Four-Year Results of the Pivotal U.S. Multicenter Trial of the Endologix Powerlink Endograft for EVAR Rodney White, MD Harbor UCLA Medical Center Torrance, CA

Conflicts of Interest & Off-Label Use Disclosure Investigational trial support from multiple manufacturers Investigational trial support from multiple manufacturers Paid consultant and advisory boards for Paid consultant and advisory boards for Medtronic, Boston-Scientific, WL Gore, Medtronic, Boston-Scientific, WL Gore, Endologix, General Electric – OEC, and Volcano Endologix, General Electric – OEC, and Volcano

Powerlink ® System: Unibody-Bifurcated Design Unibody-Bifurcated Design Long Main Body Long Main Body Low-Porosity Proprietary ePTFE Formulation Low-Porosity Proprietary ePTFE Formulation Cobalt Chromium Alloy Stent Cobalt Chromium Alloy Stent Single-wire Main Body Construction Single-wire Main Body Construction Fully Supported Fully Supported

Powerlink ® U.S. Pivotal Trial 192 patients enrolled between July 2000 and March patients enrolled between July 2000 and March 2003 Eligibility Criteria Eligibility Criteria Proximal Infrarenal Neck: Proximal Infrarenal Neck: >15mm length >15mm length <60° angle <60° angle 26mm maximum diameter, 18mm minimum diameter 26mm maximum diameter, 18mm minimum diameter AAA >4.0 cm diameter or rapidly growing AAA AAA >4.0 cm diameter or rapidly growing AAA Iliac diameter >7mm on at least one side (for access) Iliac diameter >7mm on at least one side (for access) Dispensable inferior mesenteric artery Dispensable inferior mesenteric artery Preservation of at least one hypogastric artery Preservation of at least one hypogastric artery Iliac seal zone of >15mm length ( 15mm length (<18mm diameter) Aortic bifurcation diameter >18mm Aortic bifurcation diameter >18mm >18 years old >18 years old Not pregnant Not pregnant Candidate for open AAA repair Candidate for open AAA repair Serum creatinine <1.7mg/dlL Serum creatinine <1.7mg/dlL Willingness to comply with follow-up schedule Willingness to comply with follow-up schedule No bleeding disorders No bleeding disorders Life expectancy >2 years Life expectancy >2 years No connective tissue disorders No connective tissue disorders

Summary of Significant Early Clinical Findings PowerlinkControlP-value Age Age < Successful Deployment Successful Deployment 188/192 – 97.9% N/A N/AN/A Patients with at least 1 Major AE (0-30days) Patients with at least 1 Major AE (0-30days) 13/ % 14/ % 14/ %< All Death < 30 days All Death < 30 days 2*/ % 4/ % 4/ % < Anesthesia Time (min) Anesthesia Time (min) < Procedure Time (min) Procedure Time (min) < Blood Loss (l) Blood Loss (l) < Days in ICU Days in ICU < Days to Discharge Days to Discharge < Defined as death, MI, stroke, AAA rupture, conversion, secondary procedure, coronary intervention, renal failure, or respiratory failure Defined as death, MI, stroke, AAA rupture, conversion, secondary procedure, coronary 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:

Secondary Procedures through 60 months* 34 procedures in 26 patients Endoleak –23 (Cuffs, embolization, balloon dilatation) Endoleak –23 (Cuffs, embolization, balloon dilatation) Type II Endoleak – 17 Type II Endoleak – 17 Type I Endoleak – 6 Type I Endoleak – 6 Graft Limb Occlusion – 7 Graft Limb Occlusion – 7 Embolectomy,Stent, PTA, or Lytic Therapy Embolectomy,Stent, PTA, or Lytic Therapy Native Artery Procedures – 3 Native Artery Procedures – 3 Aortic Neck Dilation - 1 Aortic Neck Dilation - 1 * As of December 16, 2005

Conversion, Rupture, Migration through 60 months* Surgical conversions – 4 Surgical conversions – 4 Intraoperative – 3 Intraoperative – mo. – mo. – 1 Aneursym rupture – 0 Aneursym rupture – 0 5 Migrations (> 10mm) 5 Migrations (> 10mm) All caudal All caudal None leading to secondary procedure None leading to secondary procedure *As of December 16, 2005

Core Lab Analysis Endoleaks (All Types, New and Persistent) Core Lab Analysis Endoleaks (All Types, New and Persistent) 1 mo (N=123) 6 mo (N=119) 12 mo (N=147) 24 mo (N=123) 36 mo (N=109) 48 mo (N=64) 60 mo (N=16) All Endoleaks Type I Type I Type II Type II Type III Type III Type IV Type IV Multiple Multiple I ndeterminate As of December 16, 2005

Sac Diameter Over Time Sac Diameter Over Time As of December 16m 2005 * 192 patients enrolled, 3 patients CTs lost before submission to core lab Diameter (mm) Pre-op (N=189) * 12 mo (N=147) 24 mo (N=123) 36 mo (N=109) 48 mo (N=64) 60 mo (N=16) Mean(SD) 50.4(7.0)45.8(7.9)42.9(8.7)41.4(9.2)39.5(8.9)35.2(5.5) Minimum Maximum

Sac Volume Over Time Sac Volume Over Time As of December 16, 2005 * 192 patients enrolled, 3 patients CTs lost before submission to core lab ** Some CT scans are not evaluable for some parameters most often due to poor image quality, no contrast, CTs taken at greater than 3mm slices, etc. Volume (cc) Pre-op(N=187)* 12 mo (N=144) 24 mo (N=121) 36 mo (N=109) 48 mo (N=64) 60 mo (N=15) Mean(SD) 135.4(39.4)124.6(40.3)118.9(38.4)115.4(37.8)110.8(30.7)102.7(20.3) Minimum Maximum Unevaluable**

Morphology Change Sub-Analysis Method: Patients with paired data (both a 1-month and either a 2-year, 3-year, 4-year, or 5-year follow- up CT) as of December 16, 2005 were included in this analysis Patients with paired data (both a 1-month and either a 2-year, 3-year, 4-year, or 5-year follow- up CT) as of December 16, 2005 were included in this analysis Current Analysis N = 78 pts. Current Analysis N = 78 pts. All CTs were analyzed by study core lab utilizing proprietary 3-D reconstruction software (Medical Metrx Solutions, West Lebanon, NH) All CTs were analyzed by study core lab utilizing proprietary 3-D reconstruction software (Medical Metrx Solutions, West Lebanon, NH)

Analysis: Mean max. sac diameter Mean max. sac diameter Mean sac volume Mean sac volume Distance between distal renal and aortic bifurcation Distance between distal renal and aortic bifurcation Δ in maximum sac angulation Δ in maximum sac angulation Sac angle calculation was determined from distal proximal neck to maximum inflection point in the sac to aortic bifurcation (180° = straight line through sac) Sac angle calculation was determined from distal proximal neck to maximum inflection point in the sac to aortic bifurcation (180° = straight line through sac)

Overall Results: 1- Mo. 2-Yr.3-Yr.4-Yr.5-Yr. Mean Max. Sac Angle 144.1° ° 153.6° ° 158.4° Mean Max. Sac Diameter 50.5 mm 43.0 mm 41.8 mm 39.5 mm 35.2 mm Mean Aortic Volume ml ml 117.2ml ml ml Mean Distance Between Distal Renal & Bifurcation mm mm mm mm mm

Paired Results: 1-Mo. - 2-Yr. (n=70) 1-Mo. - 3-Yr. (n=67) 1-Mo. - 4-Yr. (n=39) 1-Mo. - 5-Yr. (n=6) % w/ Max. Sac Angle Becoming Straighter 78.6%82.1% 69.2 % 83.3 % Δ in Mean Max. Sac Angle Becoming Straighter 10.9° 11.8 ° 12.6 ° 12.7 ° % w/ Max. Sac Angle Same or Becoming More Angled 21.4%17.9% 30.8 % 16.7 % Δ in Mean Max. Sac Angle Same or Becoming More Angled -3.6 ° -6.9 ° -8.8 ° -18 ° Δ in Mean Length from Distal Renal to Bifurcation 2.3 mm 2.0 mm 1.9 mm 3.2 mm

Example: Pt. w/ 22.6° Straighter Sac Angle 1 – Mth.3 – Yr.

Distal End of Bifurcated Region

Summary of Late Clinical Findings 97.9 % Freedom from AAA-Related Mortality at 4 years with the Powerlink System 97.9 % Freedom from AAA-Related Mortality at 4 years with the Powerlink System No aneurysm ruptures No aneurysm ruptures Only 1 late conversion 1 yr.) Only 1 late conversion 1 yr.) No ePTFE graft material failures at 4 years No ePTFE graft material failures at 4 years No cobalt chromium stent graft failure or fatigue at 4 years No cobalt chromium stent graft failure or fatigue at 4 years

Conclusions: Powerlink System appears safe and effective in protecting patients from AAA rupture Powerlink System appears safe and effective in protecting patients from AAA rupture All cohorts treated w/ Powerlink ® experienced: All cohorts treated w/ Powerlink ® experienced: Aneurysm sac diameter & volume reduction Aneurysm sac diameter & volume reduction Remodeling or shrinking of aneurysm sac around device as evidenced by straightening of the aorta Remodeling or shrinking of aneurysm sac around device as evidenced by straightening of the aorta Minimal change in length of aorta from distal renal to bifurcation regardless of sac angle change Minimal change in length of aorta from distal renal to bifurcation 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 Powerlink ® may directly influence the classical remodeling of the aneurismal aorta The column strength and long main body of the Powerlink ® may directly influence the classical remodeling of the aneurismal aorta