transcript
- Slide 1
- Aptus Heli-FX Overview Physician Slide Deck Developed by Aptus
Endosystems, Inc. MMA05141501
- Slide 2
- R.M. Greenhalgh et al. N Engl J Med 2010, 10.1056/NEJM 0909305
De Bruin et al. N Engl J Med 2010;362:1881-9 Major Studies Show
Higher 2 nd Interventions in EVAR vs. Open Repair Late ruptures in
EVAR, none in open surgery Unlike open repair, endoleaks and
migration are major complications of EVAR Predictors for rupture,
and risks increase with time Open surgery remains a more durable
option In ACE, 16% re-interventions in EVAR vs. 2.4% for open
repair at 3 yr median f/u Becquemin JP et al. J Vasc Surg
2011;53(5):1163-73. DREAM EVAR-1 ACE 2
- Slide 3
- StudySample SizeEndografts Torsello et al, 2011177Endurant
AbuRahma et al, 2010238AneuRx, Excluder, Zenith, Talent Hoshina et
al, 2010129Excluder, Zenith Abbruzzese et al, 2008565AneuRx,
Excluder, Zenith Choke et al, 2006147Talent, Zenith, Excluder,
AneuRx Fulton et al, 200684AneuRx Fairman et al, 2004219Talent
Meta-Analysis of 7 major studies in EVAR by Antoniou et al 1
compared outcomes in hostile vs. friendly neck anatomies (total
patients N = 1559) 1 Antoniou GA et al. J Vasc Surg.
2013;57(2):527-38. 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) 3 Hostile Proximal Necks Further
Challenge EVAR
- Slide 4
- Another similar meta-analysis by Stather et al. of 16 major
studies confirms higher risks in hostile necks Further
substantiation that EVAR still faces significant challenges in
hostile proximal neck anatomy Stather PW et al. J Endovasc Ther.
2013;20:623637 Total sample size: N=11,959 patients Hostile
Proximal Necks Further Challenge EVAR 4
- Slide 5
- Neck hostility Intra-op adjunctive procedures Intra-op
endoleaks All cause mortality On label 9.9%0.5%1.1% 2 hostile neck
parameters 26.7%6.7%13.3% >2 hostile neck parameters 50%16.7%
Speziale et al. shows greater proximal seal complication risks as
the number of hostile neck parameters increases Speziale F et al,
Annals of Vascular Surgery (2014), doi: 10.1016/j.avsg.2014.06.057.
Greater than 1 hostile neck parameter substantially increases
mortality, major adverse events, intra-op endoleaks and adjunctive
procedures Influence of Multiple Hostile Neck Parameters 5
- Slide 6
- Which Proximal Necks are Hostile? Study by Jordan WD et al.
assesses proximal neck anatomic criteria that are most predictive
of success or failure after EVAR Evaluated N=221 patients from
ANCHOR post-market registry Failure defined as: Type Ia endoleak
upon endograft implantation Type Ia endoleak identified in post-op
follow-up* *In endografts without EndoAnchors Identified proximal
neck variables that independently predict type Ia endoleak: Neck
diameter 26 mmP =.002 Neck length 17 mmP =.017 Certain on-label
necks can be at-risk Jordan WD et al. J Vasc Surg. 2015 Feb 28.
pii: S0741-5214(15)00065-8. 6
- Slide 7
- AuthorFollow- Up Grafts studiedProximal Neck Dilatation Rate
Outcomes in dilated necks Oberhuber et al. 1 39 mos average Zenith
(N=29), Talent (N=35), Excluder (N=39) 22% (defined as >2mm diam
increase) 31% re-interventions Pintoux et al. 2 57 mos average
Talent (N=33), AneuRx (N=25) 24% (defined as >3mm diam increase)
5% late type Ia endoleak 16% migration Bastos Gonalves et al. 3 5
yrs median Excluder (N=144)37% overall, 66% in pts >7 yrs f/u
(defined as >2mm diam increase) Increased odds of migration
(5mm) 5.5x 1 Oberhuber A et al. J Vasc Surg 2012 April;55(4):
929-34 2 Pintoux D et al. Ann Vasc Surg. 2011 Nov;25(8):1012-9 3
Bastos Goncalves F et al. J Vasc Surg. 2012 Oct;56(4):920-8
Multiple recent studies confirm neck dilatation in EVAR remains
REAL Neck Dilatation: A Cause for 2 nd Intervention 7
- Slide 8
- 1.Nordon IM et al. Eur J Vasc Endovasc Surg 2010;39(5):547-54.
2.Dias NV et al. Eur J Vasc Endovasc Surg 2009;37(4):425-30.
Compromise of EVAR and Long-Term F/U 8
- Slide 9
- Image courtesy of National Institute of Health AAA
ClassificationPossible TI EL TX Options Infra-renalEVAR Revision*,
open surgical conversion, FEVAR conversion Juxta-renalOpen surgical
conversion, FEVAR conversion, CHIMPs Supra-renalOpen surgical
conversion, FEVAR conversion, CHIMPs TAA ClassificationPossible TI
EL TX Options AscendingOpen surgical conversion Aortic ArchTEVAR
Revision*, hybrid DescendingTEVAR Revision* *Ballooning, cuffs,
Palmaz, coils, Onyx and/or CHIMPs may be considered in EVAR/TEVAR
revision Type I Endoleak? What Have Been Our Options What do we do
when? Standard revision techniques cannot be used or dont seal
endoleak? Patients are unfit for FEVAR or open surgical conversion?
Image courtesy of National Institute of Health 9
- Slide 10
- EndoAnchoringSurgical Anastomosis Case images courtesy of John
Aruny MD, Bart Edward Muhs, MD, PhD. Tailored Seal and Fixation of
EndoAnchors CREATE THE STABILITY OF A SURGICAL ANASTOMOSIS IN EVAR
AND TEVAR Displacement force in Newtons Chart from data published
in Melas N, et al. J Vasc Surg 2012;55(6):1726-33 10
- Slide 11
- Replicate surgical anastomosis Prevent late term seal
complications in primary setting Treat seal complications &
prevent recurrence in revision setting Mitigate reinterventions in
EVAR Improve surveillance intervals by preventing type I leaks and
sac growth Long-Term Objectives of EndoAnchors in EVAR 11 Completed
In-process Next phase Legend: Status of clinical
substantiation
- Slide 12
- Intended to provide fixation and augment sealing between
endovascular aortic grafts and the aorta 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: Heli-FX Indications for Use (FDA and
CE Mark) 12 Cook Zenith Gore Excluder Medtronic AneuRx Medtronic
Endurant Medtronic Talent Jotec GmbH
- Slide 13
- TREATMENTPROPHYLAXIS Hostile Anatomy Overcoming concerns for
implant stability Challenging neck anatomies (e.g. wide, short,
conical, angulated) Difficult landing (e.g. birdbeaking, close to
branched vessels) Normal Anatomy Mitigating risk of re-
interventions Severe comorbidities that preclude safe re-
intervention Patients potentially lost during F/U Long remaining
life expectancy (young pts) Resolve proximal seal failures Targeted
sealing of acute type I endoleaks Targeted sealing of late type I
endoleaks Augmented stability in migrated grafts How to Manage EVAR
with EndoAnchors? Case image from Gandhi RT, Katzen BT Treating a
Type 1A Endoleak Using EndoAnchors. Endovascular Today March 2012
23:26. 13
- Slide 14
- Performance Verified equivalence to the strength of a surgical
anastomosis 1 Designed to provide radial support and resist neck
dilatation Safety In >4,000 cases and >23,000 EndoAnchors
implanted to- date, no confirmed graft damage or late anchor
fracture 3 No anchor dislocation after successful implantation in
aortic tissue 3 No unanticipated adverse device events in ANCHOR
registry (N=319) 2 Benefits Customizable placement to target
concerning anatomical areas and Type I endoleaks Steerable guide
for precise and accurate placement Motorized controls for two-stage
deployment with repositioning EndoAnchor Tailored Seal and Fixation
1 Melas N et al, J Vasc Surg 2012;55:1726-33 2 Jordan WD et al, J
Vasc Surg 2014 Jul 31. pii: S0741- 5214(14)00929-X. doi:
10.1016/j.jvs.2014.04.063 3 Based on data on file at Aptus as of
May 2015 No damage post 400M cycles, equivalent to 10 years in vivo
Images courtesy of Aptus Endosystems, Inc. 14
- Slide 15
- Cross Bar 3 mm 1.0 mm 3.5 mm Heli-FX System: Applier + Guide +
10 EndoAnchors Images courtesy of Aptus Endosystems, Inc. 15
- Slide 16
- Aptus Heli-FX Thoracic EndoAnchor System Aptus Heli-FX
EndoAnchor System 16Fr OD, 62cm working length 18Fr OD, 90cm
working length Aptus Heli-FX Product Offerings Images courtesy of
National Institute of Health and Aptus Endosystems, Inc. 16
- Slide 17
- EndoAnchor Deployment Animation 17
- Slide 18
- Over 570 Patients enrolled as of May 2015 Registry Principal
Investigators Europe: Dr. Jean-Paul de Vries Chief of Vascular
Surgery, St. Antonius Hospital US: Dr. William Jordan Chief of
Vascular Surgery/Endovascular Therapy, Univ. of Alabama Registry
Design Prospective, observational, international, multi-center,
dual-arm Registry Treatment Arms Primary Up to 1000 pts,
Prophylactic Revision Up to 1000 pts, Therapeutic Duration 5 Years
Follow-up Per Standard of Care at each center & discretion of
Investigator ANCHOR Registry Capturing Real-World Usage 18
- Slide 19
- ANCHOR in the Scientific Literature 19 5 papers published since
2014 Rationale of EndoAnchors in abdominal aortic aneurysms with
short or angulated necks De Vries JP et al. J Cardiovasc Surg
(Torino). 2014 Feb;55(1):103-7 Results of the ANCHOR prospective,
multicenter registry of EndoAnchors for type Ia endoleaks and
endograft migration in patients with challenging anatomy Jordan WD
et al. J Vasc Surg. 2014 Oct;60(4):885-92.e2. Analysis of
EndoAnchors for endovascular aneurysm repair by indications for use
de Vries JP et al. J Vasc Surg. 2014 Dec;60(6):1460-7.e1
Outcome-based anatomic criteria for defining the hostile aortic
neck Jordan WD et al. J Vasc Surg. 2015 Feb 28. pii: S0741-
5214(15)00065-8 Midterm Outcome of EndoAnchors for the Prevention
of Endoleak and Stent-Graft Migration in Patients With Challenging
Proximal Aortic Neck Anatomy Jordan WD et al. J Endovascular
Therapy 2015; 22(2):163170
- Slide 20
- 20 ANCHOR Shows High Prophylactic Use Indications for
EndoAnchoring in Revision n=99 Indications for EndoAnchoring in
Primary n=307 Jordan WD et al. J Vasc Surg. 2014;60:885-892
- Slide 21
- Complex AAA and complications have warranted EndoAnchor
tailored seal and fixation with ALL major endografts Jordan WD et
al. J Vasc Surg. 2014;60:885-892 ANCHOR Includes All Major
Endografts Confirms EndoAnchoring need is independent of endograft
design, dependent on anatomical challenges and post-implant disease
progression 21
- Slide 22
- 1 Based on Aptus data on file as of April-15 Excellent Safety
No confirmed late EndoAnchor Fractures or Graft Damage in
>23,000 anchors implanted to date Usage patterns consistent with
ANCHOR In over 4,000 cases to-date, 71% in primary In majority of
primary EVAR cases, EndoAnchors address concerns for late
complications Consistency with ANCHOR Demonstrates registry
reflects real-world use of EndoAnchors 22 ANCHOR Parallels
Commercial Experience 1
- Slide 23
- (1) At most distal renal artery (2)10% diameter change over
10mm length (3)As determined by the investigator Proximal Neck
Anatomical Characteristics (based on Corelab) Primary n=242*
Revision n=77* Max Aneurysm Diameter [mm], mean (+ SD)56 + 1165 +
13 Neck Length [mm], mean (+ SD)17 + 1315 + 12 Necks 10mm Length, N
(%)101 (41.7%)36 (46.5%) Necks 15mm Length, N (%) 141 (58.3%)47
(60.5%) Neck Diameter 1 [mm], mean (+ SD)26 + 429 + 5 Conical Necks
2, %41.7%46.5% Neck Thrombus 2mm37%21% Neck Calcium 2mm48%12%
Hostile Neck 3 53%63% *Note: Corelab sample sizes is different from
total patients in ANCHOR. Corelab for all patients is still
in-process. All above data is per Corelab except the Hostile Neck
line item which is investigator reported. Jordan WD et al. J Vasc
Surg. 2014;60:885-892 23 High Ratio Hostile Neck Anatomy in
ANCHOR
- Slide 24
- Percentage Short Necks by Study Infra-Renal Neck Length* ENGAGE
(Endurant) GREAT 4 (C3 Excluder) ITER 2 (Excluder) OVATION 5
(Trivascular) FORWARD 6 (Nellix) ANCHOR 3 (EndoAnchor)
10mm2.2%1.5%N/A15.5%17%41.7% 15mm4.3%N/A9.5%N/A29%58.3% Mean
Infra-Renal Neck Length 10mm0mm5mm15mm20mm25mm30mm ENGAGE 1
(Endurant) mean: 28mm 1.Pol RA et al. J Vasc Surg 2014;60:308-17
2.Pratesi C et al. J Vasc Surg 2014;59:52-7 3.Jordan WD et al. J
Vasc Surg. 2014;60(4):885-92.e2 4.Verhoeven et al. Eur J Vasc
Endovasc Surg. 2014 Aug;48(2):131-7 ITER 2 (Excluder) mean: 26mm
ANCHOR 3 (EndoAnchor) mean: 16mm GREAT 4 (C3 Excluder) mean: 28mm
OVATION 5 (Trivascular) mean: 23mm 5. Mehta M et al. J Vasc Surg
2014;59:65-73 6. Presentation by Dr. Andrew Holden at
VEITHsymposium 2014 7.Stokmans RA et al. Eur J Vasc Endovasc Surg.
2012 Oct;44(4):369-75 8.Oderich GS et al. J Vasc Surg
2014;60:1420-8. *Cut-offs for neck length may be based on xx mm
or
- Midterm outcomes (14-month mean f/u) exceed expectations from
standard EVAR Shorter necks did NOT have significantly poorer
outcomes 27 Excellent Outcomes as Prophylaxis in ANCHOR, Despite
Majority Hostile Neck Anatomy Jordan WD et al. J Endovascular
Therapy 2015; 22(2):163170 Ruptures, migrations or open surgical
conversions 0.0% (0/208) Freedom from AAA-related
re-interventions96.2% (200/208) 1 Freedom from type Ia endoleaks
per Corelab98.5% (128/130) 2 Freedom from AAA expansion (>5 mm)
per Corelab 98.4% (122/124) 1.N = 1 related to proximal seal:
endograft body collapse in area with no EndoAnchor penetration 2.N
= 2 associated with significant thrombus/calcium and 4- 5mm length
necks
- Slide 28
- Studies Median Follow-Up Type 1 Endoleaks in Hostile Necks
Meta-analysis, Antoniou et al 1 12-Months 20/205* (9.8%) ANCHOR
Registry 2 14.3-Months 2/178** ( 1.1% ) 1.Antoniou GA et al. A
meta-analysis of outcomes of endovascular abdominal aortic aneurysm
repair in patients with hostile and friendly neck anatomy. J Vasc
Surg 2012 2.Podium presentation by W Jordan, Benefit of EndoAnchors
in Endovascular Aneurysm Repair, 2014 Vascular Annual Meeting *
Hostile neck criteria: neck length 60 degrees ** Hostile as
determined by physician in Primary Arm 28 ANCHOR Results vs.
Antoniou et al. Meta-Analysis Seal Durability in F/U Compares
Favorably No EndoAnchor Related SAEs or Re-Interventions Reported
To-Date
- Slide 29
- Late durability data exceeds expectations 2,3 Aptus has the
highest sac regression among all EVAR IDEs at years 2 and 3 1 At
year 3, 82% sacs regressed 1 High sac regression predictor for
lower complications 4 Aptus IDE Study: Highest sac regression,
shortest average neck length among all EVAR IDEs 1 Based on Aptus
data on file as of January 2014 2 Mehta M et al. STAPLE-2: The
Pivotal Study of the Aptus Endovascular AAA Repair System -
24-Months Results. Abstract presented at SVS 2012 3 Mehta M et al.
J Vasc Surg 2014;60(2):275-285 4 Goncalves FB et al. Br J Surg.
2014 Jun;101(7):802-10 [a] No type I endoleak or EndoAnchor
dislocation observed in migrations, no evidence of endograft
movement relative to aortic wall STAPLE-2 Shows Promise to Prevent
Failures 29 EndpointMedian 3.4 yr. Type 1 Endoleak0.0% (0/155)
Graft Migration (>1cm)3.2% (5/155) [a] AAA Ruptures0.0% (0/155)
EndoAnchor-related safety adverse events 0.0% (0/155)
- Slide 30
- Short, reverse taper proximal neck Intraoperative Type I
post-implantation of Cook Zenith 6 EndoAnchors implanted - Type I
endoleak resolved Images from article: Gandi RT and Katzen BT,
Treating a Type Ia Endoleak Using EndoAnchors, Endovascular Today,
March 2012 EndoAnchoring to Target Acute Type I Endoleak 30
- Slide 31
- 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.
EndoAnchoring to Re-Establish Seal in Migration 31
- Slide 32
- 30 -45 LAO 30 -45 RAO C-arm positioning critical for proper
spacing, visualization & implantation Min 4 EndoAnchors
recommended For prox neck dia. > 29mm, min 6 EndoAnchors
recommended Strive for even spacing around neck circumference
EndoAnchors should penetrate vessel wall Select positions lacking
excessive thrombus/calcium Minimum 4 EndoAnchors Recommended Note:
C-arm positions above show just one possible combination
EndoAnchors# of C-arm positions Recommended angular offset 4
EndoAnchors2 ~ 90 6 EndoAnchors3 ~ 60 Tips for EndoAnchor
implantation: 32
- Slide 33
- 30 LAO 30 RAO 90 Lateral 33 C-Arm Positioning for 6 EndoAnchors
Note: C-arm positions above show just one possible combination
- Slide 34
- Move C-Arm in 15-20 degree increments Identify leak channel and
then create a suture line along wall. Circumferential anchoring
before/after T1 EL treatment is recommended: address concerns of
long-term neck morphology changes 34 C-Arm Positioning for T1 EL
Treatment
- Slide 35
- Major EVAR studies highlight late durability limitations e.g.
EVAR 1, ACE, DREAM Greater complications in more hostile proximal
neck anatomies Proximal seal stability remains key EndoAnchors
designed to bring long-term stability of surgical anastomosis to
EVAR Favorable safety profile Maturing data supports hypothesis of
prophylactic benefits Clinical experience shows EndoAnchoring
addresses clear needs in EVAR & TEVAR Augment strength when
concerns exist for late complications Target and treat acute and
late type I endoleaks Conclusions 35
- Slide 36
- Appendix
- Slide 37
- Challenges in Treating Urgent Aneurysm Patients 37 Limited
options FEVAR lead times too excessive CHIMPs outcomes not
definitive May be unfit for open repair Logistical difficulties
Fast treatment needed to stop bleeding in rAAA Time constraints
often preclude proper case planning and graft sizing Complex cases
Anatomical challenges: typically hostile anatomy with short or
angulated infrarenal necks and durability risks Type I endoleaks:
can be lethal, highly critical to prevent onset or treat Types of
patients receiving urgent treatment: Ruptured AAA Symptomatic AAA
Rapid AAA expansion Large AAA diameter Types of patients receiving
urgent treatment: Ruptured AAA Symptomatic AAA Rapid AAA expansion
Large AAA diameter Images courtesy of Nic Nelken MD, Kaiser Hawaii
and ANCHOR investigators 6.5cm diameter AAA Ruptured AAA
- Slide 38
- Need for immediate effective treatment vs. inter-facility
transfer 16% rAAA patients transferred to another facility die
before receiving AAA repair 1 Early benefits realized with EVAR vs.
open repair in rAAA 2 Lower 30-day mortality (24% vs. 40%) Lower
early major complications (58% vs. 76%) However, durability after
EVAR remains problematic 3 Substantially higher late
re-interventions after EVAR 25.8% vs. 4.7% for open repair Endoleak
highest cause of post-EVAR re-interventions Constitute 43.8% of
re-interventions Whereas no endoleaks after open repair Challenges
in Treating Urgent Aneurysm Patients 38 1.Abstract presentation by
Mell MW and colleagues of Stanford University at the 28 th Annual
WVS Meeting 2.von Meijenfeldt GC et al. Eu J Vasc Endovasc Surg.
2014 May;47(5):479-86 3.Rollins KE et al. Br J Surg. 2014
Feb;101(3):225-31.
- Slide 39
- Rapid, high sealing performance in complex anatomy (N=39) 15
minutes average EndoAnchoring time with 100% implantation success
92% freedom from endoleaks at final angio despite >90% hostile
proximal necks Durability maintained in follow-up 0% ruptures, 0%
rebleeds, 0% proximal seal re-interventions (14 month mean clinical
f/u) 0% Type Ia endoleaks per Corelab (3 month mean imaging f/u)
Comparison with historical data shows EndoAnchors may reduce late
type I endoleak risk Substantially lower rates in ANCHOR vs.
comparable studies in standard EVAR Outcomes after Treating Urgent
AAA 1 39 1 Based on abstract presentation at VIVA 2014 late
breaking trials session by Dr. Peter Schneider: EndoAnchors in
Urgent Endovascular Aneurysm Repair: Results from the ANCHOR Global
Registry EndoAnchors shown as a useful adjunct to optimize seal and
address concerns for re-bleed or initial rupture