endologix nellixcritical-issues-congress.com/pdf/speakers_presentation/21-holden... · andrew...
TRANSCRIPT
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Andrew Holden Associate Professor of Radiology Auckland Hospital
Endologix Nellix: Can Nellix Repair All Para-renal Aneurysms?
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Disclosures Andrew Holden, MBChB, FRANZCR For the 12 months preceding this CME activity, I disclose the
following types of financial relationships: Honoraria received from: Nil
Consulted for:
Abbott Vascular Laboratories
Endologix Inc
Cook Medical Systems
480 Biomedical
Held common stock in: Nil
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A radically different endovascular system for AAA repair
Nellix Endovascular System
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Introduce both catheters over .035” wires
Balloon expand both stents (Chromium Cobalt)
Fill with Polymer using pressure monitoring
- Confidential -
Nellix Endovascular System
• Designed to fill and seal the entire aneurysm sac and target the direct causes of secondary
interventions
• Endobags filled with biostable polymer seal anatomy from renals to hypogastrics
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Ergonomic Handles
.035” Guidewire Lumen
Angio-Tip (Hand or Power Contrast
Injections)
Console Quick
Connects with Access
Ports
17 Fr OD Catheter
Nellix Endovascular System Delivery System
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Nellix Endovascular System Operator Console
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Nellix Endovascular System In-line Pressure Monitor
Sterile pressure transducer In-line design
Integrated display Real time monitoring
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Step 1: Introduce Devices
0915 hours
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Step 2: Withdraw Sheaths
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Step 3: Confirm Device Position
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Step 4: Deploy Stents
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Step 5: Fill Endobags with Polymer
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Step 5: Polymer Fill
• In-line pressure monitor
• Aim for endobag pressure 180mmHg
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0932 hours
Step 6: Device Removal
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Pre-contrast
Post-contrast
Thrombus, endobags (arrows) and stents easily seen
Nellix Endovascular System
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Can Nellix Repair All Para-renal Aneurysms?
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Can Nellix Repair All Para-renal Aneurysms?
No!
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• Address Challenging Proximal Neck Anatomies
• Shorter lengths (<10mm)
• Irregular (reverse conical)
Unique Nellix Features
Motivation for Endovascular Aneurysm Sealing
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Short Infra-renal Neck
• 5mm long neck
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Short Proximal Neck with “Posterior Bulge”
Challenging Neck Anatomies
Because the endobags are sealing the aneurysm, short and adverse
neck anatomies can be treated
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Note the superb apposition of endobags to the
dangerous posterior bulge in the infra-renal neck
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Pre-procedural CT Post-procedural CT
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Reverse Conical Neck
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• Treat Iliac Aneurysm Disease
• Avoid IIA occlusion or IBDs
Unique Nellix Features
Motivation for Endovascular Aneurysm Sealing
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Aneurysmal RCIA Nellix iliac extender preserving
hypogastric artery 6 month CT – RCIAA excluded
Iliac Artery Issues
Common Iliac Artery Aneurysms may be treated with an iliac
extender, avoiding hypogastric artery embolization or IBD
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Nellix Endovascular System
Endovascular Aneurysm Sealing Technology should
minimize the risk of all forms of endoleak (including
type 2) and graft migration
This could have a major impact on:
Secondary intervention rate
Frequency of surveillance
Procedural cost
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Prevention of Type 2 Endoleaks
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NELLIX GLOBAL CLINICAL EXPERIENCE – RESULTS
• Type 1A Endoleak resolved spontaneously within 60 days
• Type 1B Endoleak was due to improper device sizing (too short). A limb extension was added at 15 months which resolved the endoleak
• Type II Endoleak due to undersized endobag - resolved spontaneously within 60 days
Evaluation 30 Days
(N = 47)
6 Month
(n = 46)
1 YR
(n = 32)
2 YRS
(n = 23)
Rate of Secondary Procedures
(Endoleaks)
0 0 0 4.3% (1)
Aneurysm Rupture 0 0 0 0
Device Migration 0 0 0 0
Sac Expansion 0 0 0 0
Endoleak – Type 1A 2.1% (1) 0 0 0
Endoleak – Type 1B 2.1% (1) 2.2% (1) 3.1% (1) 0
Endoleak – Type II 2.1% (1) 0 0 0
Endoleak – Type III/IV 0 0 0 0
Stent Occlusion 0 0 0 0
Fracture or Fatigue 0 0 0 0
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Can Nellix Repair All Para-renal Aneurysms?
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Can Nellix Repair All Para-renal Aneurysms?
The Future?
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The endobag concept works could easily accommodate chimneys and snorkels
Nellix concept could extend to the thoracic aorta
Chimneys and Snorkels
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Branch Nellix Device Modified endobags with large fenestrations for branch arteries
Stents extend from the aortic lumen to the branch lumen to maintain patency
SMA Fenestration
Renal Fenestration
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The Future is Here!!