NOW APPROVED
`WITH AN
`AUI INDICATION
`
`Innovating for life.
`
`Page 1
`
`IPR2014-00100 Pat. Owner Ex. 2029
`Medtronic v. Marital Deduction Trust
`
`

`
`F R O M T H E E V E R Y D AY
`T O T H E E X T R A O R D I N A R Y
`
`Endurant II extends the proven performance of Endurant with a lower profile,* additional
`limb lengths and enhanced visibility. With all the deliverability, conformability and range of
`its predecessor—and with even more options for clinical success, including an aorto-uni-iliac
`device—Endurant II empowers stronger results for more patients.
`
`Low-profile, hydrophilic
`delivery system for
`enhanced access
`
`The only device with an
`FDA-approved AUI indication†
`
`Longer limb lengths
`offer multiple options
`
`Improved radiopacity for
`increased visibility‡
`
`* 28 mm aortic stent graft
`† FDA Premarket Approval Database. No results post query, as of 4/13.
`‡ Contralateral gate marker
`
`2
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`E N D U R A N T I I A A A S T E N T G R A F T S Y S T E M
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`Page 2
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`IPR2014-00100 Pat. Owner Ex. 2029
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`
`

`
`Controlled release
`
`High-density,
`multifilament polyester
`graft material
`
`Single-piece, laser-cut
`nitinol stent with anchor
`pins for suprarenal fixation
`
`Tip capture for
`accurate deployment
`
`3
`
`Page 3
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`
`

`
`LO W E R P R O F I L E
`E N H A N C E D A CC E S S
`
`Endurant II takes improved access a step further, offering an 18 F crossing
`profile across most bifurcated devices.* With an extended hydrophilic
`coating, and the same thin-walled graft cover and flexible, kink-resistant
`delivery system as Endurant, Endurant II delivers even more ease-of-use
`across a broad anatomical range.
`
`B I FU R C AT ED A A A D E V I CE O U T ER D IA M E T ER PR O FI L E S
`
`28 mm Medtronic Endurant II, Endologix AFX, Cook Zenith and 28.5 mm Gore Excluder
`
`Medtronic
`Endurant II
`
`Endologix
`AFX
`
`Gore
`Excluder
`
`Crossing Profile (OD)
`Hydrophilic Coating
`Sheath Required
`
`18 F
`Yes
`No
`
`19 F1
`Yes
`Yes
`
`20 F2
`No
`Yes
`
`Cook
`Zenith
`
`23 F 3
`Yes
`Yes
`
`* 18 F outer diameter in 28, 25 and 23 mm bifurcations, AUI and aortic extensions; 20 F in 36 and 32 mm bifurcations, AUI and aortic extensions.
`
`4
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`E N D U R A N T I I A A A S T E N T G R A F T S Y S T E M
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`Page 4
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`IPR2014-00100 Pat. Owner Ex. 2029
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`
`

`
`99.3%delivery/deployment
`
`success4
`
` d o w n
`
`t h e r
`
`f u r
`
`i n g e x t e n d s 5 3 %
`
`H y d r o p h i
`
`i c c o a t
`
`l
`
`BIFUR AND AUI DIAMETER
`
`28mm, 25 mm, 23 mm
`
`36mm, 32 mm
`
`18 F (OD)*
`
`20 F (OD)*
`
`LIMB DIAMETER
`
`16mm, 13mm, 10mm†
`
`28mm, 24 mm, 20 mm
`
`e r y
`
`e li v
`
`f t d
`
`a
`
`r
`
`n t g
`
`e
`
`t
`
`e s
`
`i l i t a t
`
`t h a n E n d u r a n t t o f a c
`
`PEVAR
`
`compatible4
`
`14 F (OD)*
`
`16 F (OD)*
`
`* Outer diameter
`† All 156 and 199 mm limbs are 16 F
`
`1. Per Endologix presentation, main body device at 19 F includes sheath. Data on file at Medtronic, Inc.
`
`2. Bench test data on file at Medtronic, Inc. Bench test data may not be indicative of clinical performance. The Gore Excluder IFU recommends using an
`18 F Gore Introducer Sheath with its 28.5 mm Gore Excluder bifurcated main body device. The Gore DrySeal Sheath IFU indicates that the nominal OD of an
`18 F Gore DrySeal Sheath is 6.8 mm, which is 20.4 F.
`
`3. Bench test data on file at Medtronic, Inc. Bench test data may not be indicative of clinical performance. Cook’s Physician Manual indicates that the
`OD of a 28 mm Cook Zenith bifurcated main body device is 7.7 mm, which is 23.1 F.
`
`4. Delivery success = successful vascular access and delivery of the device to the intended anatomical treatment site. Deployment success = successful
`deployment of the device in the intended site and the successful removal of the delivery system. Endurant US IDE trial: Makaroun M. One-year outcomes of
`the US regulatory trial of the Endurant stent graft system. J Vasc Surg. 2011; 54:601-608.
`
`5. Percutaneous access and closure techniques may be used in conjunction with Endurant and Endurant II for patients having adequate iliac/femoral access.
`
`5
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`Page 5
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`IPR2014-00100 Pat. Owner Ex. 2029
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`
`

`
`COMPLETE CONFORMABILITY
`OPTIMAL SEAL
`
`In treating anatomies both simple and daunting, conformability and seal
`promote success. With super-elastic nitinol stents, Endurant II conforms to
`tortuous iliac arteries and highly angulated necks. For patients requiring
`an aorto-uni-iliac, Endurant II is the only device with an FDA-approved
`AUI indication.*
`
`1. M-shaped proximal stents provide wall
`apposition and minimize infolding
`
`2. Limb stent and spacing
`between stents conform to
`anatomy to reduce kinking
`
`* FDA Premarket Approval Database. No results post query, as of 4/13.
`
`6
`
`2
`
`E N D U R A N T I I A A A S T E N T G R A F T S Y S T E M
`
`Page 6
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`IPR2014-00100 Pat. Owner Ex. 2029
`Medtronic v. Marital Deduction Trust
`
`

`
`PRE
`
`POST
`
`Pre-procedure and one-month follow-up
`of Endurant AAA stent graft. Results
`may vary.
`
`Treat necks as
`
`short as 10mm
`60°
`
`and angulation up to
`
`1
`
`Type 1 Endoleak
`
`0%†
`
`At 2 Years
`
`† 2011 Endurant Clinical Update
`
`7
`
`Page 7
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`
`

`
`CO N S I S T E N T P R E C I S I O N
`CO N T R O L L E D D E P LOYM E N T
`
`An advanced delivery system makes Endurant II simple to place. With control
`at every step, you can approach more targets with confidence.
`
`A backend thumb wheel provides controlled release
`of the suprarenal stent and anchor pins.
`
`Aim accurately with four proximal markers
`
`Easy contralateral limb placement with the flow divider marker
`
`Facilitate gate cannulation with improved
`radiopacity of contralateral gate marker
`
`8
`
`E N D U R A N T I I A A A S T E N T G R A F T S Y S T E M
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`Page 8
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`IPR2014-00100 Pat. Owner Ex. 2029
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`
`

`
`Tip capture for
`precise positioning
`adjustments, including
`adjustment of placement
`proximally or distally, even
`after deployment of
`three stent rings.*
`
`e-shaped marker assists
`with A/P orientation
`
`* Please refer to the product Instructions for Use for details.
`
`9
`
`Page 9
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`IPR2014-00100 Pat. Owner Ex. 2029
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`
`

`
`D U R A B L E D E S I G N
`D E P E N D A B L E P E R F O R M A N C E
`
`Featuring a suprarenal stent with anchor pins laser-cut from a single piece of nitinol
`and high-density polyester graft material, Endurant II is built for durability, with the
`quality you’ve come to expect.
`
`1. High-density, multifilament
`polyester graft material
`provides lower porosity
`for resistance against
`aneurysm sac growth
`
`2. Ultra-high molecular
`weight polyethylene
`sutures are three
`times stronger than
`surgical sutures
`
`1
`
`10
`
`E N D U R A N T I I A A A S T E N T G R A F T S Y S T E M
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`Page 10
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`IPR2014-00100 Pat. Owner Ex. 2029
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`
`

`
`Suprarenal stent
`with anchor
`pins provides
`secure fixation
`
`3
`
`2
`
`BEFORE
`POLISHING
`
`AFTER
`POLISHING
`
`3. Electropolished
`nitinol stent for
`greater strength
`
`0%*
`
`Migration at 2 Years
`
`*
`
` Proximal migration is observed when the stent graft covers a renal artery or moves > 10 mm.
`Distal migration is observed when the graft moves > 10 mm relative to fixed anatomic
`landmarks. 2011 Endurant Clinical Update.
`
`11
`
`Page 11
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`
`

`
`M E A S U R E D I N R E S U LT S
`CLINIC AL DISTINC TION. TRIAL AFTER TRIAL.
`
`The most comprehensive abdominal aortic clinical program,
`with over 1,500 patients worldwide1
`
`Completed Follow Up (Yrs)1
`
`1 YEAR 44
`
`US IDE - AUI ARM
`
`1 YEAR
`
`2 YEARS
`
`80
`
`EU TRIAL
`
`150
`
`US IDE
`
`2 YEARS: N=500
`
`ENROLLMENT
`COMPLETED
`
`ENROLLMENT
`COMPLETED
`
`1,263
`
`ENGAGE
`Global Post-
`Market Registry
`
`178
`
`180
`
`ENGAGE US
`
`ENDURANT FRANCE
`
`Setting the standard for global clinical evidence for EVAR
`1 out of 2 EVAR patients worldwide receives an Endurant Stent Graft2
`
`Trials and registry evaluated the Endurant Stent Graft System.
`
`1. Data on file at Medtronic.
`
`2. BOXI data as of March 16, 2012.
`
`12
`
`E N D U R A N T I I A A A S T E N T G R A F T S Y S T E M
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`Page 12
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`IPR2014-00100 Pat. Owner Ex. 2029
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`

`
` ENDURANT DELIVERS CONSISTENT CLINICAL PERFORMANCE IN BOTH CONTROLLED TRIALS AND
`REAL-WORLD REGISTRIES
`
`1-Year Results: E(cid:31)ectiveness Endpoints1
`
`AAA DIAMETER
`INCREASE
`
`RUPTURE
`POST IMPLANT
`
`TYPE I
`ENDOLEAK
`
`STENT GRAFT
`MIGRATION
`
` 0%
`
`ENGAGE
`(N = 1,263)
`7% treated
`with an AUI 3
`
`US IDE
`(N = 150)
`
`EU TRIAL
`(N = 80)
`
`US IDE -
`AUI Arm
`(N=44)
`
`3.9%
`
`0.7%
`
`2.7%
`
`0%
`
`DURABLE CLINICAL PERFORMANCE: ENGAGE REGISTRY 2 YEAR DATA
`
`ENDURANT DEMONSTRATES MARKERS FOR EVAR DURABILITY
`
`98.1% freedom from aneurysm-related mortality
`56% of aneurysm sacs decreased >5mm4
`Low 1.1% Type I/III endoleak rate
`
`3. 84 ENGAGE patients were treated with an Endurant AUI.1-Year results were 0% AAA Diameter Increase, 0% Rupture Post Implant, 0% Type I Endoleak and 0%
`Stent Graft Migration.
`
`4. Versus 41% at year 1
`ENDURANT EU trial: Rouwet EV et al. Eur J Vasc Endovasc Surg. 2011;42(4):489–497.
`
`
`
`
`
`
`
`13
`
`3.9%
`
`0.7%
`
`2.7%
`
`0%
`
`Page 13
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`IPR2014-00100 Pat. Owner Ex. 2029
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`
`

`
`CO M P O N E N T P L A C E M E N T G U I D E
`
`o x I M AL MARk
`
`ER s
`
`AUI p R
`
`23, 25, 28,
`32, 36 mm
`
`ThE ONLY
`DEVICE WITh AN
`FDA-approved
`AUI indication†
`
`D p R oxIMAL M
`
`A R k
`
`E
`
`R s
`
`23, 25, 28,
`32, 36 mm
`
`cA T E
`
`BIFUR
`
`s I o N pRoxIM
`
`AL M
`
`A R kERs
`
`23, 25, 28,
`32, 36 mm
`
`TE N
`
`AoRTIc Ex
`
`AUI GRAFT
`
`102 mm
`
`ALIGN MARk ERs
`
`L A TERAL L
`
`I M
`
`B **
`
`s
`
`16 mm
`
`AL M A R kER
`
`R A
`
`coNT
`
`p
`
`R
`
`o xIM
`
`L ATERA
`L
`
`LI M B
`
`16 mm
`
`s
`
`AL M A R kER
`
`R A
`
`coNT
`
`p
`
`R
`
`sTENT ovERLAp
`
`MINIMUM 3
`
`o xIM
`
`23, 25, 28,
`32, 36 mm
`
`ILIA c E x TENsI
`
`o
`
`N
`
`12,
`14 mm
`
`14 mm
`
`AoRTIc ExTENsIoN
`
`49, 70 mm
`
`70*, 80 mm
`
`40*, 50 mm
`
`BIFURcATED GRAFT
` 124*, 145, 166 mm
`
`o xIM
`
`coNTRALATERAL LIMB**
`82, 93, 124, 156, 199 mm
`
`coNTRALATERAL LIMB
`82, 93, 124, 156, 199 mm
`
`13, 16,
`20 mm
`
`sTENT ovERLAp
`
`MINIMUM 3
`
`10, 13,
`20, 24,
`28 mm
`
`ILIAc ExTENsIoN
`
`82 mm
`
`Radiopaque markers
`
`DIsTINcT RADIopAqUE MARkERs
`•
`•
`e-shaped proximal markers
`— Internal ring marker—only seen under fluoroscopy
`
`* Measurements for 124 mm length bifurcated stent graft
`
`** The contralateral iliac limb mates with the AUI stent graft on
`the ipsilateral side.
`
`10, 13,
`16, 20, 24,
`28 mm
`
`10, 13,
`16, 20, 24,
`28 mm
`
`† FDA Premarket Approval Database. No results post query, as of 4/13.
`
`14
`
`p
`
`R
`
`10, 13,
`20, 24,
`28 mm
`
`s
`
`AL M A R kER
`
`E N D U R A N T I I A A A S T E N T G R A F T S Y S T E M
`
`Page 14
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`IPR2014-00100 Pat. Owner Ex. 2029
`Medtronic v. Marital Deduction Trust
`
`

`
`E N D U R A N T I I P R O D U C T CO D E S
`
`B I FU Rc A T Io N s
`Pro duc t Co de
`
`co N T R A L AT E R A L I L I Ac L I M Bs §
`Pro duc t Co de
`
`Proximal
`Graft
`Diameter
`(mm)
`
`Distal
`Graft
`Diameter
`(mm)
`
`Distal
`Design
`
`Total
`Covered
`Length
`(mm)
`
`Delivery
`System
`
`Catheter
`Outer
`Diameter
`(F)
`
`Proximal
`Graft
`Diameter
`(mm)
`
`Distal
`Graft
`Diameter
`(mm)
`
`Distal
`Design
`
`Total
`Covered
`Length
`(mm)
`
`Delivery
`System
`
`Catheter
`Outer
`Diameter
`(F)
`
`Total
`Contralateral
`Covered Length
`with Bifurcated‡
`
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`ETBF
`
`23
`23
`23
`23
`23
`23
`25
`25
`25
`25
`25
`25
`28
`28
`28
`28
`28
`28
`28
`28
`28
`32
`32
`32
`32
`32
`32
`36
`36
`36
`36
`
`AU I
`
`Proximal
`Graft
`Diameter
`(mm)
`23
`25
`28
`32
`36
`
`ETUF
`ETUF
`ETUF
`ETUF
`ETUF
`
`13
`13
`13
`16
`16
`16
`13
`13
`13
`16
`16
`16
`13
`13
`13
`16
`16
`16
`20
`20
`20
`16
`16
`16
`20
`20
`20
`16
`16
`20
`20
`
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`
`124
`145
`166
`124
`145
`166
`124
`145
`166
`124
`145
`166
`124
`145
`166
`124
`145
`166
`124
`145
`166
`124
`145
`166
`124
`145
`166
`145
`166
`145
`166
`
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`
`18
`18
`18
`18
`18
`18
`18
`18
`18
`18
`18
`18
`18
`18
`18
`18
`18
`18
`18
`18
`18
`20
`20
`20
`20
`20
`20
`20
`20
`20
`20
`
`Distal
`Design
`
`Pro duc t Co de
`Distal
`Graft
`Diameter
`(mm)
`14
`14
`14
`14
`14
`
`C
`C
`C
`C
`C
`
`Total
`Covered
`Length
`(mm)
`102
`102
`102
`102
`102
`
`Delivery
`System
`
`E
`E
`E
`E
`E
`
`Catheter
`Outer
`Diameter
`(F)
`18
`18
`18
`20
`20
`
`I L I Ac E xT E N s I o N s
`Pro duc t Co de
`
`Proximal
`Graft
`Diameter
`(mm)
`
`Distal
`Graft
`Diameter
`(mm)
`
`Distal
`Design
`
`Total
`Covered
`Length
`(mm)
`
`Delivery
`System
`
`Catheter
`Outer
`Diameter
`(F)
`
`ETEW
`ETEW
`ETEW
`ETEW
`ETEW
`
`10
`13
`20
`24
`28
`
`10
`13
`20
`24
`28
`
`C
`C
`C
`C
`C
`
`82
`82
`82
`82
`82
`
`E
`E
`E
`E
`E
`
`14
`14
`16
`16
`18
`
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`ETLW
`
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`
`10
`10
`10
`10
`10
`13
`13
`13
`13
`13
`16
`16
`16
`16
`16
`20
`20
`20
`20
`20
`24
`24
`24
`24
`24
`28
`28
`28
`28
`28
`
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`
`82
`93
`124
`156
`199
`82
`93
`124
`156
`199
`82
`93
`124
`156
`199
`82
`93
`124
`156
`199
`82
`93
`124
`156
`199
`82
`93
`124
`156
`199
`
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`
`14
`14
`14
`16
`16
`14
`14
`14
`16
`16
`14
`14
`14
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`16
`
`136
`147
`178
`210
`253
`136
`147
`178
`210
`253
`136
`147
`178
`210
`253
`136
`147
`178
`210
`253
`136
`147
`178
`210
`253
`136
`147
`178
`210
`253
`
`‡ These calculations assume the minimum 30 mm overlap between the bifurcated
`stent graft and the contralateral iliac limb per the Endurant II Stent Graft System
`Instructions for Use. When using the 124 mm length bifurcated stent graft, subtract 10 mm
`from Total Contralateral Covered Length with Bifurcated.
`
`§ The contralateral iliac limb mates with the AUI stent graft on the ipsilateral side.
`
`Ao R T Ic E xT E N s I o N s
`Pro duc t Co de
`
`Proximal
`Graft
`Diameter
`(mm)
`
`Distal
`Graft
`Diameter
`(mm)
`
`Distal
`Design
`
`Total
`Covered
`Length
`(mm)
`
`Delivery
`System
`
`Catheter
`Outer
`Diameter
`(F)
`
`ETCF
`ETCF
`ETCF
`ETCF
`ETCF
`ETTF
`ETTF
`ETTF
`ETTF
`ETTF
`
`23
`25
`28
`32
`36
`23
`25
`28
`32
`36
`
`23
`25
`28
`32
`36
`23
`25
`28
`32
`36
`
`C
`C
`C
`C
`C
`C
`C
`C
`C
`C
`
`49
`49
`49
`49
`49
`70
`70
`70
`70
`70
`
`E
`E
`E
`E
`E
`E
`E
`E
`E
`E
`
`18
`18
`18
`20
`20
`18
`18
`18
`20
`20
`
`15
`
`Page 15
`
`IPR2014-00100 Pat. Owner Ex. 2029
`Medtronic v. Marital Deduction Trust
`
`

`
`evaluated in some patient populations. Please refer to the product Instructions for Use
`for details.
`
`MRI Safety and Compatibility: Non-clinical testing has demonstrated that the Endurant
`II Stent Graft is MR Conditional. It can be scanned safely in both 1.5T & 3.0T MR systems
`under certain conditions as described in the product Instructions for Use. For additional
`information regarding MRI please refer to the product Instructions for Use.
`
`Adverse Events
`Potential adverse events include (arranged in alphabetical order): amputation;
`anesthetic complications and subsequent attendant problems (e.g. aspiration),
`aneurysm enlargement; aneurysm rupture and death; aortic damage, including
`perforation, dissection, bleeding, rupture and death; arterial or venous thrombosis and/
`or pseudoaneurysm; arteriovenous fistula; bleeding, hematoma or coagulopathy; bowel
`complications (e.g., ileus, transient ischemia, infarction, necrosis); cardiac complications
`and subsequent attendant problems (e.g. arrhythmia, myocardial infarction, congestive
`heart failure, hypotension, hypertension); claudication (e.g., buttock, lower limb);
`death; edema; embolization (micro and macro) with transient or permanent ischemia
`or infarction; endoleak; fever and localized inflammation; genitourinary complications
`and subsequent attendant problems (e.g., ischemia, erosion, femoral-femoral artery
`thrombosis, fistula, incontinence, hematuria, infection); hepatic failure; impotence;
`infection of the aneurysm, device access site, including abscess formation, transient
`fever and pain; lymphatic complications and subsequent attendant problems (e.g.,
`lymph fistula); neurologic local or systemic complications and subsequent attendant
`problems (e.g., confusion, stroke, transient ischemic attack, paraplegia, paraparesis,
`paralysis); occlusion of device or native vessel; pulmonary complications and
`subsequent attendant problems; renal complications and subsequent attendant
`problems (e.g., artery occlusion, contrast toxicity, insufficiency, failure); stent graft:
`improper component placement; incomplete component deployment; component
`migration; suture break; occlusion; infection; stent fracture; graft twisting and/or
`kinking; insertion and removal difficulties; graft material wear; dilatation; erosion;
`puncture and perigraft flow; surgical conversion to open repair; vascular access site
`complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous
`fistula, dissection; vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection,
`bleeding, rupture, death); vessel damage; wound complications and subsequent
`attendant problems (eg, dehiscence, infection, hematoma, seroma, cellulitis)
`
`Please reference product Instructions for Use for more information regarding indications,
`warnings, precautions, contraindications and adverse events.
`
`CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
`
`UC201201590a EN © Medtronic, Inc. 2013. All rights reserved. Printed in USA. For distribution in the USA only. 5/13
`
`Indications
`The Endurant® II bifurcated stent graft is indicated for the endovascular treatment of
`infrarenal abdominal aortic or aorto-iliac aneurysms. The Endurant II aorto-uni-iliac (AUI)
`stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or
`aortoiliac aneurysms in patients whose anatomy does not allow the use of a bifurcated
`stent graft. The Endurant II stent graft system is indicated for use in patients with the
`following characteristics:
`• Adequate iliac/femoral access that is compatible with vascular access techniques,
`devices and/or accessories
`• Proximal neck length of ≥10 mm
`•
`Infrarenal neck angulation of ≤60°
`• Aortic neck diameters with a range of 19 to 32 mm
`• Distal fixation length(s) of ≥15 mm
`•
`Iliac diameters with a range of 8 to 25 mm
`• Morphology suitable for aneurysm repair
`
`Contraindications
`The Endurant II Stent Graft System is contraindicated in:
`• Patients who have a condition that threatens to infect the graft.
`• Patients with known sensitivities or allergies to the device materials.
`
`•
`
`Warnings and Precautions
`•
` The long-term safety and effectiveness of the Endurant II Stent Graft System has not
`been established. All patients should be advised that endovascular treatment requires
`lifelong, regular follow-up to assess the health and the performance of the implanted
`endovascular stent graft. Patients with specific clinical findings (e.g., endoleaks,
`enlarging aneurysms or changes in the structure or position of the endovascular graft)
`should receive enhanced follow-up. Specific follow-up guidelines are described in the
`Instructions for Use.
` Patients experiencing reduced blood flow through the graft limb, aneurysm expansion,
`and persistent endoleaks may be required to undergo secondary interventions or
`surgical procedures.
` The Endurant II Stent Graft System is not recommended in patients unable to undergo
`or who will not be compliant with the necessary preoperative and postoperative
`imaging and implantation studies as described in the Instructions for Use.
` Renal complications may occur: 1) From an excess use of contrast agents. 2) As a result
`of emboli or a misplaced stent graft. The radiopaque marker along the edge of the stent
`graft should be aligned immediately below the lower-most renal arterial origin.
` Studies indicate that the danger of micro-embolization increases with increased
`duration of the procedure.
` The safety and effectiveness of the Endurant II Stent Graft System has not been
`
`•
`
`•
`
`•
`
`•
`
`www.medtronic.com
`www.aortic.medtronicendovascular.com
`Medtronic Vascular, Inc.
`Product Services
`Support Center
`3576 Unocal Place
`Santa Rosa, CA 95403
`Tel: 888.283.7868
`USA
`Fax: 800.838.3103
`
`CardioVascular LifeLine
`Customer Support
`Tel: 877.526.7890
`Tel: 763.526.7890
`
`Page 16
`
`IPR2014-00100 Pat. Owner Ex. 2029
`Medtronic v. Marital Deduction Trust