UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A
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ENDOLOGIX, INC.
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EXPLANATORY NOTE
Filed Documents
This filing consists of the following documents relating to the proposed acquisition of Nellix, Inc. by Endologix, Inc.:
Exhibit A: PowerPoint slides used at Conference Call held on October 27, 2010.
Exhibit B:
Materials posted to Endologix, Inc.s Website.
Additional Information About the Proposed Transaction and Where to Find It
This presentation may be deemed soliciting material relating to the proposed transaction between Endologix, Inc. and Nellix, Inc. In
connection with the proposed transaction, Endologix, Inc. will file a proxy statement and other relevant documents with the Securities and Exchange Commission.
INVESTORS AND SECURITY HOLDERS ARE ADVISED TO READ THE PROXY STATEMENT AND THESE OTHER
DOCUMENTS WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT ENDOLOGIX, INC. AND THE PROPOSED TRANSACTION
. Investors and security holders may obtain a free copy of the proxy statement (when available) and other
relevant documents filed by Endologix, Inc. with the Securities and Exchange Commission at the Securities and Exchange Commissions Web site at www.sec.gov.
The proxy statement and other relevant documents are also available for free on Endologix, Inc.s website at www.endologix.com under Investor Relations/Financial Information/SEC Filings
or by directing such request to Investor Relations, Endologix, Inc., (949) 595-7283.
Endologix, Inc. and its directors and executive
officers may be deemed to be participants in the solicitation of proxies from the stockholders of Endologix, Inc. in connection with the proposed transaction. Information concerning the interests of Endologix, Inc.s participants in the
solicitation is set forth in Endologix, Inc.s proxy statements and Annual Reports on Form 10-K, previously filed with the Securities and Exchange Commission, and in the proxy statement relating to the proposed transaction when it becomes
available.
1
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EXHIBIT A
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ENDOLOGIX
Innovation Taking Shape
Third Quarter 2010
Results and
Nellix Acquisition
October 27, 2010
ENDOLOGIX
Safe Harbor
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, statements relating to the
potential benefits of Endologix, Inc.s proposed acquisition of Nellix, Inc., including expected operating synergies, the strength of Nellix, Inc.s technology and the potential for long-term growth and expanded market share. Endologix,
Inc. intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Exchange Act and the Private Securities Litigation Reform Act of 1995. These statements are
based on the current estimates and assumptions of Endologix, Inc.s management as of the date of this presentation and are subject to risks, uncertainties, changes in circumstances and other factors that may cause actual results to differ
materially from the forward-looking statements made in this presentation. Important factors that could cause actual results to differ materially from forward-looking statements include, but are not limited to, risks relating to the ability to
consummate the proposed acquisition, the ability to successfully integrate the Nellix technology with its current and future product offerings, the scope of potential use of the Nellix technology, the ability to obtain and maintain required U.S.
Food and Drug Administration and other regulatory approvals of the Nellix technology, the scope and validity of intellectual property rights applicable to the Nellix technology, the ability to build a direct sales and marketing organization in
Europe, competition from other companies, the ability to successfully market and sell its products, plans for developing new products and entering new markets and additional factors that may affect future results which are detailed in Endologix,
Inc.s Annual Report on Form 10-K filed with the SEC on March 3, 2010, and in Endologix, Inc.s other periodic reports filed with the SEC. Endologix, Inc. undertakes no obligation to revise or update information herein to reflect
events or circumstances in the future, even if new information becomes available.
ENDOLOGIX
3Q 2010 Results
Revenue of $17.9 million, up 30% y/y
Domestic
revenue $15.3 million
International revenue $2.6 million
Gross margin of 79%
Net loss of $466,000 or $0.01 per share
Includes
$1.4 million of legal and business development
Cash flow positive
Cash and cash equivalents of $22.9 million
Guidance update:
2010 Revenue $66 - $67 million
(26% - 28% growth)
ENDOLOGIX
Driving for Market Leadership
Innovation leader in AAA with strong momentum towards aortic market leadership
Continuing to invest for growth in a highly competitive market
Larger, strengthened sales force
R&D programs
focused on expanding addressable market
Demonstrated ability to execute and gain market share
ENDOLOGIX
Nellix Acquisition Highlights
Provides ELGX with next generation EVAR technology platform
Potential to reduce secondary interventions, long-term surveillance, radiation exposure and healthcare costs
Simple and intuitive procedure steps
Treats more
anatomies than other AAA devices
Expands AAA market
Broadest expected indication of all EVAR devices
European sales force
Expected to accelerate
revenue growth and increase gross margins
Essex Woodlands investment
ENDOLOGIX
Current EVAR Limitations
Secondary interventions are required in 18 20% of EVAR patients
Requires lifetime surveillance
Higher mortality
~60% of secondary interventions are caused by endoleaks1
Nellix device is the only EVAR technology that seals the AAA sac and has the potential to eliminate endoleaks
1Mehta M, Sternbach Y, Taggert JB, et al. Long-term outcomes of secondary procedures after endovascular aneurysm repair. J
Vasc Surg 2010 (in press). Data reported as % of post-EVAR secondary interventions.
ENDOLOGIX
Technology Overview
Highly Differentiated Aneurysm Filling/Sealing Platform
Endobags are filled with a biostable polymer
Integrated Endoframes pave blood flow lumens to the legs
Next Gen Anatomic Fixation
Conforms, seals and stabilizes all AAA anatomies
No need for barbs, hooks or continuous radial expansion from oversized self expanding stents
ENDOLOGIX
Nellix Implant Procedure
Unexpanded Endoframes
Expanding Endoframes
Polymer Filled Endobag
Completion Angiogram
ENDOLOGIX
100% Aneurysm Exclusion
9
ENDOLOGIX
Exceptional Clinical Results
34 Patients (follow up to 2 years)
Over 50%
of implants are outside the indications for other EVAR devices
Minimal endoleaks and secondary interventions
with 1st generation device
100% freedom from AAA-related mortality
No aneurysm ruptures
No stent graft migration
Strong physician
feedback
10
ENDOLOGIX
Nellix Physician Feedback
Product / Technology
Has the capability to treat
a wide range of anatomies
Short / no neck AAAs
Large diameter necks
Aneurismal iliac
Hypogastric preservation
Procedure
Simple, intuitive steps
Predictable procedure
times and outcomes for both simple and complex anatomies
Limited training required
Highly Adoptable
Market Expansion
Expected Impact
Reduce endoleaks and secondary interventions
Potential to reduce long-term surveillance, radiation exposure and healthcare costs
More physicians capable of handling complex cases
Improved Outcomes + Widespread Adoption
11
ENDOLOGIX
AAA Competitive Landscape
Company
Device
Profile
Neck Length
Neck Diameter
ELGX
AFX
19F
15mm
32mm
MDT
Endurant
18F20F
10mm
32mm
Cook
Zenith LP
16F18F
15mm 32mm
Gore
Repositionable
18F20F
15mm 29mm
Trivascular
Ovation
14F15F
7mm 32mm
Nellix
Nellix*
18F19F
5mm 34mm
JNJ
Incraft 1
4F
15mm
32mm
Terumo
Anaconda
21F23F
15mm
32mm
Nellix can treat more AAA anatomies than other EVAR devices and is the only device that completely seals the aneurysm sac
*Expected profile and neck capabilities in IDE device
12
ENDOLOGIX
EU 2010 EVAR Market
¡
Large growing market with good historical adoption of new vascular technology (perc valves, etc)
¡
Nellix + ELGX new product portfolio depth provides ideal timing to
establish direct channel
$4.6M
$140M
EU EVAR Market
ELGX Sales
13
ENDOLOGIX
ELGX Planned New Product Pipeline
IntuiTrak New Sizes Europe
AFX U.S.
Nellix Europe
PEVAR U.S.
Ventana Europe
Xpand Europe
AFX2 U.S.
Aortic Stent Europe
Ventana U.S.
Nellix U.S.
2011
2012
2013
2014
2015
IntuiTrak New Sizes International
IntuiTrak
Japan
Nellix International
Ventana International
Xpand International
Aortic Stent International
Xpand U.S.
17 new product launches planned over the next 4-5 years
14
ENDOLOGIX
ELGX Market Opportunities
Infrarenal
Juxtarenal
Thoracic
2015
$400M
$300M
$1B
Aortic Stent
Ventana
$1.7B
AFX
TAA Stent Graft
Xpand
PEVAR
Nellix
15
ENDOLOGIX
Acquisition Agreement
All stock transaction
At closing Essex Woodlands
will invest $15M
2 ELGX board seats
Estimated 11% dilution at initial deal closing
Deal Structure
Upfront Stock at Closing $15M 30%
Milestones
$10M OUS sales (TTM) $20M* 40%
PMA Approval $15M
30%
Total $50M 100%
* Ranges from $24M to $10M based on time to achieve
70% of consideration based upon commercial and regulatory success
16
ENDOLOGIX
Essex Med Tech Portfolio
Early Stage PIPE Late Stage
17
ENDOLOGIX
Transaction Milestones
Anticipated Timing:
2011 2012 2013 2014 2015
Technology transfer to ELGX
Build EU direct sales organization
Nellix
International launch
U.S. IDE clinical trial
PMA approval
US launch
EU Launch
Enrollment
18
ENDOLOGIX
Anticipated ROI
Incremental revenue starting in 2011 with
estimated 2016 Nellix revenue of ~$100M
At 3.5X sales = $350M potential increase in 2016
market cap
Direct EU sales force to capture
market share
and leverage full ELGX product line over time
Improved OUS margins
Back-end loaded structure mitigates
technology
and regulatory risks
19
ENDOLOGIX
Financial Guidance
2011 revenues of $78M - $82M
2011 loss of $0.25 -
$0.30 per share
Nellix R&D: ~$13.0M or ($0.23)
EU Sales Force: ~$5.7M or ($0.10)
Deal Amortization & Integration: ~$2.2M or ($0.04)
Expect core business profitability in 2011
Expect
total company profitability by Q4 2012
Operating margins of 25% - 30% by 2015
Forecasted Sales CAGR of 25%+ (2011-2015)
Note: Assumes Nellix Acquisition closes in 2010.
20
ENDOLOGIX
Post Acquisition Balance Sheet
ASSETS
Cash $40M
Total Current Assets $60M
Net Fixed Assets $3M
Goodwill &
Intangibles $47M
TOTAL ASSETS $110M
LIABILITIES & EQUITY
Total Current
Liabilities $12M
Long Term Liabilities $1M
Total Liabilities $13M
Total Equity $97M
TOTAL LIABILITIES &
EQUITY $110M
Strong cash position to execute growth strategy
21
ENDOLOGIX
Nellix Acquisition Summary
Strategic Drivers
Compelling Factors
Most promising & disruptive new EVAR technology
Addresses the limitations of current devices
Market expanding
Excellent growth opportunity for
ELGX
Nellix strengthens & complements ELGX pipeline
Simple, intuitive procedure
Physician pull anticipated
Robust new product
pipeline provides compelling opportunity to establish an EU direct sales
Proven management capability to
integrate and execute
Well structured stock deal with success based milestones
ELGX and Nellix management are well positioned to capitalize on the Nellix technology
Combination of ELGX and Nellix creates a company with market leadership potential
22
ENDOLOGIX
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EXHIBIT B
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Endoluminal Aortic Aneurysm Repair Using Sac Anchoring Endoprosthesis
Single Center Experience in Latvia
Dainis Krievins, MD and J. Savlovskis, K. Kisis, M. Gedins, C. Donayre, C. Zarins
Pauls Stradins University Hospital Riga, Latvia
International Congress
Phoenix, Arizona
March 2010
Unresolved problems with EVAR
Many patients have unsuitable aortic neck and iliac anatomy
and thus are not candidates for EVAR
Persistent
and new onset endoleaks
Aneurysm enlargement, secondary procedures
Long-term positional instability
Migration, secondary procedures, risk of rupture
The Nellix Endoprosthesis
A new sac-anchoring device
Not dependent on
proximal and distal fixation mechanisms
Obliterates aneurysm sac, eliminating endoleaks
Sac Anchoring Endoprostheses
Endobag
Stainless Steel Endoframes
Polymer Filled Endobags
Device implantation
Unexpanded endoframes
Expanded endoframes (flow
channel)
Polymer filled endobag
Completion angiogram
Purpose
To review our initial experience using the Nellix sac anchoring endoprosthesis in patients with
favorable
unfavorable anatomy
All patients signed informed consent and were enrolled in an IRB-approved prospective clinical trial
Follow-up included CT scans at 30, 180 and 360 days
Case example
favorable anatomy, small aneurysm
pre
post
1 month CT scan
Case example
favorable anatomy, large aneurysm
1 mo
6 mo
1 year
Case example
unfavorable anatomy, short, angulated neck
6
month CT scan
Case example
bilateral common iliac artery aneurysm
Pre
Post
Case example
unfavorable anatomy, funnel neck, iliac aneurysm
3.5 cm CIA.
Nellix iliac extender Internal iliac flow preserved
Case example
short angulated neck & dilated common iliac arteries
Iliac aneurysm
Nellix iliac extender
Internal iliac patent
Patient population
16 patients treated from 2008-2009
Age
68±9 years (range 53-83 years)
Comorbidities:
- CAD 7 (44%)
- Hypertension 9 (56%)
- DM 2 (13%)
- Smoking 3 (19%)
- COPD 3 (19%)
Aneurysm Morphology
Aortic aneurysm
AAA diameter: 6.0±0.7 cm
(4.3-7.2 cm)
Lumen diameter 43±7 mm (33-55 mm)
Neck morphology
Diameter 23±3 mm (17-31 mm)
Length
19±12 mm (5-35 mm)
Angle 37±18 degrees (972 degrees)
Unfavorable anatomy
9 patients (56%)
Adverse morphology does
not meet IFU criteria of current FDA approved endografts
Neck length <9 mm 7 patients (44%)
Neck angulation >60 degrees 3 patients (19%)
CIA extending to hypogastric artery 3 patients (19%)
Procedural Results
16 patients
Procedural success 16/16 100%
Procedure time 56±22 (33-120 min)
Volume of polymer fill 72±31 (35-130ml)
Iliac extenders 4 (3 patients)
30 day Results
30 day mortality 0%
30 day morbidity 0%
Secondary procedures 0%
Significant adverse events 0%
Follow up evaluation
Follow up time 8±4 months (3-15 mo)
One
major adverse clinical event
Death from MI at 10 months 6 months CT OK
Overall mortality 1/16 6.3%
AAA related mortality 0%
No secondary treatments
No AAA or device related adverse events
Follow up imaging
Follow up CT scans
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-
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6 months 9/16 (100% of expected)
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-
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12 month 2/15 (100% of expected)
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One patient had a small amount of contrast visible between the endobag and AAA sac at 30 days which was not present at 60
days and 6 months
Follow-up CT imaging
9 patients at 6 month
AAA diameter no
change
5.93 ± 0.22 (baseline)
5.98
|
± 0.23 (1month) p=0.22
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5.94 ± 0.22 (6 months)
AAA volume no change
243 ± 29 cm2
(1 month) p=0.24
238 ± 27 cm2 (6 months)
No movement of lumen endoframes
No endoleaks
Summary
56% of patients had anatomy unsuitable for FDA approved endografts
100% procedural success
Complete aneurysm
exclusion, no endoleaks
Exclusion of common iliac aneurysms with preservation of internal iliac flow
Favorable early results
Discussion
Sac anchoring endoprostheses have the potential to overcome current EVAR limitations
Adverse neck anatomy / No neck
Elimination of persistent or new onset endoleaks
Simple treatment of iliac aneurysms without hypogastric occlusion
Improved long-term device stability
Preliminary
results are encouraging
Further studies with longer follow up are needed
Thank You
Pauls Stradins University Hospital
Riga, Latvia
In the Future, Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
VIVA CONTROVERSIES FORUM:
Treatment for Short Neck AAA Anatomy
In the
Future, Youre Both Wrong: Devices That Fill the Aneurysm Will Take Over
Andrew Holden, MD
Auckland City Hospital
Auckland, New Zealand
VIVA 10
In the Future, Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
Faculty Disclosure
Andrew Holden, MD
For the 12 months preceding
this CME activity, I disclose the following types of financial relationships:
Consulted for:
Research, clinical trial, or drug
Abbott Vascular Laboratories
Cook Medical Systems
Endologix Inc.
Flexible Solutions Ltd
Nellix Inc.
study funds received from:
Endologix Inc.
Flexible Solutions Ltd
Nellix Inc.
Medtronic
I will be discussing products that are
investigational or not labeled for use under discussion.
Andrew Holden. MD
VIVA 10
In the Future, Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
Short Neck AAA: The Challenge
Current EVAR devices can only treat ~60% of infra-renal AAA anatomies because they require a length of proximal neck for seal +/- fixation
Andrew Holden. MD
VIVA 10
In the Future, Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
Short Neck AAA: The Challenge
Fenestrated and branch grafts can treat short necked AAAs, avoiding the early morbidity of open repair.
Challenges include:
Device availability
Operator experience
Procedural complexity
Branch vessel loss
Martin M et al Ann Vasc Surg. 2010:24:106-112.
Nordon IM et al. Eur J Vasc Endovasc Surg. 2009:38:35-41.
Andrew Holden. MD
VIVA 10
In the Future, Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
Short Neck AAA: The Challenge
A device that fills the aneurysm sac rather than relies on graft-wall apposition for sealing has the potential to treat almost all infra-renal AAA anatomies.
Andrew Holden, MD
VIVA 10
In the Future, Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
Nellix Endovascular System
A radically different endovascular system for AAA repair
Major components:
Endoframes: maintain a flow
lumen to each leg
Endobags: filled with a polymer that quickly sets to fill the aneurysm sac around the
endoframes
Risk of aneurysm rupture is prevented
Andrew Holden, MD
VIVA 10
In the Future, Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
Nellix Endovascular System
Devices introduced
Endoframes deployed
Andrew Holden, MD
VIVA 10
In the Future, Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
Nellix Endovascular System
Endobags pre-filled
Endobag polymer fill
Andrew Holden, MD
VIVA 10
In the Future, Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
Nellix Endovascular System
5mm long neck
Andrew Holden, MD
VIVA 10
In the Future, Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
Nellix Endovascular System
Unful endobags
Position and deploy endoframes
Pre-fill endobags and check DSA
Andrew Holden, MD
VIVA 10
In the Future, Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
Nellix Endovascular System
Fill endobags with polymer and cure
Check
angiogram
Post-dilate endoframes
Andrew Holden, MD
VIVA 10
In the Future Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
Nellix Endovascular System
Completion angiogram
30-day CT
30-day CT
Andrew Holden, MD
VIVA 10
In the Future Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
Post-Procedural Imaging
Pre-contrast
Post-contrast
Thrombus, endobags (arrows) and endoframes easily seen
Andrew Holden, MD
VIVA 10
In the Future Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
Nellix Endovascular System
Major advantages of the system:
Because the
endobags are sealing the aneurysm, most anatomies (including short necks) can be treated
Because the blood
volume in the aneurysm sac is filled by the endobags, endoleaks are highly unlikely
If endoleaks and migration
are rare, post-procedural surveillance may be significantly reduced
Andrew Holden, MD
VIVA 10
In the Future Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
Short Neck AAA
Short proximal neck with posterior bulge
Andrew Holden, MD
VIVA 10
In the Future Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
Short Neck AAA
Short proximal neck with posterior bulge
Unsubtracted
Subtracted
Andrew Holden, MD
VIVA 10
In the Future Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
Short Neck AAA
Short proximal neck with posterior bulge
Lateral Projection
X ray @ 30 days
Andrew Holden, MD
VIVA 10
In the Future Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
Short Neck AAA
Short proximal neck with posterior bulge
Pre-procedural CT
Post-procedural CT
Andrew Holden, MD
VIVA 10
In the Future Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
First 34 Patients
Riga, Latvia (D Krievins) 16 patients
Auckland,
NZ (A Holden, A Hill) 12 patients
Aortic neck length: 22.1 mm (5.0 50 mm)
Technical success: 100%
Rupture: 0%
Conversion to open repair: 0%
Secondary interventions: 2.9%
Proximal Type 1 endoleak @ 6/12 months: 0%
Type 2
endoleak @ 6/12 months: 0%
34 subjects @ 1 month, 20 subjects @ 6 months, 10 subjects @ 12 months
Andrew Holden, MD
VIVA 10
In the Future Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
Conclusions
The Nellix endovascular systems is a radically different approach to EVAR
Experience is limited but early results suggests short neck AAA can be successfully treated with this system
Type 2 and other endoleaks have not been seen to date
Andrew Holden, MD
VIVA 10
In the Future Youre Both Wrong Devices That Fill the Aneurysm Will Take Over
Celebrating 8 Years of Unsurpassed Education in Vascular Medicine and Intervention
VIVA 10
Endoluminal Aortic Aneurysm Repair Using a Novel Sac Anchoring Endoprosthesis:
Favorable vs. Adverse Anatomy
Frans Moll, Dainis Krievins, Andrew Holden, Janis Savlovskis, Carlos Calderas, Carlos Donayre, Barry Katzen and Christopher Zarins
The University of Utrecht, Utrecht, The Netherlands
and the Nellix Investigators
European Society for Vascular Surgery
Amsterdam,
NL
September 19, 2010
Disclosure
This study was supported by Nellix, Inc., Palo Alto, CA, USA
The device is produced by Nellix, Inc.
One or
more investigators have a financial interest in Nellix
Unresolved problems with EVAR
Endoleaks
Aneurysm enlargement and rupture
Migration
Long term positional stability
Unsuitable anatomy
Aortic neck
Iliac arteries
Novel Sac Anchoring Endoprosthesis
Dual balloon expandable endoframes provide flow lumens
Polymer filled endobags obliterate aneurysm sac, provide support and eliminate endoleak space
Fixation is not dependent on proximal neck and iliac arteries
Common iliac aneuryms are treated with preservation of internal iliac
Baseline CT
Post-Op CT
Purpose
Review results of prospective, multi-center, clinical trial
4 clinical sites: Latvia, New Zealand, Venezuela, Colombia
34 patients treated from 2008-2010
Follow up 15
± 6 months
Compare patients with favorable vs. adverse anatomy
Favorable anatomy = suitable for current endografts
Adverse anatomy = unsuitable for current endografts
Core Laboratory analysis of CT scans:
Baseline, 30 days, 6 months, 1 year, 2 years
Sac anchoring endoprosthesis
Favorable anatomy
Pre
Post
1 month CT scan
Adverse anatomy
neck length 11 mm, funnel neck, common iliac aneurysm
3.5 cm CIA.
Nellix iliac extender Internal iliac
flow preserved
Adverse anatomy
neck length 5 mm; neck angle 72 degrees; 28 mm common iliac aneurysm
lliac aneurysm Nellix extender Internal iliac patent
Patient population
Age: 71±8 years (range 53-84 years)
Gender: men 91%, women 9%
Comorbidities
CAD 56%
CHF 20%
Hypertension 68%
DM 12%
Smoking 50%
PVD 21%
Aortic aneurysm: 5.8 ± 0.8 cm
(4.2-7.6 cm)
Neck diameter 24 ± 3 mm(18-31 mm)
Neck length 21 ± 12 mm(5-50 mm)
Neck angle 37± 15 degrees (9-72 degrees)
Core lab measurements
Adverse anatomy
unsuitable for FDA approved devices
Patients with
adverse anatomy 17 50%
6 pts had two or more adverse measures
Patients with favorable anatomy 17 50%
Adverse anatomy measures
Neck length < 10 mm 8
24%
Neck angulation > 60 degrees 3 9%
Iliac aneurysm diameter > 23 mm 13 38%
Procedural Results
34 patients
Procedural success 34/34 100%
Procedure time 70 ± 32 min
Volume of polymer fill 73 ± 33 ml
Blood
loss 165 ± 107 ml
30 day mortality 1/34 2.9%
Multisystem organ failure
Non-device related (post-procedure CT and autopsy)
Endoleak 2/34 5.9%
Limited space endoleak on CT scan
Hypogastric
flow preserved in 10 of 11 common iliac aneurysms treated
Limited space endoleaks
Contrast in space between endobag and aneurysm wall on post-op CT scan 2 patients
Spontaneously resolved in 60 days
Endobag does
not cover bottom of aneurysm
Endoleak persists; no change in aneurysm size
Resolved with iliac extender at 15 months
30 days 1 year
Follow up evaluation
Follow up time 15 ± 6 months (7-27 mo)
All-cause mortality 2/34 5.9%
1 peri-operative death
1 late death at 10 months
due to CHF
Normal CT scan at 6 months
No surgical conversions
No ruptures
One secondary treatment
Endovascular treatment of persistent endoleak at 15 months
No new endoleaks
CT scan evaluation out to 2
years
No change in aneurysm size
Aneurysm diameter (based on the maximum and minimum diameter at the level of maximum sac crossectional area)
(mm)
60.0 40.0 20.0 0.0
Baseline CTA 1. month follow-up 6. month follow-up 1.year follow-up
Mean ± 95% CI.
Follow-up period
Pre-op 1month 6month 12months
24months
No change in device position
Vertebra-to-stent distance E and G (mm)
40.0 35.0
30.0 25.0 20.0 15.0 10.0
right e left g
N=33 N=30 N=19
1.month follow-up 6. month follow-up 1. year follow-up
Follow-up period
Mean ± 95% CI.
SMA to Top Endoframe Distance
1 mo: 16.6 ± 2.7 mm
6 mo: 18.4 ±
2.8 mm
12 mo: 17.4 ± 3.0 mm
Conclusions
Patients with both favorable and adverse anatomy can be successfully treated using this novel sac anchoring endoprosthesis
Complete fill of aneurysm sac eliminates the endoleak space
Common iliac aneurysms can be treated with preservation of internal iliac flow
Discussion
Sac anchoring endoprostheses have the potential to overcome current EVAR limitations
Adverse neck anatomy / No neck aneurysms
Common iliac aneurysms with patent hypogastric arteries
New and persisting endoleaks
Migration of
endograft
Early results are promising
Longer-term follow up is needed
COVER STORY
Fillable Endovascular
Aneurysm Repair
An early look at a next-generation EVAR technology that may address some current
limitations and improve clinical outcomes.
BY CARLOS DONAYRE, MD; GEORGE E. KOPCHOK, BS; AND RODNEY A. WHITE, MD
Approximately 19% of patients develop an endoleak or endotension within the first 18±8.2 months after endovascular repair (EVAR) of an abdominal aortic aneurysm (AAA) using current
commercially available stent graft technologies, which depend solely on proximal neck sealing and fixation. 1 The majority of endoleaks are type II in nature, 2 which may be addressed through minimally invasive, catheter-based techniques with
associated low complication rates. However, these secondary procedures are costly and involve patient surveillance with annual CT scans. 3 Furthermore, in a small percentage of these EVAR cases, which develop persistent endoleaks or endotension and
continued aneurysm sac enlargement, a surgical conversion is required to prevent aneurysm rupture. 2 In addition, currently available commercial EVAR devices fit only 39.3% to 66%4,5 of otherwise eligible patients due to the anatomical restrictions
specified in their labeling. Finally, these first-generation stent grafts have a limited durability and life expectancy, which is less than that of surgical grafts.4,6,7
Presently available commercial endografts all share similar design and materials and are primarily based on bifurcated configurations. The first commercial endografts (Ancure, Guidant
Corporation, Indianapolis, IN) were composed of a tube graft design with hooks at the proximal end to attach the graft to the native aorta. Reliance on proximal fixation was enhanced by adding expandable wire stents, and bifurcated systems were
designed to achieve fixation in the iliac arteries. Later, stents were incorporated along the full length of the graft to create supported stent grafts, and the aortic graft bodies were lengthened to reduce the reliance on the proximal stent for
sealing (AneuRx, Medtronic, Minneapolis, MN; and Powerlink, Endologix, Inc., Irvine, CA). In addition, hooks,
... EVAR is currently limited to the treatment of AAAs with specific anatomical characteristics.
barbs, and stents designed with increased radial force have been implemented to decrease migration, minimize endoleaks,
and prevent failures (Zenith, Cook Medical, Bloomington, IN; Excluder, W.L. Gore & Associates, Flagstaff, AZ; and Talent, Medtronic). In order to address the varied aortic and iliac anatomic morphology, manufacturers developed modular stent
graft component systems composed of various aortic and iliac components. These multipiece stent graft systems introduced a new failure mode classified as a type III endoleak: modular device separation as the device junctions were subjected to
constant pulsation of blood flow through the graft. Furthermore, deployment of device extenders adds time, blood loss, and cost to the overall EVAR procedure.
Based on the above considerations, EVAR is currently limited to the treatment of AAAs with specific anatomical characteristics. Fenestrated and branched endografts have been introduced to
shift the proximal sealing zone from the infrarenal to the suprarenal aorta, thus expanding EVAR treatment to juxta-, para-, and suprarenal aneurysms. However, fenestrated endografts require experienced operators, custom devices, and lengthy
procedural times.8,9
THE NELLIX FILLABLE EVAR TECHNOLOGY
To expand the applicability of EVAR and address the failure modes observed with current endografts, Nellix
64 | ENDOVASCULAR TODAY | JANUARY 2009
COVER STORY
Endovascular (Palo Alto, CA) has designed a fillable, sac-anchoring, low-profile endovascular device. The Nellix technology encompasses a fully contained, polymer-filled endobag, which
conforms perioperatively to the specific shape of the patients aneurysm while providing anchoring and sealing. The polymer is contained inside an expanded polytetrafluoroethylene (ePTFE) bag that is lined on the inside by a metallic endoframe
that forms the endoskeleton for the new lumen inside the aneurysm. The polymer itself is a proprietary formulation based on polyethylene glycol (PEC), which is biostable. PEG-based material chemistries have been approved for use in devices for
vascular closure, cranial, and abdominal applications. Structural integrity of this composite device has been established through long-term in vitro and in vivo studies.
This fillable EVAR system is designed to provide aneurysm exclusion and long-term device stability, offering an exponentially larger sealing surface area compared to conventional stent
grafts, as well as to possibly minimize remodeling of the aneurysm sac by eliminating lateral movement. The Nellix technology essentially freezes the diseased aortic sac and landing zones by filling the open spaces and gaps around the
implant. The premise of this concept is that a reduction or elimination of remodeling may have a positive impact on long-term durability and reduction of endoleaks. Long-term remodeling of the aorta will be followed over time in a well-controlled
clinical trial. In addition, this unique design may also eliminate migration of the endograft due to complete filling of the aneurysm sac.
POTENTIAL BENEFITS Ability to Treat More Patients
The Nellix Fillable Sac Anchoring Prosthesis is designed to treat all infrarenal AAAs and aortoiliac aneurysms, including
an expanded patient population with adverse neck anatomies (infrarenal neck lengths <1 cm and neck angulations >60°).
Durability
The Nellix device fills the aneurysm
with a polymer using a dual endobag containment system. By filling the entire aneurysmal sac, the endobags are designed to provide complete sealing of the aneurysm at all tissue surfaces, while providing structural integrity that would prevent
Pre: Treatment Post: 3 Month
Figure 1. Angiographic and CT images of an ovine patch aneurysm treated with the Nellix fillable EVAR device pre- and postimplantation.
Figure 2. Fillable EVAR device preserving hypogastric flow.
JANUARY 2009 | ENDOVASCULAR TODAY | 65
COVER STORY
long-term endoleaks caused by aneurysm remodeling and separation of modular components.
Minimizing Migration and Lateral Movement
Successful EVAR treatment by current stent graft devices is typically marked by AAA sac shrinkage. Aortic aneurysm
shrinkage has been shown to increase the bio-mechanical forces on the proximal attachment zone over time.10 This aneurysmal remodeling process may dislodge the graft from the proximal infrarenal aortic neck, resulting in a type I endoleak or
component separation resulting in a type III endoleak. Lateral movement of the endo-graft within an aneurysm sac may also be a predictor for stent graft instability and adverse events.10 In addition to potentially providing sealing in a no-neck,
highly angulated aneurysm, the Nellix system is intended to completely fill the aneurysm, thereby minimizing any lateral movement or migration of the implanted device.
PRECLINICAL STUDIES
The Nellix AAA endovascular
system has been deployed in animal models to evaluate aneurysm exclusions. Dacron patch aneurysms were created surgically in an ovine model and subsequently treated using the Nellix AAA system. Study results showed safety of the Nellix device in
terms of acute delivery, deployment, and aneurysm exclusion. Chronic studies, based on CT follow-up, also showed that effective long-term exclusion of AAAs with the Nellix prosthesis is feasible. Angiographic and CT images before treatment and at
3-month follow-up show patent lumens and aneurysm exclusion as evidenced by the absence of blood flow to the lumbar arteries (Figure 1). Histological examination demonstrated that implantation of the Nellix AAA endoprosthesis is associated with
minimal trauma and low inflammation.
The in vivo (Dacron) patch-aneurysm studies also provided early clinical
insights regarding the Nellix AAA device. Ovine models developed some mural thrombus inside patch aneurysms prior to treatment that could be identified by CT scans, similar to human AAAs. After the aneurysm was excluded, thrombus was trapped inside
the Dacron patch; no sac regression was seen. Remodeling in humans, in terms of thrombus and sac regression, however, is expected to be different and will be studied in a clinical trial through periodic CT scans at follow-up. Another significant
finding from the animal studies has been the total elimination of type II endoleaks, both acute and chronic, due to polymer filling and occlusion of side branch vessels (lumbars) feeding the aneurysm. Such reduction or elimination of endoleaks may
reduce the need for chronic surveillance of patients treated by the Nellix fillable EVAR technology.
CONCLUSION
As we look to the future, we can conceive of a low-profile, fillable, sac-anchoring AAA device that can address anatomical restrictions and long-term durability limitations of current EVAR
endografts. By filling the aneurysm space, this platform may also reduce the occurrence of acute and chronic endoleaks. Furthermore, the fillable EVAR platform might be able to be extended to treat thoracic aneurysms and concomitant iliac aneurysms
in a simplified fashion while preserving hypogastric flow as illustrated in Figure 2. As always, we must proceed with cautious optimism as new ideas invite new challenges and potential failure modes.
Carlos Donayre, MD, is a vascular surgeon at the Department of Surgery, Division of Vascular Surgery, Harbor-UCLA Medical
Center in Torrance, California. He has disclosed that he is a clinical advisor for Nellix, Inc., and receives research funding. Dr. Donayre may be reached at (310) 213-4878; cdonayre@cox.net.
George E. Kopchok, BS, is a biomedical engineer with Los Angeles Biomedical Research Institute, Harbor-UCLA Medical Center
in Torrance, California. He has disclosed that he is a paid consultant to and receives grant/research funding from Nellix, Inc. Mr. Kopchok may be reached at (310) 222-3854; gkopchok@labiomed.org.
Rodney White, MD, is Vascular Surgery Division Chief, Vascular Surgery Fellowship Program Director and Vice Chairman of
Research, Harbor-UCLA Medical Center, and Professor of Surgery, David Geffen School of Medicine at UCLA in Torrance, California. He has disclosed that he is a paid consultant to and receives grant/research funding from Nellix, Inc. Dr. White may be
reached at rawhite@ucla.edu.
1 Leurs LJ, Buth J. Laheij RJ. et al Long-term results of endovascular abdominal
aortic aneurysm treatment with the first generation of commercially available stent grafts Arch Surg 2007.142 33-41
2 Becquemin JP, Kelley L, Zubtlewicz T et al. Outcomes of secondary interventions after abdominal aortic aneurysm endovascular repair J Vasc Surg 2004,39 298-305
3 Brewster DC, Jones JE, Chung TK, et al Long-term outcomes after endovascular abdominal aorlic aneurysm repair-the first
decade Aon Surg 2006.244426-438
4 Carpenter JR Baum RA, Barker CF, et al Impact of exclusion criteria on
patient selection for endovascular abdominal aortic aneurysm repair J of Vase Surg 2001:34:1050-1054.
5
Cotroneo AR lezzi R. Giancristofaro D, et al. Endovascular abdominal aortic aneurysm repair how many patients are eligible for endovascular repair Radiol Med 2006:111: 597-606
6 Holzenbein TJ, Kreischmer G Thurnher S, et al Midterm durability of abdominal aortic aneurysm endogralf repair a word of
caution J Vasc Surg 2001.33:S46-54
7 Lifeline Registry of EVAR Publications Committee Lifeline registry of
endovascular aneurysm repair long-term primary outcome measures. J Vasc Surg 2005.42:1-10
8 0Neil S,
Greenberg RK Haddao F. et al Prospective analysis of fenestrated endovascular grafting intermediate-term outcomes Eur J Vasc Endovasc Surg 2006:44:115-123
9 Muhs BE. Verhoeven EL, Zeebregts CJ. et al Mid-term results of endovascular aneurysm repair with branch and fenestrated endografts J Vasc Surg 2006:44:9-15
10 Rafsi BY Abilez OJ, Benharash P et al Lateral movement of endografts within the aneurysm sac is an indicator of
stent-graft instability J Endovasc Ther 2008:15:335-343
66 | ENDOVASCULAR TODAY | JANUARY 2009
COVER STORY
The Frontier of New EVAR Device Technology
Andrew
Holden, MBChB, FRANZCR, provides his unique perspective on EVAR and a look at his latest trial experiences with new technology.
Endovascular Today: How is your perspective as a New Zealand practitioner particularly unique regarding the current treatment of aneurysms?
Dr. Holden: Australian and New Zealand interventionists were early innovators of endovascular aneurysm repair (EVAR)
technology. I was fortunate to be involved in my first EVAR case in 1994, and during the following 15 years, there has been tremendous development in endovascular technology. Based on our experience of very low periprocedural morbidity and mortality
associated with EVAR procedures, we evaluate all infrarenal abdominal aortic aneurysms (AAAs) for possible endoluminal repair. We also have extensive and positive experience with advanced techniques to treat thoracoabdominal aneurysms, such as
fenestrated and branch grafts and debranching procedures.
Endovascular Today: How would you describe the
regulatory and reimbursement environments for EVAR in New Zealand?
Dr. Holden: The regulatory environment in
New Zealand facilitates early access to new technologies. Although national and regional ethics committees rigorously evaluate research proposals for patient safety and informed consent, generally, there is a supportive environment working toward
thorough scientific evaluation and introduction of promising new technologies. This regulatory approach, combined with high-quality, state-funded tertiary hospitals attached to internationally recognized universities, provides an ideal environment
for the evaluation of new technologies such as advanced EVAR systems.
Endovascular Today: What are the
strengths and weaknesses of the current EVAR systems?
Dr. Holden: Current EVAR devices can achieve immediate
exclusion in up to 60% of infrarenal AAAs. However, the vast majority of modern devices require proximal and distal attachment site sealing to successfully exclude the aneurysm. Challenging proximal neck anatomy (ie, short, angulated, conical, or
diseased neck) is the most common contraindication to treatment with routine EVAR devices; however, challenging distal attachment site anatomy (ie, iliac artery dilatation or tortuosity) may also exclude an EVAR approach.
The durability of current EVAR devices is also a concern, with most published trials reporting significant reintervention
rates for complications such as endoleak and limb kinking. The cost of reintervention and rigorous postprocedural surveillance means that EVAR with current technology is less cost effective than open surgical repair.
Endovascular Today: As one of the early trialists using the Nellix fillable EVAR technology (Nellix Endovascular, Palo
Alto, CA), what can you tell us about the trials design and goals?
Dr. Holden: At Auckland Hospital, we
have been participating in a multicenter, prospective, single-arm, nonrandomized trial evaluating the Nellix EVAR technology. A comparative control arm is derived from patient data drawn from the AAA open-surgical control arms of four
JANUARY 2010 | ENDOVASCULAR TODAY | 1
COVER STORY
commercially approved EVAR devices. This data was obtained from the Society for Vascular Surgery.
Patients in the trial are screened to meet a predetermined set of inclusion and exclusion criteria. The primary goals of the study are to determine the technical success of the device, the
ability to deliver and place the device in the desired target area, freedom from the need for additional intervention, and freedom from enlargement of the aneurysm sac.
Endovascular Today: With the goal of the Nellix system to anchor the graft by filling the aneurysm with a polymer, have you seen an improvement in fixation?
Dr. Holden: Although long-term data is limited (five patients at 1 year and 16 patients at 6 months), the preliminary
observations of the Nellix system have shown no device migration. Because the majority of the blood volume within the aneurysm sac is occupied by polymer-filled endobags with his technology, fixation should not conceptually be a problem, and our
early observations are consistent with this.
Endovascular Today: Have you seen any evidence that suggests that
Nellix could offer EVAR treatment to patients with difficult anatomy (ie, small or angled necks, limited landing zones)?
Dr. Holden: Early fixation results have been encouraging. The major appeal of the Nellix system is its potential to seal infrarenal AAAs with challenging neck and iliac anatomies. This is
because sealing with this device is not achieved by graft-wall apposition (as with current EVAR device technologies), but via the polymer-filled endobags. Our experience is limited, but short and angulated infrarenal necks, as well as dilated iliac
arteries, have been successfully treated with the endobags conforming to underlying anatomy, including neck geometry. To date, 100% aneurysm exclusion has been achieved with no endoleaks.
Endovascular Today: Although filling the aneurysm could theoretically improve stability and promote fixation, foreign
matter is left permanently in the vessel. Do you have any concerns about how this may affect long-term outcomes?
Dr. Holden: The Nellix EVAR technology involves a cured, biocompatible polymer inside enclosed endobags. The outcomes,
based on successful preclinical studies (including long-term animal studies), have demonstrated excellent polymer-filled endobag durability. The clinical results to date have supported these findings.
Endovascular Today: One of the clinical endpoints monitored after an EVAR procedure has been regression or remodeling of
the aneurysmal sac. If, by its natural course, the aneurysmal sac did shrink or change shape after use of the Nellix system, is there any indication of how the polymer will react within the vessel, or the vessels reaction to the prevention of
movement?
Dr. Holden: It is too early to adequately answer this question. However, it should be pointed out
that the degree of aneurysm shrinkage occurring with the Nellix system is less than that with standard EVAR devices, because much of the original blood volume within the aneurysm sac is occupied by endobags. Absence of sac enlargement is likely to
be the most important end-point after EVAR with the Nellix system, rather than aneurysm shrinkage. That being said, our early experience has indicated that there is resorption of mural thrombus after EVAR with the Nellix system, and the degree of
overall aneurysm shrinkage is likely to depend on the volume of mural thrombus within the pretreatment aneurysm sac. It may be that the endobags surrounding the endoframes prevent major morphological changes after sac shrinkage, but this is just a
postulate at this stage.
Endovascular Today: What are some of the other technologies you have been studying,
or trials in which you have recently participated?
Dr. Holden: We have been involved in a number of
EVAR-related studies, including strategies to prevent rather than treat type II endoleaks, the development of magnetic resonance-visible EVAR devices, and the evaluation of branch graft technologies. Other recent peripheral arterial studies have
included first-in-man studies evaluating lower limb arterial stents, closure devices, and hemodialysis access devices. We have also been major contributors to the ICSS (carotid stent versus endarterectomy) and CORAL (renal stent versus medical
therapy) trials.
Andrew Holden, MBChB, FRANZCR, is Director and Associate Professor of Interventional
Radiology at Auckland Hospital and Auckland University School of Medicine in Auckland, New Zealand. He has disclosed that he holds no financial interest in any product or manufacturer mentioned herein. Dr. Holden may be reached at +64 21575227;
andrewh@adhb.govt.nz.
2 | ENDOVASCULAR TODAY | JANUARY 2010
The Nellix Procedure Animation is a 39 second animation with no audio that briefly demonstrates the process
of advancing the Nellix system into the aorta over two guidewires, expanding the endoframes via balloon dilation, then filling the endobags to completely fill the space within the aneurysm sac. This is a brief demonstration of the product and
procedure only, and does not illustrate every step in the proposed instructions for use.
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