Physician-slide-deck

Report
Aptus Heli-FX Overview
Physician Slide Deck
Developed by Aptus Endosystems, Inc.
MMA02281401
EVAR 1 Trial Shows Higher 2nd Interventions in EVAR
One of most important recent papers to date on long term
outcomes of EVAR: authors conclude:
EVAR has significantly more complications and secondary
interventions than open repair, and this worsens over time
Despite 2nd interventions, EVAR
experienced late ruptures. None with
surgery
Endoleaks w/sac expansion, migration,
kinking are strong predictors for rupture
EVAR is significantly more expensive overall
Due to associated long term follow-up and secondary interventions
Open Surgery
EVAR
$ 18, 586
$ 23,153
Greenhalgh RM et al. N Engl J Med 2010 May 20;362(20):1863-71
2
‘DREAM’ Study on LT Outcomes Support EVAR 1
The DREAM Study evaluated LT survival of Open vs. EVAR
Aneurysm Repair in The Netherlands
1.In EVAR group, significantly more 2nd interventions to
prevent ruptures (p=0.03)
• Surgical 2nd interventions primarily incision hernia
(not life critical)
• EVAR 2nd interventions primarily endoleak and
migration (life critical)
2.Trend of 2nd interventions in EVAR worsens over time
“ The cluster of re-interventions that appear in the fifth year
after endovascular repair is particularly troubling and casts
doubt on the durability of endovascular devices.”
De Bruin et al. N Engl J Med 2010;362:1881-9
3
ACE Trial Confirms EVAR Late Durability Limitations
The ACE Trial evaluated mid/long term outcomes of
EVAR vs. Open Surgical (OSR) patients (n=299) in
France
EVAR 2nd Interventions = 16%
Open surgery = 2.4% at median f/u of 3 years
The EVAR group had significantly more 2nd
interventions, and open surgery remains a ‘more
durable option’
Death free survival or freedom from 2nd intervention
Becquemin JP et al. J Vasc Surg 2011;53(5):1163-73.
4
Achilles Heel of EVAR Remains Late Failure
•
19.9% of pts require an average of 1.9 secondary
interventions within 5 years of EVAR1
•
Patients requiring any EVAR-related re-intervention
have 8.6-fold higher post-placement costs than those
not requiring re-intervention ($31,696 vs. $3,668,
p<0.05)
-
19.9% of patients account for 92.5% of post-placement
costs1
•
EVAR in difficult anatomy increases the need for secondary
intervention2,3
•
37.3% of interventions are associated with endograftrelated endoleaks and/or migration
- Costs average $8,722 – $21,382 to address endograft-related
endoleak or migration1
 EndoAnchor fixation may provide a definitive
improvement, notably in challenging anatomy
1. Noll et al. JVS 2007;46(1):9-15.
2. Abbruzzese et al. JVS 2008;48(1):19-28.
3. Houbballah et al. JVS 2010;52(4):878-83
5
Proximal Seal Stability Remains Key
•
Rates of 2nd interventions in EVAR are high and not improving
adequately
•
•
Complicated anatomy results in more Type I endoleaks &
higher re-intervention risk
•
•
•
•
Average re-intervention rate of 3.7%/yr from recent registry data1 IDE
trial data demonstrate average rate of 4.1%/yr2
Short neck length (<15mm)3,4
Neck angulation (>40º)5
More complicated patients are being treated as EVAR devices improve
There is acceptance that current standard follow-up imaging…
•
•
•
Carries risk (radiation, contrast media)1,6
Is expensive1,6
Confers suboptimal benefit (<10% of re-interventions are triggered by
routine follow-up imaging findings)6
Re-intervention-free survival1
1 yr
89.9%
2 yr
86.9%
5 yr
81.5%
Increased odds of type I endoleak and
need for re-intervention
Risk Factor
OR (95% CI)
2.2 (1.4-3.5)3,†
Neck Length < 15 mm
4.3 (2.1-8.7)4,‡
Neck angulation > 40°
 No other solutions exist for ‘radial fixation’ to
break the cycle of this dilating disease
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6.2 (2.9-13)4,†
1.
2.
3.
4.
5.
6.
5.9 (1.3-27.6)5,*
Nordon IM et al. Eur J Vasc Endovasc Surg 2010;39(5):547-54
Lifeline Registry data report. J Vasc Surg 2005;42(1):1-10
Leurs LJ et al. J Endovasc Ther 2006;13(5):640-8
Aburahma AF et al. J Vasc Surg 2009;50(4):738-48
Sternbergh WC et al. J Vasc Surg 2002;35(3):482-6
Dias NV et al. Eur J Vasc Endovasc Surg 2009;37(4):425-30
Hostile Necks Continue to Challenge Durability
Meta-Analysis of 7 major studies in EVAR by Antoniou et al1
comparing outcomes in hostile vs. friendly neck anatomies
Study
Sample Size
Major Grafts
Torsello et al, 2011
177
Endurant
AbuRahma et al, 2010
238
AneuRx, Excluder, Zenith, Talent
Hoshina et al, 2010
129
Excluder, Zenith
Abbruzzese et al, 2008
565
AneuRx, Excluder, Zenith
Choke et al, 2006
147
Talent, Zenith, Excluder, AneuRx
Fulton et al, 2006
84
AneuRx
Fairman et al, 2004
219
Talent
Total sample size: N=1559 patients
1Antoniou
GA et al. J Vasc Surg. 2013;57(2):527-38.
7
Hostile Necks Continue to Challenge Durability
Major findings:
• Adjunctive procedures more frequent in challenging proximal necks
• Type I endoleaks 4.5x more likely at 1-year after endograft
implantation in hostile proximal aortic neck anatomy (P = .010)
• Aneurysm-related mortality risk 9x greater in hostile neck anatomy
(P= .013)
Antoniou GA et al. J Vasc Surg. 2013;57(2):527-38.
8
Neck Dilatation: A Cause for 2nd Intervention
Multiple recent studies confirm neck dilatation
in EVAR remains REAL
Author
FollowUp
Grafts studied
Proximal Neck
Dilatation Rate
Outcomes in dilated
necks
Oberhuber
et al.1
39 mos
average
Zenith (N=29), Talent
(N=35), Excluder (N=39)
22%
31% re-interventions
Pintoux et
al.2
57 mos
average
Talent (N=33), Aneurx
(N=25)
24%
Bastos
Gonçalves
et al.3
5 yrs
median
Excluder (N=144)
37% overall,
66% in pts >7 yrs f/u
1Oberhuber
2Pintoux
3Bastos
(defined as >2mm diam
increase)
(defined as >3mm diam
increase)
(defined as >2mm diam
increase)
A et al. J Vasc Surg 2012 April;55(4): 929-34
D et al. Ann Vasc Surg. 2011 Nov;25(8):1012-9
Goncalves F et al. J Vasc Surg. 2012 Oct;56(4):920-8
9
5% late type Ia
endoleak
16% migration
Increased odds of
migration (≥5mm)
5.5x
Strategies for Treating Type I Endoleaks
Current solutions do not offer consistent effectiveness
Palmaz
effectiveness
is limited
• Byrne et al reported:
• Persistent type Ia endoleak in 8.6% (14/162) pts at the end of primary
procedure1
• Can preclude future re-interventions, e.g. FEVAR, EndoAnchors
Mixed results
with Cuffs
• Jim J et al. reported:
• 12% (18/151) re-developed Type I/III Endoleaks at 43 mos average f/u
post Zenith Renu placement2
Limitations
with Coils and
Onyx
• Require precise ID of leak paths: non-target embolization risk3
• Time consuming4
• Onyx could create CT artifacts precluding identification of endoleaks in
F/U4
•
None of these resist further neck dilatation
•
Frequently multiple devices needed, adding time & cost
•
Palmaz, coils, Onyx not indicated for Tx of Type I Endoleak
1Byrne
J et al. Ann Vasc Surg. 2013 May;27(4):401-11.
J et al. J Vasc Surg. 2011 Aug;54(2):307-315.
3Peynircioğlu B et al. Diagn Interv Radiol. 2008 Jun;14(2):111-5.
4Chun JY et al. Eur J Vasc Endovasc Surg. 2013 Feb;45(2):141-4.
2Jim
10
The Concept of EndoAnchors
BRINGING THE STABILITY OF SURGICAL ANASTOMOSIS TO EVAR
Surgical Anastomosis
EndoAnchoring
Case images courtesy of John Aruny MD, Bart Edward
Muhs, MD, PhD and and Burkhart Zipfel, MD.
11
Long-Term Vision of EndoAnchors in EVAR
Mitigate
reinterventions,
Prevent late
term seal
complications in
primary setting
Treat seal
expand
complications &
prevent
recurrence in
revision setting
candidates for
EVAR
Replicate surgical
anastomosis, arrest neck
dilatation
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Reduce
follow-up
by preventing
type I leaks and
sac growth
Published Initial Experiences with EndoAnchors
Feasibility in
replicating surgical
anastomosis and arresting
neck dilatation
Experience in
Primary EVAR
Experience in
EVAR Revision
TEVAR experience
• Melas et al J Vasc Surg. 2012;55(6):1726-1733
• Gomero-Cure et al J Vasc Surg. 2012;55:1S
• Perdikides et al J Endovasc Ther. 2012;19.
• Hogendoorn W et al. Ann Vasc Surg 2013; doi:
10.1016/j.avsg.2013.07.028
• Avci et al J Cardiovasc Surg. 2012; 53:419-26.
• de Vries et al J Vasc Surg. 2011;54:1792-1794.
• Kasprzak et al. J Endovasc Ther. 2013 Aug;20(4).
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Indications for Use (FDA and CE Mark)
•
The Heli-FX EndoAnchor System is intended to provide fixation and augment sealing
between endovascular aortic grafts and the aorta
•
The Heli-FX EndoAnchor System is indicated for use in patients whose endovascular
grafts have exhibited migration or endoleak, or are at risk of such complications
•
The Aptus EndoAnchor and Heli-FX have been evaluated and determined to be
compatible with the following endografts:
Medtronic Endurant®
Gore Excluder®
Cook Zenith®
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Medtronic Talent®
Medtronic AneuRx®
Heli-FX™ for Managing Late Seal Complications
 No late Type 1 endoleak in 4-5 year f/u
– STAPLE-1 & 2 IDE study
 High success in treating late Type I
Endoleaks
– >90% success in revision cases per
ANCHOR registry1
 Demonstrated safety in >2,000 pts
treated
No damage post 400M cycles,
equivalent to 10 years in vivo
– In >10,000 implanted EndoAnchors to-date,
no reported late Anchor Dislocations,
Fractures, Graft Damage or Fistula2
– 400MM cycles fatigue testing2
1Based
on article:
ANCHOR registry demonstrates safety and technical success of utilizing
endoanchors in primary and revision EVAR Vascular News 11 Oct 2013
Images courtesy of Aptus Endosystems, Inc.
15
2Based
on commercial and study on file at Aptus
ANCHOR Registry capturing real-world usage
Europe: Dr. Jean-Paul de Vries – Chief of Vascular Surgery, St. Antonius
Registry Principal
Investigators
Hospital
US: Dr. William Jordan – Chief of Vascular Surgery/Endovascular Therapy,
Univ. of Alabama
Registry Design
Prospective, observational, international, multi-center, dual-arm
Registry
“Primary” – Up to 1000 pts, Prophylactic
Treatment Arms
“Revision” – Up to 1000 pts, Therapeutic
Duration
5 Years
Follow-up
Per Standard of Care at each center & discretion of Investigator
Over 350 Patients enrolled as of Feb 2014
16
Heli-FX System: Applier + Guide + 10 EndoAnchors
3 mm
Cross Bar
1.0 mm
3.5 mm
Images courtesy of Aptus Endosystems, Inc.
17
Aptus Heli-FX Product Offerings
Aptus™ Heli-FX™ Thoracic
EndoAnchor ™System
18Fr OD,
90cm working length
Aptus™ Heli-FX™
EndoAnchor™ System
16Fr OD,
62cm working length
Images courtesy of National Institute of Health and Aptus Endosystems, Inc.
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EndoAnchor Deployment Animation
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EndoAnchors: Which Patients Can Benefit?
PROPHYLAXIS
TREATMENT
Hostile Anatomy
Normal Anatomy
Overcoming concerns for
implant stability
Mitigating risk of reinterventions
Challenging neck
anatomies
Severe
comorbidities that
preclude safe reintervention
(e.g. wide, short,
conical, angulated)
Difficult landing
(e.g. birdbeaking,
close to branched
vessels)
Patients potentially
lost during F/U
Long remaining life
expectancy (young
pts)
20
Resolve proximal seal
failures
Acute type I endoleaks
during primary
procedure
Late-term type I
endoleaks
Augmenting stability in
migrated grafts
Case Example – EndoAnchors in Primary EVAR
•
•
•
Short, reverse taper proximal neck
Intraoperative Type I post-implantation of Cook Zenith
6 EndoAnchors implanted - Type I endoleak resolved
Image s from article: Gandi RT and Katzen BT, Treating a Type Ia
Endoleak Using EndoAnchors, Endovascular Today, March 2012
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Case Example – EndoAnchors in EVAR Revision
•
•
3 year F/U showed migrated Talent with type Ia endoleak
Endurant cuff and EndoAnchors implanted - endoleak resolved
Images from article: de Vries JP et al, Use of Endostaples to Secure
Migrated Endografts and Proximal Cuffs after Failed Endovascular
Abdominal Aortic Aneurysm Repair, J Vasc Surg 2011; 54:1792-4.
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Conclusions
• Major EVAR studies highlight late durability limitations
– e.g. ‘EVAR 1,’ ‘ACE,’ ‘DREAM’
– Proximal seal stability remains key
• EndoAnchors designed to bring long-term stability of
surgical anastomosis to EVAR
• High safety and efficacy
– Demonstrated safety profile
– High success in type I endoleak Tx per ANCHOR registry
– More definitive data for prevention in-process
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