10C1817_EIJ28_TAP60_R80 30/06/10 1
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`The GuideLinerW “mud” catheter
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`intmdactian
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`8959‘ e the advancemmt
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`proce ares inducmg newer stem? am new ‘ fen; systems
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`=ver a stem to the fame? Region, especiaiiy if art
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`WM! cvmmex andmmy, var
`a com-“rum problem. Va
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`refiner hep with the.
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`inducimg Straightening the artery with a second "be-my”
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`wire-
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`61’ and vore supaert‘ve guici
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`. 0’ deep :nmm'iw Wm *he gm (Mg cathemr for back u:
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`support. HIE Hm’IWaK i: (femr'm,
`izykyi), Japan} “we an EX
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`,nwlving Eh»:
`insertion ofa flexible timed extra engih (129ml) 5 Fr catheter far
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`Geezer ir‘tubation with ext'a ”new Lp support has C“
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`in the literature: and is an ac
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`squC-ri am as: ivering slenlg in diff‘mil c
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`GuiceLiner‘” (Vascuw Solutions, Mwmeamfis, MN, USN The
`device rere ved CE marking in Septembe" 2009
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`Device am? tethiticai {fetafls
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`: with the
`The GuidoLir‘Um cathota is a mafia! guide 0x
`convenience 3f (and cxcha-‘ge‘
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`artery wheres-Q The (.
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`59! h)" deep seeing,
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`flexib e 20 cm 53:5th guic‘e ext;
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`, conneczed t: a steiniess steak push tube wt”: 3 "
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`r- be depcyed throum the exismg \‘la
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`my: ueivew (Figure 1),
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`CuiceLiner” does» no? increase {he werali g;id:ng carafe! ierg 2‘
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`guide. The GU define”M is :urranily a‘
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`”1-8 (O 071” ifiternak diatrretev’).
`The extcx‘mion is 20 cm Song be: a maxmw’s ex
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`C’TX (CC. JE) to asaist in D‘acement through the guide (
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`33163563523011?) “ff.“ 3.138
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`actvup gui‘co sugpor‘:
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`has 0:" the GuideLirer’” caiheier :5 :cr‘ira”‘dicated ir «355613 with
`lemma!" 3 5.5 mm diameter.
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`in :315330'*€ing
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`Téps am: tfickx fer aptfmai perfermance
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`a 0.011;" primary guidewzre to a maxxrrum of 10 CV77 teyond the
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`geidc tip m 31 moms-copy at} in no caSc [’JTI'E than 20 cm to
`prevent the meta! coHa‘ from exiting me gu diwg catheier.
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`1061817_EIJ28_TAP60_R80 30/06/10 18:35 P699278
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`200m rapid exchange section
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`Frure 1. We GuideUnerW Catheter. 777:5 cansists a.‘ a ijaxrbfe 20 cm strargnt guide extensron r-snnecre-s’ to a stainless 5:96! push Moe.
`‘ radiapaque marker 2.66 mm fircm riot Arrows.- wht
`positron/fig markers 21’ 94 cm rising'e armw} and Z05 cm (double arrows)
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`Or) initial ‘nsertimn of the GudeLmerW, :“
`pusf‘t-ror; stzwld
`as oriented =n a raters: :5 tior- within the guidmg catheter and
`ghmgid 1‘8 advanced ‘wtt'fiin {he gr) 2mg catheter WHOM ratation
`to avod wadping the gLidsw re arourd it.
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` the G: J rrwr M in t! e (mummy artery "an ha
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` 4 by using an uniirftatcc baioon catheter over the
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`orimary WW: mic) cistai vessel ~ f necessary thit» :ar fhcn be
`.nflated a: the target leaaor to act as an anchor, mowed by gentle
`adva cemert of the GuideLmer”“‘.
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`‘9?wn
`‘ Shonid the arm ‘ {mar the mummy gm“
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`the CuidetinerN as secondary ‘
`tray wrat) armr‘d the
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`3aéchincr“"-” ;
`3‘ tut); obstpgtirg 5t~crtt ir‘s<3t‘:.50"r,
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`in case of re ‘ Ence write inserting a guidewrs er stem:
`the Gurrjeijner‘”, as ‘Gcatror at he w r? o stem Sr re‘atimsmp
`To the meta} enter at The (amdet :ner'M SETIUM be checked and
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`the stem: inspecte; far Sigrs 0f dame e grim to re,
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`thatgccursafiorv _ imartQL‘tho COL. "
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`.3, Ensure «I e :3 .oination of me wire and stem: is :c-r-matibte
`M“ *m: intema d-emeter ofthe (5r idei'rter W
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`:iary wire is zrr USE, «t
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`15660“
`'wire arou’d :he GuideLinerT“. if so w my eiaher
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`primary wwe (paced bet
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`ptace cm: der ecvamng the start over the primary we.
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`if a giant cantimes to enCQLJnt-er resistanc at the met,
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`e 36 cm and 2:3; ze—put: the 31m: and gudewive back t:
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`acvariing the 5 mt a, ;
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`of damage
`r Mtge the gm swire
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`«fewer/”R We mortars/i Gsfldeuner
`figure 2’ enserfl'an 3f fhe
`catheter is rnsertez’ mo 3 g ding Cathie! over a guisem’e (SW) {1).
`ONCE ads/areas! into five guidmg caffiefer.
`the SUideLr‘ner push tube
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`(limits! exgaerience
`cgr’ be Edi/awed urhé‘s‘ holding the G W in macs (ii). The Gu‘rfmjner
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`can he advert t .d up to 70 cm beyond me g "d b
`fer min (;
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`5‘ ’4 yearold oajc—nt W h “MOUS 00m“
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`Baltic-07:5 0' starts (5? car as advanced 3/0ng the guidewire {
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`(LAD)andatightstenos‘s‘rihE Circurrf’iax ost'urr.Th& grafimthe LAC
`was occluc’ed 3x {here was a patent jump graft to an Ciiuse margifial
`and :Ostefiar descending artery; The right coronary artery (RCA) was
`hm
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`wfwmd t:
`"‘mwc‘iy using a 6 Fr awatl” ‘
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`Tamera! may: Init‘aT'y a wockey stick guflng cat
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`EiiiA weathen Wired u< r-g a BMW wire {Abba-“r \f
`CA, LEA ) an: pre'czlated wi‘rh a ’25 )1 L5 Maverxck méimn (Bos‘rcn
`Sciemfic, Nam, MA, USA) figures 3c am SO}. Hmeve, due: to a
`commazion of CC
`‘ficaiicn ant tortuosit-g. a stem some not be deiive'ed‘
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`After gutthex' @3300 with a 303 15 mm Maverick balhxun,
`it was 5m:
`impossible to acvance a stem. There*0r'e. a GudeLiner’“ CBTI‘S’BF was
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`flamed No the T»
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`deployed through the ALT gude and
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`n delwety (Figw’e Be). This enabhsd we easy depio,.nem o $qu
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`overTapymg drug—»,Tu 5 51‘:
`t’ Tom W” m"“VCS°CI
`t” the 0°: W
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`(3.5 x 15 mm.
`L8 mm, 35:23 mn‘ am 3.3;;8 Win; 312 Prm v5;
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`Boston Scie
`(3, Mick, MA, USA)_ The, overtaps were UQSMTIETQC wit?"
`a 3 5x8 rr‘rri nozHprhan‘i mzm: (Guamur‘: Maw-tuck; Basin!“
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`and flame” with a 4 :48 'nm non‘ccmpiiam 331'
`. ar‘mm Mave’ick;
`w?
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`sxus
`Ecgon 309T t: m, N {Us MFA, Lol‘x}
`T 3 Cd a £09?me re
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`va
` '9 3f}. The patent was damaged the fUI=owing day with
`acmeved (Fig
`no mmphcamns.
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`CW CCTV? W55 :mpoesibic (£05333 “‘3 v59 0T ’3
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`:g the GuideL‘nerTV‘, if?portive guiding caihete By
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`sien: was cepioyed e
`y and EL:
`siully becausg of the extra,
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`back 1m “ 1mm and
`a mmbaiim Anthem any «:isplacemenf of
`
`the guide Latr’xtier or she wire or any vessel :x'aumaT
`
`a 78W alternatwe for Den‘orming
`The CudeLinsr’M arm/ids
`l’IcTudez
`ccmpiex intewentiona. Ben:
`1. Deco seating with a 5t"aig‘»':i, higfly flexblc guice extension
`7 Unl’e deep intubation of a guijmg :a hater. these ’3 no array
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`' the vessel.
`‘vz'veio paientellydamageand digs
`7 Coil bi: bone ps’ovdos SUPCHC” floxxbwiy whi @- vtaining t’adiai
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`strength.
`Ix). The Jewce any ieduce° ihe Tu’new by azprox-rreteiy one French
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`Wm gm: fig through 3 5 D Gunginer'M
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`Seyman? Thrmgh The
`PVTS’THQ
`{3 9mm nge alas
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`ah. valve whim e
`ndifig ‘he gaming whet? k.— ¥
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`afd 3-0 30.33 wt m” the Lsaulo ‘cngih mt bazjafjpg and wins
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`LA.
`
`References
`
`
`1
`ifar‘yl—h‘x’x’hen onewor’temg usemcmoqbie“tuficyflwngm
`
`
`Tamale stem advan/ mam amass a Zr’zag'iy (:55
`{zed aria; (Lawyer
`Camiomsr Wary 20.16.67.72173.
`2. Takahasm 8, Saw 8 Ta
`- Y, Shtono T, A71? F.
`
`Domae H. Safer
`Imh T New rr
`Jease c bacvur
`“ rt nf
`
`
`
`,
`.T
`;
`r-
`n
`
`
`
`a b Harm gmmg caranary (a '66“ catheter bammm We”,
`2034;63:452 a,
`.
`T
`.
`.
`h
`.
`3. Sr‘aklkaT n A-BUSLaH M Oilg PJ, Jim-‘1“?IUIdTUCCW‘éTUF—“Jbé‘ QT
`
`6 5 French g
`:g catheter in a 6 French guiding catheter. J InvasJJE
`Cardio’ 2008103178.
`e’i Mamas MA Fem—Crdmbadi S, Fraae’ D Succefis‘u! use of We
`Heaman m catheter as a stem deiivery catheter $0340“!ng failure 0* cm—
`
`vermonef 'PUTF'TQUBS. Caflzsier Czirwovaus Mew 2008:7135
`
`* MET—Or arm “
`
`flcarzra‘ T= Cb.
`
`I detivem device an eflemed Case series Euro Rweflbm
`._
`£009;5,?65—71.
`
`
`
` Q
`
`\
`" giogram of the rv'gm carowary emery {c} Using an Amp/at: Left 1 guide, We
`. a; '
`Figure 3. cubical use a? the Gm
`
`fesions were crossed with a BMW wire. {(1) The resigns wow 0700;13th but a sfenf could no? be: aavanced,
`{C} The GuideLifich {anew} was
`
`advanced [In to the his/an f0 allaw depioyment of the sfenf (arrowhead). (1‘; Final angrograr fa resuft
`
`ww’
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`10C1817_EIJ28_TAP60_R80 30/06/10 18:35 P699280
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`, , § , ,
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`ML2259 rev A 07/10
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`VSIQXM_E00044478
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`Page 4
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`Teleflex Ex. 2067
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