`t Flexible GuideLiner extension can
`
`be deep seated for mother-and-child
`
`back-up support
`
`
`Page 15
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`Teleflex Ex. 2149
`Medtronic v. Teleflex
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`3 3 3
`
`
`
`Guide catheter
`
`Tip of GuideLiner
`
`GuideLiner
`
`positioned at osiium
`
`deployed inio
`
`odvoneed dieioliy up
`
`ofRCA
`
`RCA
`
`to 106m into vessel
`
`Teleflex Ex. 2149
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`Medtronic v. Teleflex
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`Page 16
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`Teleflex Ex. 2149
`Medtronic v. Teleflex
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`
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`Teleflex Ex. 2149
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`Medtronic v. Teleflex
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`Page 17
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`Teleflex Ex. 2149
`Medtronic v. Teleflex
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`Distal anchor to insert Guideliner,
`staged stent insertion
`
`\
`
`F
`Anchor balloon
`
`removed after
`
`Guideliner advanced1,;’
`through proximal
`_
`2
`obstructionrs
`'
`F g-\8
`
`
`
`’i
`
`I
`
`l\
`Guide locked in position allowing
`
`increased force on Guideliner
`
`before displacement 6F
`
`Guideliner crossing
`_.Fri—7"“!
`
`I
`
`Balloon inflated in distal
`
`vessel
`
`Stent advanced without
`
`resistance within Guideliner
`
`catheter
`
`Teleflex Ex. 2149
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`Medtronic v. Teleflex
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`Page 18
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`Teleflex Ex. 2149
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`
`
`Severe proximal
`
`disease causes
`
`pressure damping 12+
`
`prevents serenary
`
`intubatien
`
`Severe proximal and distal disease
`
`
`
`Distal disease eann
`
`be reached
`
`Teleflex Ex. 2149
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`Medtronic v. Teleflex
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`Page 19
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`Teleflex Ex. 2149
`Medtronic v. Teleflex
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`
`
`stent undeployed
`
`stent expanded opens
`.
`proximal vessel
`
`k
`K}
`
`Guideliner increases
`
`support to allow stent
`
`advancement into
`
`Guideliner assisted proximal then
`distal stenting
`
`
`
`Guideliner advanced
`through deployed stent
`yak vessel
`
`allowing access to distal
`
`.c- ‘23:.
`Kat—1r—
`
`proximal lesion
`
`Teleflex Ex. 2149
`
`Medtronic v. Teleflex
`
`
`Page 20
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Irragea'zezSIEy'SIE
`View size: 30E: 3r: EH36
`W; 102 WW:
`'20::
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`.
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`(NEW) — unramed
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`
`ESIUEJIEUUQ 39:54:28
`
`Made In DSiHH
`
`Teleflex Ex. 2149
`
`Page 21
`
`Medtronic v. Teleflex
`
`
`Page 21
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`Magi-SEES]? 36512
`View size: 30E: 3r: 30E
`
`W; '91 WW: 1331*
`- "
`
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`
`Teleflex Ex. 2149
`
`Medtronic v. Teleflex
`
`
`Page 22
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`1WBQESiEEZS12K512
`1New size: 80% :r: EOE:
`11"-: 22 WW 155-
`
`|"1| 12}J?1}r1
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`
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`
`ESIZIEHEUZJQ 10:21:23
`
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`
`Teleflex Ex. 2149
`
`Medtronic v. Teleflex
`
`
`Page 23
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`|mage5izez5|2x512
`View EiEE':
`ctS-LJIJ
`:x: jun
`WL: "30 WW: 1?";
`
`“1E??y,?1y3|
`Angogram-JLIHHFII — urnamed
`2200500
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`EUIJIII. 15 ~33.
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`Im- 1mm
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`Maje In UsiriH
`
`Teleflex Ex. 2149
`
`Medtronic v. Teleflex
`
`
`Page 24
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`ln'ace Size-r: 531?. 3:15:31}
`Viaw SiEt': EDIE x EOE)
`W;
`IUD ‘v'vr‘w‘: 21L]
`
`'9'] y]
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`|"1I
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`Irr: 1:55
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`
`Teleflex Ex. 2149
`
`Medtronic v. Teleflex
`
`
`Page 25
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`E113 :'_|.’_:- [1111; H
`
`.r.-'
`
`11:11.1: 11111-12511
`
`II. 1:11..
`
`5571
`
`6F (5-in-6)
`
`6F ID. 3 0.010”
`
`11.056”
`
`(173111111)
`
`(142111111)
`
`5572
`
`1F {6—in—1}
`
`7'1: ID. 3 0.1113”
`
`11.062”
`
`(193111111)
`
`(151111111)
`
`3.1 [111.1111; 1.1“" 111 1111111313111
`la—L
`'11. '-.I1I::'11fi'11539111'1'11E'-I'_|11|11-_13'-""
`
`
`
`5573
`
`3F {1—in—3}
`
`3F ID. 3 0.083”
`
`{1.0T1”
`
`(224111111)
`
`(130111111)
`
`Teleflex Ex. 2149
`
`Medtronic v. Teleflex
`
`
`Page 26
`
`Teleflex Ex. 2149
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`
`
`
`Conclusions
`
`
`
`The Guideliner offers the ability to
`“change course midstream” due to its
`rapid exchange nature as well as allow
`for staged anchoring and extremely
`safe deep cannulation
`
`Multiple techniques can be used in
`isolation or in combination to maximize
`
`and optimize guide catheter support to
`deal with most limitations
`
`Teleflex Ex. 2149
`
`Medtronic v. Teleflex
`
`
`Page 27
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
`
`The combination of Sheathless
`
`catheters (6.5F and 7.5F) and 5 in 6
`and 6 in 7 Guideliners allows for
`
`Conclusions
`
`faced in daily coronary practice
`
`the expansion of the transradial
`approach to almost every scenario
`
`
`Page 28
`
`Teleflex Ex. 2149
`Medtronic v. Teleflex
`
`
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