Time to Personalize AAA Repair

Matt Thompson

Disclosure

Speaker name: Matt Thompson, MD

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I have the following potential conflicts of interest to report:

Consulting

Employment in industry – Endologix, Inc., Chief Medical Officer

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

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ANCURE LIFEPATH VANGUARDANEURYX

EVAR Open % EVAR

2011 2982 1493 66%

2012 2976 1426 68%

2013 3062 1350 69%

2014 3123 1251 75%

2015 2882 1316 68%

VSQIP: AAA UK EVAR AND OPENAdoption of EVAR in UK

Schumerhorn et al NEJM 2015;373: 328

(5.4%rAAA / 8y)

Freedom from Rupture or Reintervention

Aneurysm Related Mortality

Greenhalgh et al Lancet 2016; 388: 2366

Aneurysm Related Mortality

63% of patients had one or more Hostile Neck features

Prospective, single center US study of 258 EVAR patients treated over an 8 year period

Conclusion: Patients with HNA can be treated with EVAR, but with higher rates of early (intraop) type I

endoleak and reintervention

Relationship Between Neck Anatomy and Outcome

Complication Rates Related to Aortic Morphology

Karthikesalingam et al PLOS One 2015 10 (7)

Complication Rates Related to Aortic Morphology

“Fit the patient to the endograft not the

endograft to the patient”

…with medical decisions, practices, and/or products being tailored to the individual patient

Personalized medicine proposes the customization of healthcare…

11The Nellix® EndoVascular Aneurysm Sealing System is an investigational device in the United States, limited by federal (or United States) law to investigational use only

The AFX graft is currently unavailable in the EU

● ● ●

Short Necks ●

Thrombus-Laden Neck ● ●

Calcific Neck ●

Reverse Taper Necks ● ●

Infrarenal placement ● ●

Small Access Vessels ● ●

Tortuous/Calcified ●

Preservation of Bifurcation ●

Narrow Distal Aorta ●

Patent IMA/Lumbars ●

Short Common Iliac ● ●

Concomitant Iliac Aneurysm ●

Aortic Neck Challenges

Access Challenges

Aneurysm Characteristics

Standard Anatomy

SELECT THE OPTIMAL GRAFT FOR ON-IFU TREATMENT

12

The Nellix® EndoVascular Aneurysm Sealing System is an investigational device in the United States,

limited by federal (or United States) law to investigational use only

Endologix products and associated components are not available in all countries or regions. Please contact your Endologix representative for details regarding product availability. Prior to use, refer to the “Instructions for Use” for complete and specific indications, contraindications, all warnings and precautions. Rx only.

Low profile endografts

Lowest profile of any EVAR device (14F OD)

Widest applicability on IFU (69%)

Good evidence base (IDE / EU PMR / LIFE / LUCY)

Excellent clinical results

OVATION Alto Launch

OVATION

SMALL ACCESS (<6mm)

60%

SHORT NECK

(<10mm) 20%

BOTH20%

40% COMPLEX ANATOMIES

Major Adverse Events*

97%

Freedom from

OcclusionFreedom from TIa EL Reintervention

97%

Freedom from Rupture

99%3.8%

* At 1 year

OVATION®

GLOBAL PIVOTAL TRIAL5 Year Results

Freedom from ARM*

98%

Freedom from Conversion

100%

161 patients enrolled in Chile, Germany and USA from Nov 2009 – Dec 2011

1/3 of patients had Severe Morphology

(150/501) patients had small access vessels, short, wide, or

angulated necks, or severe neck thrombus or calcification

Data provided by site imaging. Severe morphology based on SVS/AAVS anatomic scoring. Chaikof et al. J Vasc Surg 2002;35:1061-1066 / Walker et al. J Vasc Interv Radiol 2010;21:1632-1655

Aortic Morphology – Ovation European Post Market Registry

Introducing a New Therapy – EVAS is not EVAR

New therapy, potentially disruptive

Active sac management

All endografts have a failure mode

Mechanisms of EVAS failure becoming defined

Identify “sweet spot” for Nellix

The Nellix® EndoVascular Aneurysm Sealing System is an investigational device in the United States, limited by federal (or United States) law to investigational use only

Active Management Aneurysm Sac – Endoleak Rate

IncidencePersistence

99.2%

97.0%

Type 2 Endoleak – Global Registry

Active Sac Management and Type 2 Endoleak

The Nellix® EndoVascular Aneurysm Sealing System is an investigational device in the United States, limited by federal (or United States) law to investigational use only

Active Management Aneurysm Sac – Endoleak Rate and PIS

EVAS (63) EVAR (41)

PIS (%) 4.9 20.6

CRP (mg/l) 6.6 15.4

WCC 9.7 13.4

Data courtesy P Berg

ACM98.5%

89.6%

99% Freedom from CardiovascularMortality through 2 Years

CVM

EVAS and Biologic Response to AAA Repair

The Nellix® EndoVascular Aneurysm Sealing System is an investigational device in the United States, limited by federal (or United States) law to investigational use only

Nellix Stent Migration (Polymer and Thrombus)

Seal zone

engagement

Thrombus

volume and

stability

Polymer

thickness and

distribution

Resistance to Migration

Stiffness of stent

graft

The Nellix® EndoVascular Aneurysm Sealing System is an investigational device in the United States, limited by federal (or United States) law to investigational use only. The Nellix® EndoVascular Aneurysm Sealing System approved to treat infrarenal abdominal aortic aneurysms and is not approved for any other intended use in any geography.

Maximum Aortic Aneurysm Diameter

Maximum Aortic Blood Lumen Diameter

Max aortic aneurysm dia

Max aortic blood lumen dia

< 1.4

Aneurysm Ratio

Analysis

complete