Four-Year Results of the Four-Year Results of the Pivotal U.S. Multicenter Trial Pivotal U.S. Multicenter Trial of the Endologix Powerlink of the Endologix Powerlink

Endograft for EVAREndograft for EVAR

Rodney White, MDRodney White, MD

Harbor UCLA Medical CenterHarbor UCLA Medical Center

Torrance, CATorrance, CA

Conflicts of Interest Conflicts of Interest &&

Off-Label Use DisclosureOff-Label Use Disclosure

Investigational trial support from multiple Investigational trial support from multiple manufacturersmanufacturers

Paid consultant and advisory boards forPaid consultant and advisory boards forMedtronic, Boston-Scientific, WL Gore, Medtronic, Boston-Scientific, WL Gore,

Endologix, General Electric – OEC, and Endologix, General Electric – OEC, and VolcanoVolcano

PowerlinkPowerlink®® System: System:

Unibody-Bifurcated Design Unibody-Bifurcated Design Long Main BodyLong Main Body Low-Porosity Proprietary Low-Porosity Proprietary

ePTFE FormulationePTFE Formulation Cobalt Chromium Alloy Cobalt Chromium Alloy

StentStent Single-wire Main Body Single-wire Main Body

ConstructionConstruction Fully SupportedFully Supported

PowerlinkPowerlink®® U.S. Pivotal Trial U.S. Pivotal Trial 192 patients enrolled between July 2000 and March 2003192 patients enrolled between July 2000 and March 2003

Eligibility CriteriaEligibility Criteria Proximal Infrarenal Neck:Proximal Infrarenal Neck:

>>15mm length15mm length <60<60° angle° angle 26mm maximum diameter, 18mm minimum diameter26mm maximum diameter, 18mm minimum diameter

AAA AAA >>4.0 cm diameter or rapidly growing AAA4.0 cm diameter or rapidly growing AAA Iliac diameter Iliac diameter >>7mm on at least one side (for access)7mm on at least one side (for access) Dispensable inferior mesenteric arteryDispensable inferior mesenteric artery Preservation of at least one hypogastric arteryPreservation of at least one hypogastric artery Iliac seal zone of Iliac seal zone of >>15mm length (15mm length (<<18mm diameter)18mm diameter) Aortic bifurcation diameter Aortic bifurcation diameter >>18mm18mm >>18 years old18 years old Not pregnantNot pregnant Candidate for open AAA repairCandidate for open AAA repair Serum creatinine Serum creatinine <<1.7mg/dlL1.7mg/dlL Willingness to comply with follow-up scheduleWillingness to comply with follow-up schedule No bleeding disordersNo bleeding disorders Life expectancy >2 yearsLife expectancy >2 years No connective tissue disordersNo connective tissue disorders

Summary of Significant Early Clinical FindingsSummary of Significant Early Clinical FindingsPowerlinkPowerlink ControlControl P-valueP-value

AgeAge 73.2 73.2 ++ 7.0 7.0 69.7 69.7 ++ 7.9 7.9 <0.0008<0.0008

Successful DeploymentSuccessful Deployment 188/192 – 97.9%188/192 – 97.9% N/AN/A N/AN/A Patients with at least 1 Patients with at least 1 MajorMajor†† AE (0-30days) AE (0-30days) 13/192 - 6.8%13/192 - 6.8% 14/66 - 21.2%14/66 - 21.2% <0.0020<0.0020

All Death All Death << 30 days 30 days 2*/192 - 1.0%2*/192 - 1.0% 4/66 - 6.1%4/66 - 6.1% < 0.0389< 0.0389 Anesthesia Time (min)Anesthesia Time (min) 185.1 185.1 ++ 82.2 82.2 293.8 293.8 ++ 111.5 111.5 <0.0001<0.0001 Procedure Time (min)Procedure Time (min) 135.9 135.9 ++ 65.9 65.9 222.3 222.3 ++ 100.1 100.1 <0.0001<0.0001

Blood Loss (l)Blood Loss (l) 0.34 0.34 ++ 0.41 0.41 1.58 1.58 ++ 1.6 1.6 <0.0001<0.0001

Days in ICUDays in ICU 0.78 0.78 ++ 1.5 1.5 4.1 4.1 ++ 8.4 8.4 <0.0001<0.0001 Days to DischargeDays to Discharge 3.3 3.3 ++ 3.4 3.4 9.5 9.5 ++ 7.7 7.7 <0.0001<0.0001

† † Defined as death, MI, stroke, AAA rupture, conversion, secondary procedure, Defined as death, MI, stroke, AAA rupture, conversion, secondary procedure, coronary intervention, renal failure, or respiratory failurecoronary intervention, renal failure, or respiratory failure

* Not device related

Carpenter JP, et al. Midterm results of the multicenter trial of the Powerlink bifurcated system for endovascular aortic aneurysm repair. J Vasc Surg 2004;40:849-59.

Secondary Procedures Secondary Procedures through 60 months*through 60 months*

34 procedures in 26 patients34 procedures in 26 patientsEndoleak –23 (Cuffs, embolization, balloon Endoleak –23 (Cuffs, embolization, balloon

dilatation)dilatation)Type II Endoleak – 17 Type II Endoleak – 17 Type I Endoleak – 6Type I Endoleak – 6

Graft Limb Occlusion – 7 Graft Limb Occlusion – 7 Embolectomy,Stent, PTA, or Lytic TherapyEmbolectomy,Stent, PTA, or Lytic Therapy

Native Artery Procedures – 3Native Artery Procedures – 3Aortic Neck Dilation - 1Aortic Neck Dilation - 1

* As of December 16, 2005

Conversion, Rupture, MigrationConversion, Rupture, Migrationthrough 60 months*through 60 months*

Surgical conversions – 4 Surgical conversions – 4 Intraoperative – 3Intraoperative – 3@12 mo. – 1@12 mo. – 1

Aneursym rupture – 0 Aneursym rupture – 0

5 Migrations (> 10mm)5 Migrations (> 10mm)All caudal All caudal None leading to secondary procedureNone leading to secondary procedure

*As of December 16, 2005

Core Lab AnalysisCore Lab AnalysisEndoleaks (All Types, New and Persistent)Endoleaks (All Types, New and Persistent)††

1 mo1 mo

(N=123)(N=123)

6 mo6 mo

(N=119)(N=119)

12 mo12 mo

(N=147)(N=147)

24 mo24 mo

(N=123)(N=123)

36 mo36 mo

(N=109)(N=109)

48 mo48 mo

(N=64)(N=64)

60 mo60 mo

(N=16)(N=16)

All EndoleaksAll Endoleaks 2525 1313 1818 99 77 44 11

Type IType I 11 00 00 00 11 00 00

Type IIType II 2020 1313 1515 77 55 33 00

Type IIIType III 00 00 00 00 00 00 00

Type IVType IV 00 00 00 00 00 00 00

MultipleMultiple 22 00 11 00 00 00 00

IIndeterminatendeterminate 22 00 22 22 11 11 11

††As of December 16, 2005

Sac Diameter Over TimeSac Diameter Over Time††

† As of December 16m 2005

* 192 patients enrolled, 3 patients’ CT’s lost before submission to core lab

Diameter (mm)Diameter (mm) Pre-opPre-op

(N=189)(N=189)**

12 mo12 mo

(N=147)(N=147)

24 mo24 mo

(N=123)(N=123)

36 mo36 mo

(N=109)(N=109)

48 mo48 mo

(N=64)(N=64)

60 mo60 mo

(N=16)(N=16)

Mean Mean

(SD)(SD)

50.450.4

(7.0)(7.0)

45.845.8

(7.9)(7.9)

42.942.9

(8.7)(8.7)

41.441.4

(9.2)(9.2)

39.539.5

(8.9)(8.9)

35.235.2

(5.5)(5.5)

MinimumMinimum 37.337.3 30.230.2 27.827.8 26.826.8 27.127.1 27.327.3

MaximumMaximum 74.374.3 72.472.4 69.769.7 72.172.1 65.465.4 48.848.8

Sac Volume Over TimeSac Volume Over Time††

† As of December 16, 2005

* 192 patients enrolled, 3 patients’ CT’s lost before submission to core lab

** Some CT scans are not evaluable for some parameters most often due to poor image quality, no contrast, CT’s taken at greater than 3mm slices, etc.

Volume (cc)Volume (cc) Pre-opPre-op

(N=187)*(N=187)*

12 mo12 mo

(N=144)(N=144)

24 mo24 mo

(N=121)(N=121)

36 mo36 mo

(N=109)(N=109)

48 mo48 mo

(N=64)(N=64)

60 mo60 mo

(N=15)(N=15)

Mean Mean

(SD)(SD)

135.4135.4

(39.4)(39.4)

124.6124.6

(40.3)(40.3)

118.9118.9

(38.4)(38.4)

115.4115.4

(37.8)(37.8)

110.8110.8

(30.7)(30.7)

102.7102.7

(20.3)(20.3)

MinimumMinimum 70.870.8 62.862.8 58.358.3 54.154.1 65.265.2 70.870.8

MaximumMaximum 270.5270.5 292.4292.4 293.9293.9 279.2279.2 204.9204.9 141.5141.5

Unevaluable**Unevaluable** 22 33 22 00 00 11

Morphology Change Sub-Analysis Morphology Change Sub-Analysis Method:Method:

Patients with paired data (both a 1-month and Patients with paired data (both a 1-month and either a 2-year, 3-year, 4-year, or 5-year follow-either a 2-year, 3-year, 4-year, or 5-year follow-up CT) as of December 16, 2005 were included up CT) as of December 16, 2005 were included in this analysisin this analysis

Current Analysis N = 78 pts. Current Analysis N = 78 pts. All CT’s were analyzed by study core lab utilizing All CT’s were analyzed by study core lab utilizing

proprietary 3-D reconstruction software (proprietary 3-D reconstruction software (Medical Medical Metrx Solutions, West Lebanon, NHMetrx Solutions, West Lebanon, NH))

Analysis:Analysis:

Mean max. sac diameterMean max. sac diameter Mean sac volumeMean sac volume Distance between distal renal and aortic bifurcationDistance between distal renal and aortic bifurcation ΔΔ in maximum sac angulation in maximum sac angulation

Sac angle calculation was determined from distal Sac angle calculation was determined from distal proximal neck to maximum inflection point in the sac proximal neck to maximum inflection point in the sac to aortic bifurcation (180° = straight line through to aortic bifurcation (180° = straight line through sac)sac)

Overall Results:Overall Results:

1- Mo.1- Mo. 2-Yr.2-Yr. 3-Yr.3-Yr. 4-Yr.4-Yr. 5-Yr.5-Yr.

Mean Max. Sac Mean Max. Sac AngleAngle

144.1144.1°° 151.6 °151.6 ° 153.6153.6°° 154.7 °154.7 ° 158.4°158.4°

Mean Max. Sac Mean Max. Sac DiameterDiameter

50.5 mm50.5 mm 43.0 mm43.0 mm 41.8 mm41.8 mm 39.5 mm39.5 mm 35.2 mm35.2 mm

Mean Aortic Mean Aortic VolumeVolume

137.0 ml137.0 ml 118.9 ml118.9 ml 117.2ml117.2ml 110.8 ml110.8 ml 102.7 ml102.7 ml

Mean Distance Mean Distance Between Distal Between Distal Renal & BifurcationRenal & Bifurcation

118.5 mm118.5 mm 121.6 mm121.6 mm 122.0 mm122.0 mm 124.4 mm124.4 mm 122.8 mm122.8 mm

Paired Results:Paired Results:1-Mo. - 2-Yr.1-Mo. - 2-Yr.

(n=70)(n=70)

1-Mo. - 3-Yr.1-Mo. - 3-Yr.

(n=67)(n=67)

1-Mo. - 4-Yr.1-Mo. - 4-Yr.

(n=39)(n=39)

1-Mo. - 5-Yr.1-Mo. - 5-Yr.

(n=6)(n=6)

% w/ Max. Sac Angle % w/ Max. Sac Angle Becoming StraighterBecoming Straighter

78.6% 78.6% 82.1%82.1% 69.2 %69.2 % 83.3 %83.3 %

Δ in Mean Max. Sac Angle Δ in Mean Max. Sac Angle Becoming StraighterBecoming Straighter

10.910.9°° 11.8 11.8 °° 12.6 12.6 °° 12.7 12.7 °°

% w/ Max. Sac Angle % w/ Max. Sac Angle Same or Becoming More Same or Becoming More AngledAngled

21.4%21.4% 17.9%17.9% 30.8 %30.8 % 16.7 %16.7 %

Δ in Mean Max. Sac Angle Δ in Mean Max. Sac Angle Same or Becoming More Same or Becoming More AngledAngled

-3.6 °-3.6 ° -6.9 °-6.9 ° -8.8 °-8.8 ° -18 °-18 °

Δ in Mean Length from Δ in Mean Length from Distal Renal to BifurcationDistal Renal to Bifurcation

2.3 mm2.3 mm 2.0 mm2.0 mm 1.9 mm1.9 mm 3.2 mm3.2 mm

Example: Pt. w/ 22.6Example: Pt. w/ 22.6° Straighter Sac Angle° Straighter Sac Angle

1 – Mth. 3 – Yr.

Distal End of Bifurcated Region

4-29-05 5-13-05

Summary of Late Clinical FindingsSummary of Late Clinical Findings

97.9 % Freedom from AAA-Related 97.9 % Freedom from AAA-Related Mortality at 4 years with the Powerlink Mortality at 4 years with the Powerlink SystemSystem

No aneurysm rupturesNo aneurysm rupturesOnly 1 late conversion (@ 1 yr.)Only 1 late conversion (@ 1 yr.)No ePTFE graft material failures at 4 yearsNo ePTFE graft material failures at 4 yearsNo cobalt chromium stent graft failure or No cobalt chromium stent graft failure or

fatigue at 4 yearsfatigue at 4 years

Conclusions:Conclusions: Powerlink System appears safe and effective in Powerlink System appears safe and effective in

protecting patients from AAA ruptureprotecting patients from AAA rupture All cohorts treated w/ PowerlinkAll cohorts treated w/ Powerlink®® experienced: experienced:

Aneurysm sac diameter & volume reductionAneurysm sac diameter & volume reduction Remodeling or shrinking of aneurysm sac around device Remodeling or shrinking of aneurysm sac around device

as evidenced by straightening of the aortaas evidenced by straightening of the aorta Minimal change in length of aorta from distal renal to Minimal change in length of aorta from distal renal to

bifurcation regardless of sac angle changebifurcation regardless of sac angle change Sac remodeling does not appear to contribute to

graft migration with the Powerlink stent graft The column strength and long main body of the The column strength and long main body of the

PowerlinkPowerlink®® may directly influence the classical may directly influence the classical remodeling of the aneurismal aortaremodeling of the aneurismal aorta