AF1468EN1.EXCB.IFUr3.qxd 7/25/02 4:55 pm Page 2
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`INSTRUCTIONS FOR USE FOR:
`
`en
`English
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`Edwards Lif
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`Edwards Lifesciences Corporation, et al. Exhibit 1026, p. 1 of 15
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`

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`AF1468EN1.EXCB.IFUr3.qxd 7/25/02 4:55 pm Page 3
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`TABLE OF CONTENTS
`
`DESCRIPTION ............................................................................................................Page 1
`
`INTENDED USE ..........................................................................................................Page 2
`
`CONTRAINDICATIONS................................................................................................Page 2
`
`WARNINGS ................................................................................................................Page 2
`
`PRECAUTIONS ..........................................................................................................Page 2
`
`ADVERSE EVENTS ....................................................................................................Page 3
`
`SUMMARY OF CLINICAL STUDIES............................................................................Page 4
`
`INDIVIDUALIZATION OF TREATMENT........................................................................Page 9
`
`HOW SUPPLIED ........................................................................................................Page 9
`
`STORAGE AND HANDLING ........................................................................................Page 9
`
`RECOMMENDED MATERIALS ....................................................................................Page 9
`
`DIRECTIONS FOR USE ..............................................................................................Page 9
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`Edwards Lif
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`Edwards Lifesciences Corporation, et al. Exhibit 1026, p. 2 of 15
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`AF1468EN1.EXCB.IFUr3.qxd 7/25/02 4:55 pm Page 4
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`INSTRUCTIONS FOR USE
`EXCLUDER BIFURCATED ENDOPROSTHESIS
`
`Carefully read all instructions prior to use. Observe all warnings and precautions noted
`throughout these instructions. Failure to do so may result in complications.
`DESCRIPTION
`The EXCLUDER Bifurcated Endoprosthesis (EXCLUDER Endoprosthesis) is a device that provides
`endovascular treatment of infrarenal abdominal aortic aneurysms (AAA).
`The EXCLUDER Endoprosthesis is comprised of two components, the Trunk-Ipsilateral Leg
`Endoprosthesis (Trunk) (Figure 1) and the Contralateral Leg Endoprosthesis (Figure 2). The graft
`material is expanded polytetrafluoroethylene and fluorinated ethylene propylene (ePTFE and FEP),
`and is supported by nitinol wire along its external surface. Nitinol anchors and an ePTFE/FEP sealing
`cuff are located near the aortic end of the trunk. An ePTFE/FEP sleeve is used to constrain the
`endoprostheses on the leading end of the delivery catheters (Figures 3A, 3B, and 3C).
`Deployment of both endoprosthesis components initiates from the leading (aortic) end and proceeds
`toward the trailing (iliac) end of the delivery catheter. The ePTFE/FEP sleeve remains in situ between
`the endoprosthesis and the vessel wall.
`
`Figure 1: Trunk-Ipsilateral Leg Endoprosthesis
`Radiopaque
`Anchors
`Markers (3)
`
`Ipsilateral (short) Radiopaque Marker
`
`Radiopaque
`Marker Ring
`
`Radiopaque
`Marker
`
`Sealing Cuff
`
`Contralateral (long) Radiopaque Marker
`
`Trunk-Ipsilateral Leg Endoprosthesis Radiopaque Markers
`•
`Three (3) short markers at the aortic end.
`•
`One (1) long and one (1) short marker at the endoprosthesis bifurcation level. The long
`marker denotes the contralateral leg side location and orientation.
`One (1) marker ring at the opening of the contralateral leg hole.
`One (1) short marker at the iliac end of the ipsilateral leg.
`
`•
`•
`
`Figure 2: Contralateral Leg Endoprosthesis
`
`Radiopaque
`Marker
`
`Contralateral Leg Endoprosthesis Radiopaque Markers
`•
`One (1) marker at each end
`
`Radiopaque
`Marker
`
`Figure 3A: EXCLUDER Endoprosthesis Delivery Catheter
`TRAILING END
`
`LEADING END
`
`Tuohy-Borst
`Valve
`
`Deployment
`Knob
`
`White Shaft
`Marker
`
`Flushing
`Port
`
`Guidewire
`Lumen
`
`Constrained
`Endoprosthesis
`
`1
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`Edwards Lif
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`Edwards Lifesciences Corporation, et al. Exhibit 1026, p. 3 of 15
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`AF1468EN1.EXCB.IFUr3.qxd 7/25/02 4:55 pm Page 5
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`Figure 3B: Constrained EXCLUDER Endoprosthesis (Trunk-Ipsilateral) on Delivery
`Catheter with Radiopaque Markers
`
`Ipsilateral (Short)
`Radiopaque Marker
`
`Aortic End
`Radiopaque
`Markers (3)
`
`LEADING END
`
`Radiopaque
`Contralateral (Long)
`Radiopaque Marker
`Marker Ring
`Radiopaque Marker
`on Delivery Catheter
`Figure 3C: Constrained EXCLUDER Endoprosthesis (Contralateral) on Delivery Catheter
`with Radiopaque Markers
`
`Radiopaque
`Marker
`
`LEADING END
`
`Radiopaque Marker
`on Delivery Catheter
`
`•
`•
`•
`
`Radiopaque
`Marker
`INTENDED USE
`The EXCLUDER Endoprosthesis is intended to exclude the aneurysm from the blood circulation in
`patients diagnosed with infrarenal AAA disease and who have appropriate anatomy.
`CONTRAINDICATIONS
`Known contraindications include, but are not limited to:
`•
`Significant thrombus at the arterial implantation sites, specifically proximal aortic neck and distal
`iliac artery interface
`Severe proximal aortic neck angulation > 60°
`Infrarenal aortic neck < 15 mm in length
`Ilio-femoral access vessel morphology which is not compatible with vascular access techniques,
`devices and accessories.
`WARNINGS
`• Minimize handling of the constrained endoprosthesis during preparation and insertion to
`decrease the risk of endoprosthesis contamination and infection.
`Do not advance the device outside of the sheath.
`Do not rotate the Trunk or the Contralateral Leg delivery catheter while the endoprosthesis is
`inside the introducer sheath. Catheter breakage or premature deployment may occur.
`Do not rotate the Trunk delivery catheter beyond 360° to avoid delivery system damage and/or
`premature deployment.
`Do not rotate the Contralateral Leg delivery catheter during delivery. Catheter breakage or
`premature deployment may occur.
`Do not attempt to withdraw the undeployed endoprosthesis through the 18 Fr or 12 Fr introducer
`sheath valve. The sheath and catheter must be removed together.
`Do not attempt to reposition the endoprosthesis after deployment has been initiated. Vessel
`damage or device misplacement may result.
`Do not continue advancing any portion of the delivery system if resistance is felt during
`advancement of the guidewire, sheath, or catheter. Stop and assess the cause of resistance.
`Vessel or catheter damage may occur.
`Incorrect deployment or migration of the endoprosthesis may require surgical intervention.
`Do not cover significant renal or mesenteric arteries (exceptions are inferior mesenteric and ilio-
`femoral) with the endoprosthesis. Vessel occlusion may occur.
`Do not use delivery catheter for high pressure fluid injections.
`•
`PRECAUTIONS
`•
`Do not resterilize; for single use only.
`•
`Do not use if damaged or if sterile barrier has been compromised.
`•
`Do not use after the “use by” (expiration) date printed on the label.
`
`•
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`•
`
`2
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`Edwards Lif
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`ADVERSE EVENTS
`Adverse events that may require intervention include, but are not limited to: infection; bleeding at the
`site of catheter and sheath placement; lymph fistula; local neurologic damage; ilio-femoral vascular
`access anatomy complications including vascular trauma, occlusion, arteriovenous fistula,
`thrombosis and/or pseudoaneurysm; trauma to the aortic or ilio-femoral vessel wall, including
`dissection, perforation, rupture or erosion; fever and localized inflammation; microembolization and
`macroembolization; bowel ischemia; aortoenteric fistula; acute hepatic failure; renal failure or other
`renal complications; respiratory complications; congestive heart failure; arrhythmia; myocardial
`infarction; paraplegia; stroke; incomplete device component deployment; improper endoprosthesis
`component placement; endoprosthesis component migration; stent fracture; graft material failure or
`dilatation, erosion, puncture, separation of graft material from stent; endoprosthesis occlusion;
`endoprosthesis infection; endoleak; continued aneurysm enlargement; aneurysm rupture and death.
`
`3
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`Edwards Lif
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`Edwards Lifesciences Corporation, et al. Exhibit 1026, p. 5 of 15
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`SUMMARY OF CLINICAL STUDIES
`
`OBJECTIVES
`The primary objective of the clinical study was to demonstrate that the EXCLUDER Bifurcated
`Endoprosthesis is a safe and effective alternative to open surgical repair in the primary treatment of
`infrarenal abdominal aortic aneurysms. Safety was determined by demonstrating that the EXCLUDER
`Bifurcated Endoprosthesis subjects would have a total proportion of major adverse events that is less
`than the subjects treated with open surgical repair as evaluated through one year follow-up.
`Effectiveness was based on exclusion of the aneurysm including the absence of an endoleak, the
`absence of aneurysm enlargement (≥ 5 mm), and the absence of major device efficacy adverse
`events evaluated through one year follow-up. Secondary objectives included an assessment of
`clinical benefit and quality-of-life measures.
`STUDY DESIGN
`This prospective, non-randomized, multi-center clinical study was designed to compare patients
`treated with endovascular repair to an open surgical repair control group. The control group included
`patients whose vascular anatomy (proximal aortic neck length, proximal neck angulation, and arterial
`implantation site condition) may not have been suitable for endovascular AAA repair. The planned
`ratio of EXCLUDER Bifurcated Endoprostheses to control subjects was approximately 2:1. Follow-up
`evaluations were scheduled for pre-discharge, 1-month, 3-months (if endoleak at 1-month),
`6-months and 12-months. An independent Core Lab facility reviewed CT scans and abdominal x-rays
`to assess aneurysm diameter changes, device and relative component migration, device integrity
`(wire and graft) and the presence and type of endoleaks.
`DESCRIPTION OF SUBJECTS
`Nineteen U.S. sites enrolled 235 EXCLUDER Bifurcated Endoprostheses and 99 control subjects.
`Given the epidemiology of AAA and surgical repair, males predominated over females
`(83% compared to 17%). The selection criteria for the study were based on enrolling subjects with
`the appropriate anatomy for endovascular repair. A total of 31 females were treated with EXCLUDER
`Bifurcated Endoprostheses and 26 with open surgical repair. For subjects treated with EXCLUDER
`Bifurcated Endoprostheses, there were no differences between males and females for results through
`one year for survival, freedom from major adverse events and cumulative adverse events. For open
`surgical repair subjects, females compared to males as follows: results at one year showed that
`females had a lower rate of cumulative adverse events (0.4 vs 0.8 with p=0.003), comparable
`freedom from major adverse events, and a slightly lower survival rate (87% vs 97% with p=0.07).
`
`4
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`Edwards Lif
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`RESULTS
`Tables 1 and 2 compare the subject characteristics and initial anuerysm diameter of the EXCLUDER
`Bifurcated Endoprosthesis and open surgical population, respectively.
`Table 1: Comparison of Subject Characteristics
`
`Characteristic
`
`EXCLUDER Bifurcated Endoprosthesis
`(N = 235)
`N (%)
`
`Average Age (range in years)
`
`73.0
`
`(48 - 91)
`
`Control
`(N = 99)
`N (%)
`
`70.1
`
`(51 - 87)
`
`Gender:
`Male
`Female
`
`Coronary Artery Disease
`
`Arrhythmia
`
`Valvular Heart Disease
`
`Congestive Heart Failure
`
`Stroke
`
`Aneurysm Symptomatic
`
`Inflammatory AAA
`
`Family History of AAA
`
`Other Concomitant Aneurysms
`
`Peripheral Arterial Occlusive Disease
`
`Prior Vascular Intervention
`
`Long Term Use of Steroids
`
`87%
`13%
`
`62%
`
`24%
`
`8%
`
`9%
`
`11%
`
`5%
`
`1%
`
`6%
`
`8%
`
`16%
`
`11%
`
`3%
`
`204
`31
`
`145
`
`56
`
`18
`
`22
`
`26
`
`11
`
`2
`
`14
`
`18
`
`38
`
`26
`
`8
`
`17
`
`73
`26
`
`53
`
`21
`
`7
`
`8
`
`10
`
`15
`
`1
`
`9
`
`13
`
`14
`
`10
`
`1
`
`4
`
`74%
`26%
`
`54%
`
`21%
`
`7%
`
`8%
`
`10%
`
`15%
`
`1%
`
`9%
`
`13%
`
`14%
`
`10%
`
`1%
`
`4%
`
`p-Value
`
`0.002
`
`0.004
`
`0.165
`
`0.591
`
`0.852
`
`0.708
`
`0.818
`
`<
`
`0.001
`
`1.00
`
`0.307
`
`0.116
`
`0.640
`
`0.796
`
`0.290
`
`0.332
`
`Thrombotic Event
`
`COPD
`
`Smoking History
`
`Renal Dialysis
`
`Paraplegia
`
`Erectile Dysfunction (males only)
`
`Hepatic Dysfunction
`
`Bleeding Disorder
`
`Cancer
`
`7%
`
`26%
`
`89%
`
`0%
`
`0%
`
`16%
`
`3%
`
`5%
`
`25%
`
`62
`
`208
`
`0
`
`0
`
`33
`
`6
`
`11
`
`59
`
`25
`
`84
`
`0
`
`0
`
`10
`
`1
`
`1
`
`19
`
`25%
`
`85%
`
`0%
`
`0%
`
`14%
`
`1%
`
`1%
`
`19%
`
`0.830
`
`0.357
`
`n/a
`
`n/a
`
`0.616
`
`0.679
`
`0.119
`
`0.243
`
`Table 2: Aneurysm Diameter Distribution
`
`Diameter Range
`
`EXCLUDER Bifurcated Endoprosthesis (N = 235)
`N (%)
`
`Control (N = 98)
`N (%)
`
`0
`
`0
`
`15
`
`46
`
`21
`
`10
`
`5
`
`1
`
`0%
`
`0%
`
`15.3%
`
`46.9%
`
`21.4%
`
`10.2%
`
`5.1%
`
`1.0%
`
`< 30 mm
`
`30 - 39 mm
`
`40 - 49 mm
`
`50 - 59 mm
`
`60 - 69 mm
`
`70 - 79 mm
`
`80 - 89 mm
`≥ 90 mm
`
`0
`
`0
`
`61
`
`109
`
`44
`
`15
`
`4
`
`2
`
`0%
`
`0%
`
`26%
`
`46.4%
`
`18.7%
`
`6.4%
`
`1.7%
`
`0.9%
`
`5
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`Edwards Lif
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`Edwards Lifesciences Corporation, et al. Exhibit 1026, p. 7 of 15
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`AF1468EN1.EXCB.IFUr3.qxd 7/25/02 4:55 pm Page 9
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`Data gathered in Tables 3-13 were collected by either the Core Lab or the clinical study sites.Table 3
`compares the safety and efficacy measures between the EXCLUDER Bifurcated Endoprosthesis and
`control subjects as reported by the clinical sites through the primary study end point of 12 months.
`
`The study design is based on one-year safety and effectiveness outcomes. Subject follow-up is
`continuing and two-year data are also presented.
`Table 3: Principal Safety and Efficacy Results
`
`Outcome Measures
`
`Early (≤ 30 day) Mortality
`Early (≤ 30 day) Adverse Events
`
`Early Conversion
`
`Late Conversion
`
`Rupture
`
`EXCLUDER Bifurcated Endoprosthesis
`(N = 235)
`N (%)
`
`Control
`(N=99)
`N (%)
`
`3
`
`32
`
`0
`
`0
`
`0
`
`1%
`
`14%
`
`0%
`
`0%
`
`0%
`
`0
`
`56
`
`0
`
`0
`
`0
`
`0%
`
`57%
`
`0%
`
`0%
`
`0%
`
`p-Value
`
`p = 0.56
`
`p < 0.0001
`
`n/a
`
`n/a
`
`n/a
`
`Three conversions have occurred > 24 months postoperative due to aneurysm enlargement and
`proximal neck aneurysm enlargement.
`
`Tables 4-11 describe results of the EXCLUDER Bifurcated Endoprosthesis subjects as reported by the
`Core Lab. Device performance factors analyzed by the Core Lab included device integrity (Table 4),
`device patency (Table 5), migration (Tables 6 and 7), and anuerysm exclusion (Tables 8-11). For
`device performance factors, more than one incident can occur to one subject and incidents are not
`necessarily viewed at every time point for one subject. Device integrity encompasses the structural
`findings of the wire-form via abdominal x-ray images at the corresponding follow-up timepoints.
`Table 4: Device Integrity Assessment by Abdominal X-ray Imaging Data
`
`Device Integrity: KUB
`
`Discharge
`(N = 171)
`N (%)
`
`Subjects Free from Device Integrity Issues
`Subjects with ≥ 1 Device Integrity Issue
`
`145
`
`26
`
`85%
`
`15%
`
`6 Months
`(N = 156)
`N (%)
`
`129
`
`27
`
`83%
`
`17%
`
`12 Months
`(N = 140)
`N (%)
`
`24 Months
`(N = 117)
`N (%)
`
`120
`
`20
`
`86%
`
`14%
`
`110
`
`7
`
`94%
`
`6%
`
`- Fracture
`
`- Kink
`
`- Compression
`
`1
`
`22
`
`4
`
`0.6%
`
`13%
`
`2%
`
`0
`
`18
`
`9
`
`0%
`
`12%
`
`6%
`
`0
`
`16
`
`4
`
`0%
`
`11%
`
`3%
`
`0
`
`4
`
`3
`
`0%
`
`3%
`
`3%
`
`Table 5: Occlusion or Narrowing of the Flow Channel by CT Imaging Data
`
`Occlusion / Narrowing
`
`1 Month
`(N = 212)
`N (%)
`
`6 Months
`(N = 193)
`N (%)
`
`12 Months
`(N = 185)
`N (%)
`
`24 Months
`(N = 148)
`N (%)
`
`EXCLUDER Bifurcated Endoprosthesis
`3
`1.5%
`Table 6: CT Findings – Trunk Migration
`
`0
`
`0%
`
`2
`
`1.1%
`
`2
`
`1.4%
`
`CT - Trunk Migration
`
`6 Months
`(N = 171)
`N (%)
`
`12 Months
`(N = 175)
`N (%)
`
`Trunk Migration
`2.3%
`5
`3.0%
`4
`Table 7: Abdominal X-ray Findings – Component Migration
`
`Abdominal X-ray -
`Component Migration
`
`Component Migration
`
`6 Months
`(N = 139)
`N (%)
`
`2
`
`1.4%
`
`12 Months
`(N = 139)
`N (%)
`
`1
`
`1.0%
`
`24 Months
`(N = 144)
`N (%)
`
`2
`
`1.4%
`
`24 Months
`(N = 122)
`N (%)
`
`1
`
`1.0%
`
`6
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`Edwards Lif
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`Edwards Lifesciences Corporation, et al. Exhibit 1026, p. 8 of 15
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`AF1468EN1.EXCB.IFUr3.qxd 7/25/02 4:55 pm Page 10
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`Table 8: Endoleak Status According to Evaluation Interval
`
`Evaluation Interval
`
`Type of Endoleak1,2
`
`1 Month
`(N = 180)
`N (%)
`
`6 Months
`(N = 177)
`N (%)
`
`12 Months
`(N = 156)
`N (%)
`
`24 Months
`(N = 119)
`N (%)
`
`Type I
`
`Type II
`
`Type III
`
`Type IV
`
`Indeterminate
`
`Total
`
`7
`
`21
`
`0
`
`0
`
`11
`
`39
`
`4%
`
`12%
`
`0%
`
`0%
`
`6%
`
`22%
`
`3
`
`19
`
`0
`
`0
`
`14
`
`36
`
`2%
`
`11%
`
`0%
`
`0%
`
`7%
`
`20%
`
`2
`
`19
`
`0
`
`0
`
`6
`
`27
`
`1%
`
`12%
`
`0%
`
`0%
`
`4%
`
`17%
`
`3
`
`16
`
`0
`
`0
`
`5
`
`24
`
`3%
`
`13%
`
`0%
`
`0%
`
`4%
`
`20%
`
`Table 9: Change in Aneurysm Size by Interval
`
`Change in Aneurysm Size
`
`1 Month to 6 Months
`(N = 182)
`N (%)
`
`1 Month to 12 Months
`(N = 181)
`N (%)
`
`1 Month to 24 Months
`(N = 146)
`N (%)
`
`Decrease
`
`10%
`
`14%
`
`28
`
`No Change
`
`Increase
`
`18
`
`159
`
`5
`
`87%
`
`3%
`
`26
`
`142
`
`13
`
`78%
`
`7%
`
`97
`
`21
`
`19%
`
`67%
`
`14%
`
`Table 10: Maximum Aneurysm Diameter and Endoleaks at 12 Months
`
`Aneurysm Change from 1 to 12 Months*
`
`Increase (≥ 5 mm)
`
`No Change
`Decrease (≤ 5 mm)
`
`N
`
`10
`
`118
`
`18
`
`Endoleak at 12 Months*
`N (%)
`
`p-Value
`
`4
`
`19
`
`2
`
`40%
`
`16%
`
`11%
`
`Total
`146
`25
`17%
`0.12
`* Only includes subjects with interpretable films (endoleak) and measurements of aneurysm
`change from 1 to 12 months.
`Table 11: Maximum Aneurysm Diameter and Endoleaks at 24 Months
`
`Aneurysm Change from 1 to 24 Months*
`
`Increase (≥ 5 mm)
`
`No Change
`Decrease (≤ 5 mm)
`
`N
`
`15
`
`74
`
`23
`
`Endoleak at 24 Months*
`N (%)
`
`p-Value
`
`7
`
`10
`
`2
`
`47%
`
`14%
`
`9%
`
`Total
`112
`19
`17%
`0.004
`* Only includes subjects with interpretable films (endoleak) and measurements of aneurysm
`change from 1 month to 24 months.
`
`Secondary interventions within the first and second year each were performed in 6% of the
`EXCLUDER Bifurcated Endoprostheses subjects as shown in Table 12. All interventions were
`catheter-based. Subjects may have a single intervention for an endoleak and an aneurysm
`enlargement.
`Table 12: Interventions for Endoleak and Aneurysm Size Increases
`
`Intervention
`
`Number of Subjects with ≥ 1 Intervention
`
`Treat an Endoleak:
`Embolization
`Ligation
`Conversion to open repair
`
`Treat an Aneurysm Increase:
`Embolization
`Ligation
`Conversion to open repair
`
`Post-procedure to 12 Months
`(N = 235)
`N (%)
`
`> 12 Months to 24 Months
`(N = 203)
`N (%)
`
`12
`
`8
`0
`2*
`
`5
`0
`3*
`
`6%
`
`4%
`0%
`1%
`
`3%
`0%
`1%
`
`6%
`
`7%
`0%
`0%
`
`0%
`0%
`0%
`
`15
`
`16
`1
`0
`
`0
`1
`0
`
`7
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`As described in Table 13, treatment of AAA with EXCLUDER Bifurcated Endoprosthesis compared to
`the control group demonstrated significant benefits in recovery and quality of life measures.
`Table 13: Secondary Outcomes by Treatment Group
`
`Control
`
`1590
`(100 - 7000)
`
`89%
`
`196
`(67 - 420)
`
`87%
`
`9.8
`(3 - 114)
`
`2.6
`(0.07 - 9.5)
`
`2.6
`(0 - 18)
`
`p-Value
`
`< 0.0001
`
`< 0.0001
`
`< 0.0001
`
`< 0.0001
`
`< 0.0001
`
`< 0.0001
`
`< 0.0001
`
`Secondary Outcomes
`
`EXCLUDER Bifurcated
`Endoprosthesis
`
`310
`(50 - 2160)
`
`14%
`
`144
`(51 - 320)
`
`24%
`
`2 0
`
`(1 - 11)
`
`.5
`(0 - 2.1)
`
`1.0
`(0 - 5.0)
`
`Blood Loss (ml)
`Mean (range)
`
`Procedure Transfusion (%)
`
`Procedure Time (minutes)
`Mean (range)
`
`ICU Stay (%)
`
`Hospital Length of Stay (days)
`Mean (range)
`
`Time to First Oral Intake (days)
`Mean (range)
`
`Time to Ambulation (days)
`Mean (range)
`
`CONCLUSIONS FROM CLINICAL STUDIES
`As compared to conventional open surgery, the clinical benefits of the EXCLUDER Bifurcated
`Endoprosthesis are a lower rate of major complications, reduced blood loss and blood replacement
`volume, reduced need for an ICU stay, shorter hospitalization and faster return to normal activities.
`The risks include procedure- and/or device-related phenomenon, which include but are not limited to
`endoleaks and increase in aneurysm size.
`
`1 White GH, May J, Waugh RC, et al. Type II and type IV endoleak: Toward a complete definition of
`blood flow in the sac after endoluminal AAA repair. J Endovasc Surg 5:305-309, 1998.
`2 White GH, Yu W, May J, et al. Endoleak as a complication of endoluminal grafting of abdominal
`aortic aneurysms: Classification, incidence, diagnosis and management. J Endovasc Surg
`4:152-168, 1997.
`
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`INDIVIDUALIZATION OF TREATMENT
`These endoprostheses have not been studied in the following patient populations: traumatic,
`ruptured, or mycotic aneurysms; pseudoaneurysms resulting from previous graft or stent-graft
`placement; pregnant females; genetic connective tissue disease (e.g., Marfans or Ehlers-Danlos
`Syndromes); concomitant thoracic aortic or thoracoabdominal aneurysms.
`HOW SUPPLIED
`The EXCLUDER Endoprosthesis is preloaded on a delivery catheter and supplied sterile and
`non-pyrogenic.
`STORAGE AND HANDLING
`Store in a cool dry place.
`RECOMMENDED MATERIALS
`•
`0.035” (0.89 mm) ‘super-stiff’ guidewire, 145 cm or longer
`•
`18 Fr x 30 cm and 12 Fr x 30 cm introducer sheaths (Tables 13 and 14)
`•
`Large diameter, low pressure aortic balloon (Monitor balloon volumes and pressures as
`recommended in balloon catheter Instructions for Use)
`Percutaneous transluminal angioplasty (PTA) balloons (Table 14)
`•
`Angiographic radiopaque marker catheter
`•
`Contrast media
`•
`Syringe
`•
`Heparin and heparinized saline
`•
`Table 14: Trunk-Ipsilateral Leg Endoprosthesis Sizing Guide*
`
`Intended Aortic
`Vessel Diameter
`(mm)
`19 - 21
`
`Aortic Endoprosthesis
`Diameter1
`(mm)
`23
`
`Intended
`Iliac Vessel
`Diameter (mm)
`10 - 11
`
`Iliac
`Endoprosthesis
`Diameter2 (mm)
`12
`
`Overall Device
`Lengths
`(cm)
`14, 16, 18
`
`Recommended
`Introducer Sheath
`(Fr x cm)
`18 x 30
`
`22 - 23
`
`24 - 26.5
`
`26
`
`28.5
`
`12 - 13.5
`10 - 11
`
`12 - 13.5
`10 - 11
`
`12 - 13.5
`
`14.5
`12
`
`14.5
`12
`
`14.5
`
`14, 16, 18
`
`18 x 30
`
`14, 16, 18
`
`18 x 30
`
`1 Recommended endoprosthesis oversizing relative to the aortic vessel is approximately 10-21% and
`7-25% for the iliac vessel.
`2 Recommended angioplasty balloon size is 12 mm and 14 mm respectively
`* Note: All dimensions are nominal
`Table 15: Contralateral Leg Endoprosthesis Sizing Guide*
`
`Intended Iliac
`Vessel Diameter
`(mm)
`10 - 11
`12 -13.5
`
`Iliac Endoprosthesis
` Diameter1
`(mm)
`12
`14.5
`
`Overall Device
`Lengths
`(cm)
`10, 14, 16
`10, 14, 16
`
`Recommended Contralateral
`Introducer Sheath
`(Fr x cm)
`12 x 30
`12 x 30
`
`Recommended Angioplasty
`Balloon Size
`(mm)
`12 x 40
`14 x 40
`
`1 Recommended endoprosthesis oversizing relative to the vessel is approximately 7-25%
`* Note: All dimensions are nominal
`
`DIRECTIONS FOR USE
`
`•
`
`•
`
`•
`
`Pre-Treatment Planning
`•
`Determine accurate size of anatomy and proper size of Trunk-Ipsilateral and Contralateral
`Endoprosthesis (Tables 14 and 15).
`Use high resolution, non-contrast and contrast enhanced computerized tomography (CT) at
`≤ 3 mm acquisition and reconstruction collimation.
`Use multiple view, digital subtraction angiography with a radiopaque marker catheter or spiral
`CT multi-planar reconstruction.
`For angiography, use correct imaging angulation (cranial-caudal, lateral-oblique) to accurately
`identify origin of branch vessel anatomy.
`Consider breath-hold technique to optimize digital subtraction angiography image quality.
`
`•
`
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`2.
`
`3.
`
`4.
`
`4.
`
`5.
`
`•
`•
`•
`•
`
`Anatomical Requirements
`For Trunk-Ipsilateral Leg Endoprosthesis: Proximal aortic neck angulation ≤ 60° with minimal
`•
`thrombus and/or calcification.
`Proximal aortic neck length ≥ 15mm.
`Non-aneurysmal iliac artery length ≥ 10 mm
`For Contralateral Leg Endoprosthesis: Non-aneurysmal iliac artery length ≥ 10 mm
`Ilio-femoral access vessel morphology should be compatible with vascular access techniques,
`devices and accessories.
`Arterial Access and Angiography
`1.
`Following standard practices, access the intended contralateral side via a percutaneous
`diagnostic sheath, and perform marker catheter digital subtraction angiography (AP, oblique and
`lateral views as necessary) to confirm the correct device component sizing, and deployment
`locations. Consider breath-hold technique to optimize image quality. Leave marker catheter in
`place at the level of the renal arteries.
`Following standard practices, perform percutaneous access and/or surgical exposure of the
`vessels selected to receive the Trunk-Ipsilateral and Contralateral side introducer sheaths.
`Following the manufacturer’s instructions for use, advance an 0.035” (0.89 mm) ‘super-stiff’
`guidewire, or acceptable equivalent to the level of the renal arteries.
`Following the manufacturer’s instructions for use, prepare and advance the 18 Fr diameter x 30 cm
`length, introducer sheath/dilator over the guidewire, through the ilio-femoral anatomy, aortic
`aneurysm and up to the level of the proximal aortic neck according to standard practice.
`5. Administer heparin according to standard practice.
`6. Use standard heparinized saline, pressure flush system technique to prevent thrombus formation
`in the introducer sheaths.
`7. Use an accurate radiopaque patient marking method to assure accurate device positioning and
`deployment locations.
`Catheter Preparation
`1. Use new, sterile gloves and minimize handling the endoprosthesis portion of the delivery
`catheters.
`2. Remove the appropriately sized Trunk-Ipsilateral and Contralateral Leg delivery catheters from
`their packaging and examine for possible damage.
`3. Remove protective packaging mandrel and packaging sheath(s) from the leading end of the
`delivery catheters (Figure 3A).
`Flush with heparinized saline through the flushing port on the trailing end of the delivery catheter
`(Figure 3A).
`Follow the manufacturer’s recommended method for size selection, preparation and use of aortic
`and iliac dilation balloons. Carefully inflate the balloon to avoid complications.
`Trunk-Ipsilateral Leg Endoprosthesis Positioning and Deployment
`1. Use fluoroscopic visualization for all guidewire, sheath and device catheter manipulations.
`2. Advance the Trunk delivery catheter over a 0.035” (0.89 mm) ‘super-stiff’ guidewire, through the
`18 Fr x 30 cm long introducer sheath into the aorta to the approximate level of intended
`positioning. Warning: The catheter should not be rotated while the endoprosthesis is within
`the introducer sheath to avoid premature deployment.
`3. While maintaining the delivery catheter in position, withdraw the introducer sheath back to the
`white shaft marker on the delivery catheter (Figure 3A).
`4. Magnify and center the fluoroscopic image on the proximal trunk. Reposition and rotate the
`Trunk-Ipsilateral delivery catheter as necessary to properly position the proximal device marker
`as well as orient the long contralateral, and short ipsilateral radiopaque markers and device
`position on the appropriate side of the anatomy. Maximize the separation between these two
`markers to achieve maximum lateral positioning of the iliac legs of the device. The long marker
`should be oriented toward the contralateral side (Figure 1).
`It is recommended to view and confirm the distal position of the iliac end of the device relative
`to the internal iliac artery to ensure accurate and desired deployment position of the distal
`aspect of device.
`If clinically acceptable, lower the patient’s blood pressure to 60-70 mm Hg during Trunk
`deployment and aortic balloon inflation to decrease blood flow and reduce the risk of
`endoprosthesis movement.
`7. Maintain a contralateral access side sheath, catheter or guidewire in position across the distal,
`native bifurcation to protect and ensure that contralateral access is maintained into the
`aneurysm sac and contralateral leg hole of the device during Trunk-Ipsilateral component
`deployment.
`
`5.
`
`6.
`
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`4.
`
`8. Re-center and magnify the image on the proximal Trunk of the device to assure final desired
`position of proximal device relative to anatomy. Stabilize the Trunk delivery catheter at the level
`of entry into the introducer sheath and stabilize the sheath relative to the patient’s access site.
`9. Loosen the deployment knob. Confirm final device position and orientation and deploy the Trunk
`using a steady and continuous pull of the deployment knob to release the endoprosthesis. Pull
`the deployment knob straight out from the catheter side arm. Deployment initiates from the
`leading end toward the trailing end. Warning: Once deployment is initiated, do not attempt to
`reposition the endoprosthesis.
`10. Use fluoroscopic guidance during the withdrawal of the delivery catheter to assure safe removal
`from, and to avoid catching on, the endoprosthesis.
`11. Position the aortic balloon inside the proximal region of the trunk. Avoid balloon contact with the
`flow splitter which is aligned with the long and short radiopaque markers. Inflate and deflate the
`balloon quickly with dilute contrast solution to seat the aortic end of the endoprosthesis. Follow
`the manufacturer’s recommended method for size selection, preparation and use of aortic and
`iliac dilation balloons, carefully monitoring both volume and pressure to avoid complications.
`12. Use fluoroscopic guidance to ensure the balloon is completely deflated and is safely removed
`from the endoprosthesis.
`13. Advance and inflate the appropriate size PTA balloon catheter to seat the iliac end of the
`endoprosthesis. Follow the manufacturer’s recommended method for size selection, preparation
`and use of PTA balloons. Carefully inflate the balloon to avoid complication.
`Contralateral Endoprosthesis Positioning and Deployment
`1. Use fluoroscopic visualization for all guidewire, sheath and device catheter manipulations.
`2.
`Following manufacturer’s instructions for use, advance a 0.035” (0.89 mm) ‘superstiff’ guidewire
`into the contralateral leg hole of the Trunk according to standard practice.
`3. Verify that the guidewire is within the contralateral leg hole of the Trunk by rotating a formed
`pigtail catheter within the Trunk, or by standard practice used to verify guidewire location.
`Following manufacturer’s instructions for use, introduce the 12 Fr x 30 cm long contralateral
`introducer sheath and dilator. Advance the sheath over the guidewire and through the
`contralateral leg hole of the Trunk.
`5. Advance the prepped Contralateral Endoprosthesis delivery catheter to the level of the long
`radiopaque marker (Figure 1). Warning: Do not attempt to rotate the Contralateral Leg
`Endoprosthesis catheter at any point to avoid catheter breakage or premature deployment.
`6. Align the radiopaque marker at the proximal end of the Contralateral Leg Endoprosthesis with
`the long contralateral radiopaque marker on the Trunk-Ipsilateral Leg Endoprosthesis.
`7. While maintaining the delivery catheter in position, withdraw the introducer sheath back to the
`white shaft marker on the delivery catheter (Figure 3A).
`8. Stabilize the Contralateral Leg Endoprosthesis delivery catheter at the level of entry into the
`introducer sheath and stabilize the sheath relative to the patient’s access site.
`9. Loosen the deployment knob. Confirm final device position. Deploy the Contralateral Leg
`Endoprosthesis by using a steady, continuous pull of the deployment knob to release the
`endoprosthesis. Pull the deployment knob straight out from the catheter side-arm. Deployment
`initiates from the leading (aortic) end toward the trailing (iliac) end. Warning: Once deployment
`is initiated, do not attempt to reposition the endoprosthesis.
`10. Use fluoroscopic guidance during withdrawal of the delivery catheter to assure safe removal
`from the endoprosthesis.
`11. Following manufacturer’s instructions for use, advance and inflate a 14 mm PTA balloon catheter
`to seat the proximal end of the Contralateral Leg Endoprosthesis within the contralateral leg hole
`overlap region. Follow the manufacturer’s recommended method for size selection, preparation
`and use of aortic and iliac dilation balloons, carefully monitoring both volume and pressure to
`avoid complications.
`12. Following manufacturer’s instructions for use, advance and inflate the appropriate size PTA
`balloon to seat the iliac end of the Contralateral Leg Endoprosthesis. Follow the manufacturer’s
`recommended method for size selection, preparation and use of PTA balloons. Carefully inflate
`the balloon to avoid complications.
`
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`Completion of the Procedure
`1. Perform extended imaging angiography to confirm exclusio