`
`
`GUIDELINER® CATHETER
`
`GuideLiner Catheter Facilitates
`
`
`ea":m‘e nt of Calcific 05":ial
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`‘rcum'l x Art ry dcspi .e Sever
`
`
`
`
`“tr a" mu an
`
`
`
`
`
`
`
`
`
`
`
`
`
`PHYSICIAN
`
`Barry S. Weinstock, MD, FACC
`South Lake Hospital, Clermont, Florida
`
`PRESENTATION
`
`The patient is a woman with extensive cardiovascular history
`including prior CABG, porcine aortic valve replacement,
`chronic atrial fibrillation with AV node failure and subsequent
`permanent pacemaker placement. She also has hypertenstion,
`diabetes and a history of stroke. Due to severe left hip pain
`from degenerativejoint disease, she was electively admitted
`for total hip arthroplasty. Post—operatively, she developed
`congestive heart failure and cardiac enzymes were consistent
`with a small peri-operative myocardial infarction. Cardiac
`catheterization was advised for further evaluation of her
`cardiac status.
`
`INITIAL FINDINGS
`
`The patient underwent diagnostic catheterization (Figure 1)
`which demonstrated a patent left main coronary artery without
`significant disease. The left anterior descending artery had
`severe disease proximally with competitive flow from a bypass
`graft noted distal to the origin ofa patent diagonal branch,
`which itself had severe ostial segment stenosis of 80-90%.
`The left circumflex artery had severe proximal tortuosity with
`retroflexion and a critical 95% stenosis at the origin followed
`by moderately severe disease proximally. A large lst obtuse
`marginal branch had 70% proximal stenosis while a small 2nd
`obtuse marginal branch had 90% ostial segmental stenosis.
`The RCA had diffuse disease. The LIMA graft to the LAD was
`normal but all of the saphenous vein grafts were occluded. LV
`function was remarkably well preserved with EF of55% with no
`significant wall motion abnormality. The culprit lesion for her
`MI was thought to be the critical ostial left circumflex stenosis
`and the patient was referred for intervention.
`
`TREATMENT
`
`The ostial circumflex stenosis was approached using a 7F
`XB 3.5 guide catheter and the patient was anti-coagulated
`with bivalirudin. The circumflex was initially wired using a
`0.014" Hi-Torque Whisper extra-support guidewire. The ostial
`stenosis was dilated using a 3.0 x 15mm Trek® PTCA balloon.
`A Promus® 4.0 x 28mm drug-eluting stent was inserted, but
`could be advanced only partially into the circumflex despite
`aggressive guide catheter positioning. The stent was removed
`and additional angioplasty was performed using a 3.5 x 20mm
`Apex® balloon catheter.
`
`{continued on back)
`
`Page 1
`
`VSIQXM_EOOO44658
`
`Teleflex Ex. 2186
`
`Medtronic v. Teleflex
`
`
`Page 1
`
`Teleflex Ex. 2186
`Medtronic v. Teleflex
`
`
`
`
`
`
`
`
`
`Barry S. Weinstock, MD, FACC
`Dr. Weinstock trained at Yale School of Medicine
`before completing his residency in internal medicine
`at the Hospital ofthe University of Pennsylvania.
`He completed his cardiology fellowship at Cedars—
`Sinai Medical Center and has been in practice as an
`interventional cardiologist since 1993. He currently
`practices with Mid—Florida Cardiology Specialists in
`Orlando and performs interventional procedures at
`three hospitals in the central Florida area.
`
`Tfiéfiimgfi? {messages};
`A second 0.014”Cho|CE® PT Extra Support guidewire was
`delivered and the stent was re-advanced over the ChoICE
`
`PT wire. Again, it was not possible to pass the stent into the
`circumflex despite “deep—th roating" the guide catheter. The
`first guidewire was removed, and a 7F-compatible GuideLiner
`was advanced without difficulty to the proximal circumflex
`artery. The 4.0 x 28mm stent was then advanced easily into
`the circumflex and the GuideLiner was removed. The stent
`
`was positioned at the ostium ofthe vessel and deployed. The
`1st OM branch was then dilated using a 3.0 x 20mm Apex
`angioplasty balloon catheter which resulted in a moderate
`dissection. An attempt was made to pass a 3.0 x 23mm
`Promus stent into the OM branch but the stent would not
`
`pass through the ostial circumflex stent due to interaction
`with the stent struts. The stent was removed and the
`
`GuideLiner was re-advanced to the mid-circumflex artery. The
`3.0 x 23mm Promus stent was then easily advanced into the
`OM branch and deployed.
`
`n
`
`Additional views of the left main coronary artery revealed
`mid-distal dissection, likely due to aggressive "deep-throating
`of the guide catheter. The GuideLiner was re—advanced to
`the proximal circumflex and a 4.0 x 18mm Promus stent
`was advanced to the left main coronary artery with overlap
`distally into the ostial circumflex stent and deployed.The
`GuideLiner was removed and the left main artery and ostial
`/ proximal circumflex were post—dilated using a 5.0 x 12mm
`NC Quantumm‘ Apex balloon catheter. Final angiography
`confirmed excellent angiographic results in the left main,
`circumflex and first OM branch (Figure 2). The severe disease
`at the ostium ofthe small second OM branch was not treated.
`
`SUMMARY
`
`This patient had failure ofall but one bypass graft and was
`extremely close to acutely occluding a large circumflex
`artery at its origin. The vessel's tortuosity, retroflexion and
`calcification combined to make stenting virtually impossible,
`despite use ofa very strong guide catheter position and
`two extra-support wires. Using the GuideLiner device, it was
`possible to stent the ostial / proximal circumflex, a large OM
`branch after a balloon
`
`angioplasty—induced dissection, and the protected left main
`coronary artery with highly important overlap ofthe ostial
`circumflex stent. This challenging case highlights the utility
`of the GuideLiner, a device which clearly was the difference
`between this procedure's failure and success.
`
`GuideLinercatheters areintended to be used in conjunction with guide catheters to access discrete regions ofthe coronary
`and/orperipheralvasculature, and tofaciiitateplacementand exchange ofguideWires and otherinterventionaldevices.
`Pieasesee the lnstructionsfor Use fora complete listing ofthe indications, contraindications, warnings and precautions.
`CAUTION: Federal law (U.S.A.) restricts this deviceto sale by or on theorder of a physician.
`GuideLiner is a registered trademarkofVascuiarSolutions, Inc.
`All otliertrademarks and registered trademarks are property oftlieir respective owners.
`©2016VascularSolutions, |nc.All rights reserved.MLz411 Rev. B 10/16
`
`-
`
`-
`.
`-
`: : ::
`y
`_
`J. x u u
`.
`‘ .
`.
` __.,..
`: u u' u r
`
`aSCular
`S 0 L U 'I‘
`I U N S
`
`VascularSqutions,|nc.
`6464 Sycamore Court North
`Minneapolis Minnesota 55369 USA
`'
`-
`.
`Customer Service:
`UhltEd States. 8882405001
`International: (001) 763.656.4298
`customerservice@vasc.com
`www.vasc.com
`
`Page 2
`
`VSIQXM_EOOO44659
`
`Teleflex Ex. 2186
`
`Medtronic v. Teleflex
`
`
`Page 2
`
`Teleflex Ex. 2186
`Medtronic v. Teleflex
`
`