History of the Powerlink System Design and Clinical Results. Edward B. Diethrich Arizona Heart Hospital Phoenix, AZ
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1 History of the Powerlink System Design and Clinical Results Edward B. Diethrich Arizona Heart Hospital Phoenix, AZ
2 Powerlink System: Unibody-Bifurcated Design Long Main Body Low-Porosity Proprietary eptfe Formulation Cobalt Chromium Alloy Stent Single-wire Main Body Construction Fully Supported
3 Powerlink System History AHI Arizona Heart Hospital
4 Powerlink System History 1999 Japanese Shonin Trial Begins 2000 U.S. Pivotal Trial Begins 2000 Powerlink Obtains CE Mark 2004 FDA Marketing Approval
5 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.
6 Powerlink U.S. Pivotal Trial (192 pts.) Powerlink Control P-value Age < Successful Deployment 188/ % N/A Patients with at least 1 Major AE (0-30days) N/A 13/ % 14/ % < All Death < 30 days 2*/ % 4/66-6.1% < Anesthesia Time (min) < Procedure Time (min) < Blood Loss (l) < Days in ICU < Days to Discharge < 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:
7 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
8 Freedom from AAA Mortality % Survival P= Powerlink Control Months Post-Implant Endologix U.S. Multicenter Trial
9 Endologix U.S. Multicenter Trial Freedom from Device Related Re-Hospitalization % Freedom from Device-Related Re-hospitalization Months Post- Implant
10 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 Type I Type II Type III Type IV Multiple Indeterminate As of April 30, 2007
11 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
12 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).
13 AAA Sac Regression - Diameter Diameter (mm) Month 6 Month 12 Month 24 Month 36 Month 48 Month 60 Month 72 Month Follow-up Months Endologix U.S. Multicenter Trial
14 Endologix U.S. Multicenter Trial AAA Sac Regression - Volume Volume (cc) Month 6 Month 12 Month 24 Month 36 Month 48 Month 60 Month 72 Month Follow-up Months
15 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 mm 43.0 mm 41.8 mm 39.5 mm 35.2 mm ml ml 117.2ml ml ml mm mm mm mm mm
16 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) % (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
17 Courtesy of Rod White, MD
18 Courtesy of Rod White, MD
19 Challenging Infrarenal Aortic Neck Anatomy Large diameter (>28mm) Short landing zone (<15mm) Extreme Angulation Accessory renal arteries Reverse tapered neck
20 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
21 Reverse Tapered Neck Sub-Group Analysis (50 of 192) Proximal Diameter mm ( ) Distal Diameter mm ( )
22 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
23 Summary of Late Clinical Findings 97.9 % Freedom from AAA-Related 6 yrs % Freedom from 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
24 Endologix New Product Developments
25 Visiflex SurePass Delivery System Contralateral Wire Access 0.14 Wire
26 Visiflex- Passage of 0.14 Wire Through Contralateral Limb Catheter
27 Visiflex IS Next Generation Delivery System Integrated 19 Fr Introducer Extensions deployed thru Integrated Sheath Hemostatic Clamp for Exchanges Simplified deployment Improved ergonomics
28 Ectatic Iliacs Aneurysmal Iliac Arteries >14mm in 20% of Patients
29 Large Diameter Limb Extensions Treats up to 23mm Iliacs
30 Challenging Necks Strong support from anatomical fixation Use existing Powerlink bifurcated stent grafts Develop dedicated cuffs for: Large necks Angulated necks Short necks
31 Cuff Concepts Flexibility Treats up to 32mm Neck Trans-Renal Alignment
32 Innovations- Type III Dissection with Vascular Compromise False Lumen True Lumen True Lumen Abdominal Pain Lower Leg Ischemia
33 Proximal ELG Deployed Persistent Distal True Lumen Compromise
34 Gianturco Stent with Barbs Without Barbs
35 Vascular Compromise Resolved
36 ELG Deployment of Bare Stents to Expand True Lumen Bare Stents
37 Petticoat Concept
38 Investigative Stent to Correct Vascular Compromise Endologix
39 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
40 History of the Powerlink System Design and Clinical Results Edward B. Diethrich Arizona Heart Hospital Phoenix, AZ
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