Endovascular Aneurysm Sealing (EVAS) for Simple and Complex AAAs

Andrew HoldenAuckland, New Zealand

November 16th 2017

The Incidence of Type 1A EL after Nellix EVAS is Low

How to Prevent Them and How Best to Treat Them

AndrewHolden,MBChB,FRANZCR,EBIRDirectorofInterventionalRadiologyAuckland,NewZealand

Nellix:LessonsLearnedfromtheEVASForwardGlobalRegistryandtheFutureRoleofPolymerSealinginAAAManagement

LINC2018

Disclosures and Disclaimers

Andrew Holden MBChB, FRANZCR, EBIR

Clinical Investigator and Advisory Board Member

Endologix Inc.

DisclosureSpeakername: AndrewHolden.

Ihave the following potentialconflicts ofinterest to report:

Consulting

Employment inindustry

Stockholderofahealthcare company

Owner ofahealthcare company

Other – ClinicalInvestigator forELGX

Idonothaveanypotentialconflictofinterest

X

Concept of EndoVascular Aneurysm Sealing

(EVAS) with Nellix®

Different method of aneurysm treatment with “active sac management”

Analogous to open surgical repair with sac ablation

Aim is to prevent endoleak of any type

So how has it performed, what are the lessons learned and what is it’s potential in the future?

2014 2015 2016 20172008-2012 2013

N=30030 Centers(29 EU, 1 NZ)

EnrollmentCompletedSept, 2014

2 YR FU1 YR FU 3 YR FU

N=18029 Centers (26 US, 3 EU)

Enrollment Completed Nov, 2014

PMASubmission

Continued Access

30 DAY FU 1 YR FU

No prospective screening, procedural steps not optimized

Strict IFU compliance, procedural steps evolved

Validating EVAS with Clinical Data

2 YR FU

Spontaneous Resolution of Type II Endoleak

Low Volume 0.1 – 0.4 mL

1 Yr

99.2%

97.0%

IncidencePersistence

Freedom From Type II Endoleak

Freedom From Type II Endoleak

No Secondary Interventions for Type II Endoleak

Freedom From All Persistent Endoleak @ 2 Years

98.1%

AllEndoleak 1.8% (5)(N=277)

TypeIa 0.4%(1)

TypeIb 0.4%(1)

TypeII 0.7%(2)

TypeIII -

TypeUnknown 0.4%(1)

Meanfollow-up25mo (0-35mo)

Similar Positive Results - EVAS FORWARD IDE @ 2 Years

99% FREEDOM FROM

RUPTURE

97%FREEDOM FROM

TYPE II EL

Freedom from Type II Endoleak Freedom from Rupture

Similar Positive Results - EVAS FORWARD IDE @ 2 Years

99% FREEDOM FROM

CARDIOVASCULAR MORTALITY

94%FREEDOM FROM

ALL CAUSE MORTALITY

Freedom from ACM Freedom from CVM

Cross Trial Comparison @ 1 Year

IFU compliance does influence re-intervention

Continued Evolution of Nellix ® EVAS

Despite the excellent results @ 2 years, late complications noted in clinical practice and trials, predominantly after 2 years

These are migration, type IA endoleak and aneurysm sac growth

To mitigate these complications, there has been evolution in the procedure, device and IFU

Continued Evolution of Nellix ® EVAS

1 1 2 2 2

7

33

57

85

2009 2010 2011 2012 2013 2014 2015 2016 2017

Nellix EVAS: A Procedure in Evolution

Patient SELECTION

Proper POSITIONING of the Nellix Device

Establishment of a Durable SEAL

Nellix EVAS: A PROCEDURE in Evolution

• Inflate Nellix balloons to nominal pressure (7 ATM) for AT LEAST 30 seconds

• Leave balloons up during unfurling, pre-fill and polymer – avoids stent displacement and bowing

Nellix EVAS: A PROCEDURE in Evolution

Complete endobag filling is vital to achieve optimum seal

Unfurling of the endobag before deployment of the stents allows optimum endobag conformability

Pre-fill of the endobags after stent deployment with dilute contrast saline allows optimum positioning and calculation of endobag fill volume

Unfurling Contrast-saline Pre-fill Contrast-saline Pre-fill Polymer fill

Nellix EVAS: A DEVICE in Evolution

≥ 10mm seal

Revised Anatomic IFU for Most Predictable Outcomes96% 2 YEAR FREEDOM FROM TYPE IA ENDOLEAK, MIGRATION, OR SAC GROWTH

IFU REFINEMENT AND TYPE IA ENDOLEAK

IFU Impact on Longer Term Data

Single Centre audit of 115 consecutive cases

Auckland Hospital

Minimum follow up 2 years

Mean follow up 3.5 years

Freedom from Type 1A Endoleak

Prospective Evaluation of Revised IFU

1

SiteActivationandEnrollmentStatus(11/10/2017)

Phase 2:StartUpphase:28

Phase3:SiteInitiationScheduled:

Phase 4:SIVcompleted:18(2Sitesdropped) Patients Enrolled(20)

Europe28

(including 2SPNand1SW) 0 15(Active) 11

AsiaPacific12

(including 7AUZsites) 1 (datepending) 1(Active) 9

Site# AccountName/SiteName Country No.ofPatients

Enrolled

Site# AccountName/SiteName Country No.ofPatients

Enrolled

104 AucklandCityHospital NewZealand 9 133 UniversityHospitalKoeln Germany 1

120 ArnhemHospital Netherlands 3 134 TUHMunich Germany 1

123 StElisabethHospitalTilburg Netherlands 2 135 HospitalAugsburg Germany 1

124 StAntoniusHospitalNieuwegein Netherlands 0 136 Klinikum Stuttgart Germany 0

130 UniversityHospitalHeidelberg Germany 0 160 UniversityHospitalRiga Latvia 0

131 Alfried-KruppHospitalEssen Germany 0 139 Marienhospital Osnabrueck Germany 0

110 StGeorge’sLondon UK 0 192 Marienhospital Bonn Germany 2

142 UniversityHospitalValencia Spain 1 143 LaCoruna Spain 0

300 patient trial in Europe and Asia-Pacific

Follow up out to 5 years

FirstGlobalFORWARD2RegistryPatient

Pre 1Month 6Months 1Year

1Year

Up to 90 patients , 28 US sites

Follow up out to 5 years

Vikram Rao

University Hospitals

Cleveland, OH

Chris Healey

Maine Medical

Portland, ME

Jose Trani

Cooper Hospital

Camden, NJ

Homayoun Hashemi

Inova Fairfax

Fairfax, VA

Sajjad Hussain

St. Vincent Hosp.

Indianapolis, IN

Huey McDaniel

Sacred Heart

Pensacola, FL

Satish Muluk

Allegheny General

Pittsburgh, PA

James Benenati

Miami Vascular

Miami, FL

Venkatesh, Ramaiah

Arizona Heart Hospital

Phoenix, AZ

John Lane

VA San Diego

San Diego, CA

Robert Cuff

Spectrum Health

Grand Rapids, MI Lee Kirksey

CCF

Cleveland, OH

Chris Kwolek

Mass General

Boston, MA

William Quinones

UCLA

Los Angeles, CA

James McKinsey

Mount Sinai

New York, NY

Marc Schermerhorn

Beth Israel Deaconess

Boston, MA

Andres Fajardo

Indiana University

Bloomington, IN

Mark Mewissen

Aurora St. Luke's

Milwaukee, WI

Dan Clair

USC Palmetto

Charleston, SC

Nelson Bernardo

Medstar Wash

Washington DC

Fred Stucky

Huntsville Med Center

Huntsville, AL

Manuel Perez-Izquierdo

Florida Hospital

Orlando, FL

Scott Kujath

No Kansas City Hospital

Kansas City, MO

Mark Farber

UNC

Chapel Hill, NC

Stephen Murray

Providence Sacred Heart

Spokane, WA

Brant Ullery

Providence St. Vincent’s

Portland, OR

Caution:TheNellixEndoVascularAneurysmSealingSystemisaninvestigationaldeviceintheUnitedStates,limitedbyfederal(orUnitedStates)lawtoinvestigationaluseonly. MM1828Rev.01

Endovascular Bailout Options Now Approved

Patients who are on the revised IFU:o Part of a clinical trial

o Expect outstanding outcomes in terms of freedom from any endoleak, migration and re-intervention

o Morbidity/mortality benefits of “active aneurysm sac”

Patients with large aortic side branches (high risk of T2EL):

So, Who Do I Treat with Nellix in 2018?

1

SiteActivationandEnrollmentStatus(11/10/2017)

Phase 2:StartUpphase:28

Phase3:SiteInitiationScheduled:

Phase 4:SIVcompleted:18(2Sitesdropped) Patients Enrolled(20)

Europe28

(including 2SPNand1SW) 0 15(Active) 11

AsiaPacific12

(including 7AUZsites) 1 (datepending) 1(Active) 9

Site# AccountName/SiteName Country No.ofPatients

Enrolled

Site# AccountName/SiteName Country No.ofPatients

Enrolled

104 AucklandCityHospital NewZealand 9 133 UniversityHospitalKoeln Germany 1

120 ArnhemHospital Netherlands 3 134 TUHMunich Germany 1

123 StElisabethHospitalTilburg Netherlands 2 135 HospitalAugsburg Germany 1

124 StAntoniusHospitalNieuwegein Netherlands 0 136 Klinikum Stuttgart Germany 0

130 UniversityHospitalHeidelberg Germany 0 160 UniversityHospitalRiga Latvia 0

131 Alfried-KruppHospitalEssen Germany 0 139 Marienhospital Osnabrueck Germany 0

110 StGeorge’sLondon UK 0 192 Marienhospital Bonn Germany 2

142 UniversityHospitalValencia Spain 1 143 LaCoruna Spain 0

Patients who concomitant iliac aneurysm disease:o Short common iliac arteries

o CIA aneurysms with preservation of the internal iliac artery

So, Who Do I Treat with Nellix in 2018?

Patients with failed EVAR and open repair:o Endobag sealing excellent treatment for T1 and T3 endoleaks

o Two tube repair particularly suitable for short body grafts (avoids AUI)

So, Who Do I Treat with Nellix in 2018?

Type 1A Endoleak Repair - ChEVAS

Andrew Holden MD, Auckland NZ

Endurant

So, Who Do I Treat with Nellix in 2018?

Hostile neck anatomy with ChEVAS:o Especially patients declined for FEVAR or need urgent treatment

More imaginative use of parallel grafts:

Conclusions

EVAS is a disruptive technology providing unique “active sac management”

Not surprisingly, there have been challenges in achieving a durable seal but these are now well understood with strategies to avoid and treat complications now developed

Outstanding results should be possible with compliance with the revised IFU – this will be prospectively tested in EVAS FORWARD 2 and EVAS 2 IDE

There are some clear indications for EVAS in 2018

Exciting developments in the future

Endovascular Aneurysm Sealing (EVAS) for Simple and Complex AAAs

Andrew HoldenAuckland, New Zealand

November 16th 2017

The Incidence of Type 1A EL after Nellix EVAS is Low

How to Prevent Them and How Best to Treat Them

AndrewHolden,MBChB,FRANZCR,EBIRDirectorofInterventionalRadiologyAuckland,NewZealand

Nellix:LessonsLearnedfromtheEVASForwardGlobalRegistryandtheFutureRoleofPolymerSealinginAAAManagement

LINC2018