History of the Powerlink System Design and Clinical Results Edward B. Diethrich Arizona Heart Hospital Phoenix, AZ
Powerlink System: Unibody-Bifurcated Design Long Main Body Low-Porosity Proprietary eptfe Formulation Cobalt Chromium Alloy Stent Single-wire Main Body Construction Fully Supported
Powerlink System History 1995-96 Prototypes @ AHI Arizona Heart Hospital
Powerlink System History 1999 Japanese Shonin Trial Begins 2000 U.S. Pivotal Trial Begins 2000 Powerlink Obtains CE Mark 2004 FDA Marketing Approval
Anatomical Fixation Mimics the shape of the natural aorta Sits at the bifurcation Provides support to resist downward force due to pulsatile bloodflow Raithel, et al. Endovascular Today, June 2006.
Powerlink U.S. Pivotal Trial (192 pts.) Powerlink Control P-value Age 73.2 + 7.0 69.7 + 7.9 <0.0008 Successful Deployment 188/192 97.9% N/A Patients with at least 1 Major AE (0-30days) N/A 13/192-6.8% 14/66-21.2% <0.0020 All Death < 30 days 2*/192-1.0% 4/66-6.1% < 0.0389 Anesthesia Time (min) 185.1 + 82.2 293.8 + 111.5 <0.0001 Procedure Time (min) 135.9 + 65.9 222.3 + 100.1 <0.0001 Blood Loss (l) 0.34 + 0.41 1.58 + 1.6 <0.0001 Days in ICU 0.78 + 1.5 4.1 + 8.4 <0.0001 Days to Discharge 3.3 + 3.4 9.5 + 7.7 <0.0001 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;40:849-59.
Endologix U.S. Multicenter Trial 8 migrations through 72 mos. 1 secondary procedure (add l cuff) No clinical sequelae in 7 patients No aneurysm ruptures No wire fractures No graft material failures
Freedom from AAA Mortality 100 90 80 70 % Survival 60 50 40 30 P=0.1001 Powerlink Control 20 10 0 0 1 3 6 12 18 24 36 48 60 72 Months Post-Implant Endologix U.S. Multicenter Trial
Endologix U.S. Multicenter Trial Freedom from Device Related Re-Hospitalization % Freedom from Device-Related Re-hospitalization 100 80 60 40 20 0 0 1 3 6 12 18 24 36 48 60 72 Months Post- Implant
Endologix U.S. Multicenter Trial Core Lab Analysis Endoleaks (All Types, New and Persistent) 1 mo (N=123) 6 mo (N=119) 12 mo (N=147) 24 mo (N=142) 36 mo (N=130) 48 mo (N=119) 60 mo (N=72) 72 mo (N=16) All Endoleaks 25 13 18 12 8 10 8 1 Type I 1 0 0 0 0 0 0 0 Type II 20 13 15 10 7 8 6 1 Type III 0 0 0 0 0 0 0 0 Type IV 0 0 0 0 0 0 0 0 Multiple 2 0 1 0 0 0 0 0 Indeterminate 2 0 2 2 1 2 2 0 As of April 30, 2007
Secondary Procedures Through 72 Months* 34 procedures in 26 patients Endoleak 23 (Cuffs, embolization, balloon dilatation, stent) Type II Endoleak 17 Type I Endoleak 6 Graft Limb Occlusion 7 Embolectomy, Stent, PTA, or Lytic Therapy Native Artery Procedures 3 Migration - 1 * As of April 2007 Endologix U.S. Multicenter Trial
Endologix U.S. Multicenter Trial AAA Sac After EVAR Decrease in volume in 83% of pts. by 60 months 6 patients with volume expansion 4 Type II endoleaks were reported in patients with volume expansion (none of which resulted in secondary procedures).
AAA Sac Regression - Diameter 70.0 60.0 50.0 40.0 30.0 20.0 Diameter (mm) 10.0 0.0 1Month 6 Month 12 Month 24 Month 36 Month 48 Month 60 Month 72 Month Follow-up Months Endologix U.S. Multicenter Trial
Endologix U.S. Multicenter Trial AAA Sac Regression - Volume Volume (cc) 180.0 160.0 140.0 120.0 100.0 80.0 60.0 40.0 20.0 0.0 1Month 6 Month 12 Month 24 Month 36 Month 48 Month 60 Month 72 Month Follow-up Months
Courtesy of Rod White, MD Sac Dynamics After Powerlink 1- Mo. 2-Yr. 3-Yr. 4-Yr. 5-Yr. Mean Max. Sac Angle Mean Max. Sac Diameter Mean Aortic Volume Mean Distance Between Distal Renal & Bifurcation 144.1 151.6 153.6 154.7 158.4 50.5 mm 43.0 mm 41.8 mm 39.5 mm 35.2 mm 137.0 ml 118.9 ml 117.2ml 110.8 ml 102.7 ml 118.5 mm 121.6 mm 122.0 mm 124.4 mm 122.8 mm
Courtesy of Rod White, MD Sac Dynamics After Powerlink 82.8 % (n = 53/64) of patients exhibited an increase in sac angle (aorta becoming straighter) -39.0 % (n = 25/64) of patients exhibited straightening by 10 or more 17.2 % (n = 11/64) of patients exhibited no change or had a slight decrease in sac angle (aorta becoming more angulated) -3.1 % (n = 2/64) of patients exhibited angulation decreasing by 10 or more
Courtesy of Rod White, MD
Courtesy of Rod White, MD
Challenging Infrarenal Aortic Neck Anatomy Large diameter (>28mm) Short landing zone (<15mm) Extreme Angulation Accessory renal arteries Reverse tapered neck
Objective Evaluate the incidence of Type I endoleaks and device migration in patients with reverse tapered neck anatomy Determine effect on seal zone Incidence of secondary interventions in patients with this neck geometry
Reverse Tapered Neck Sub-Group Analysis (50 of 192) Proximal Diameter 20.94 mm (17.9--26.0) Distal Diameter 24.38 mm (21.5 28.6)
Follow-up of Sub-Group Mean follow-up: 40.2 months Range: 1 mo 64 mo No AAA-related deaths No secondary procedures for proximal Type I endoleak Graft migration: 1 (12.5mm); no clinical sequelae
Summary of Late Clinical Findings 97.9 % Freedom from AAA-Related Mortality @ 6 yrs. 82.5 % Freedom from Re-hospitalization @ 6 yrs. No aneurysm ruptures Only 1 late conversion (@ 1 yr.) No eptfe graft material failures at 6 years No cobalt chromium stent graft failure or fatigue at 6 years
Endologix New Product Developments
Visiflex SurePass Delivery System Contralateral Wire Access 0.14 Wire
Visiflex- Passage of 0.14 Wire Through Contralateral Limb Catheter
Visiflex IS Next Generation Delivery System Integrated 19 Fr Introducer Extensions deployed thru Integrated Sheath Hemostatic Clamp for Exchanges Simplified deployment Improved ergonomics
Ectatic Iliacs Aneurysmal Iliac Arteries >14mm in 20% of Patients
Large Diameter Limb Extensions Treats up to 23mm Iliacs
Challenging Necks Strong support from anatomical fixation Use existing Powerlink bifurcated stent grafts Develop dedicated cuffs for: Large necks Angulated necks Short necks
Cuff Concepts Flexibility Treats up to 32mm Neck Trans-Renal Alignment
Innovations- Type III Dissection with Vascular Compromise False Lumen True Lumen True Lumen Abdominal Pain Lower Leg Ischemia
Proximal ELG Deployed Persistent Distal True Lumen Compromise
Gianturco Stent with Barbs Without Barbs
Vascular Compromise Resolved
ELG Deployment of Bare Stents to Expand True Lumen Bare Stents
Petticoat Concept
Investigative Stent to Correct Vascular Compromise Endologix
Powerlink System - Conclusions Excellent results in challenging neck anatomy Simple implantation technique Minimally invasive access Anatomical fixation for resistance to migration Low occurrence of secondary procedures Low occurrence of Type II endoleaks Sac regression and improving morphology Proven durability Innovative product pipeline for expanding EVAR indications
History of the Powerlink System Design and Clinical Results Edward B. Diethrich Arizona Heart Hospital Phoenix, AZ