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MMA02281401

Aptus Heli-FX Overview

Physician Slide Deck

Developed by Aptus Endosystems, Inc.

EVAR 1 Trial Shows Higher 2

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 2 nd 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

$ 18, 586

EVAR

$ 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 2 nd interventions to prevent ruptures (p=0.03) • Surgical 2 nd interventions primarily incision hernia (not life critical) • EVAR 2 nd interventions primarily endoleak and migration (life critical) 2.Trend of 2 nd 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 2 nd Interventions = 16% Open surgery = 2.4% at median f/u of 3 years The EVAR group had significantly more 2

durable option’

nd interventions, and open surgery remains a ‘more Death free survival or freedom from 2 nd intervention Becquemin JP et al. J Vasc Surg 2011;53(5):1163-73.

Achilles Heel of EVAR Remains Late Failure

• 19.9% of pts require an average of 1.9 secondary interventions within 5 years of EVAR 1 • 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 costs 1 • • EVAR in difficult anatomy increases the need for secondary intervention 2,3 37.3% of interventions are associated with endograft related endoleaks and/or migration - Costs average $8,722 – $21,382 to address endograft-related endoleak or migration 1  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 • Average re-intervention rate of 3.7%/yr from recent registry data 1 IDE trial data demonstrate average rate of 4.1%/yr 2 • Complicated anatomy results in more Type I endoleaks & higher re-intervention risk • • • Short neck length (<15mm) 3,4 Neck angulation (>40º) 5 More complicated patients are being treated as EVAR devices improve

Re-intervention-free survival 1

1 yr 89.9% 2 yr 5 yr 86.9% 81.5% • There is acceptance that current standard follow-up imaging… • • • Carries risk (radiation, contrast media) 1,6 Is expensive 1,6 Confers suboptimal benefit (<10% of re-interventions are triggered by routine follow-up imaging findings) 6

Increased odds of type I endoleak and need for re-intervention Risk Factor OR (95% CI)

Neck Length < 15 mm 2.2 (1.4-3.5) 3,† 6.2 (2.9-13) 4,† 4.3 (2.1-8.7) 4,‡ Neck angulation > 40° 5.9 (1.3-27.6) 5, *  No other solutions exist for ‘radial fixation’ to break the cycle of this dilating disease 1.

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 6

Hostile Necks Continue to Challenge Durability

Meta-Analysis of 7 major studies in EVAR by Antoniou et al 1 comparing outcomes in hostile vs. friendly neck anatomies

Study

Torsello et al, 2011 AbuRahma et al, 2010 Hoshina et al, 2010 Abbruzzese et al, 2008 Choke et al, 2006 Fulton et al, 2006 Fairman et al, 2004

Sample Size

177 238 129 565 147 84 219

Major Grafts

Endurant AneuRx, Excluder, Zenith, Talent Excluder, Zenith AneuRx, Excluder, Zenith Talent, Zenith, Excluder, AneuRx AneuRx Talent Total sample size: N=1559 patients 1 Antoniou GA et al. J Vasc Surg. 2013;57(2):527-38.

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.

Neck Dilatation: A Cause for 2

Intervention

Multiple recent studies confirm neck dilatation in EVAR remains REAL

Author

Oberhuber et al.

1 Pintoux et al.

Follow Up

39 mos average 57 mos average

Grafts studied

Zenith (N=29), Talent (N=35), Excluder (N=39) Talent (N=33), Aneurx (N=25) Bastos Gonçalves et al.

3 5 yrs median Excluder (N=144)

Proximal Neck Dilatation Rate

22% (defined as >2mm diam increase) 24% (defined as >3mm diam increase) 37% overall, 66% in pts >7 yrs f/u (defined as >2mm diam increase)

Outcomes in dilated necks

31% re-interventions 5% late type Ia endoleak 16% migration 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 9

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 procedure 1 • 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 placement 2 Limitations with Coils and Onyx • Require precise ID of leak paths: non-target embolization risk 3 • Time consuming 4 • Onyx could create CT artifacts precluding identification of endoleaks in F/U 4 • • •

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

10 1 Byrne J et al. Ann Vasc Surg. 2013 May;27(4):401-11.

2 Jim J et al. J Vasc Surg. 2011 Aug;54(2):307-315.

3 Peynircioğlu B et al. Diagn Interv Radiol. 2008 Jun;14(2):111-5.

4 Chun JY et al. Eur J Vasc Endovasc Surg. 2013 Feb;45(2):141-4.

The Concept of EndoAnchors

BRINGING THE STABILITY OF SURGICAL ANASTOMOSIS TO EVAR Surgical Anastomosis EndoAnchoring

11 Case images courtesy of John Aruny MD, Bart Edward Muhs, MD, PhD and and Burkhart Zipfel, MD.

Long-Term Vision of EndoAnchors in EVAR

Prevent late term seal complications in primary setting Treat seal complications & prevent recurrence in revision setting Replicate surgical anastomosis, arrest neck dilatation Mitigate reinterventions , expand candidates for EVAR 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

• Melas et al J Vasc Surg. 2012;55(6):1726-1733 • Gomero-Cure et al J Vasc Surg. 2012;55:1S Experience in

Primary EVAR

• Perdikides et al J Endovasc Ther. 2012;19.

Experience in

EVAR Revision

• 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.

TEVAR experience • Kasprzak et al. J Endovasc Ther. 2013 Aug;20(4).

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 registry 1  Demonstrated safety in >2,000 pts treated – In >10,000 implanted EndoAnchors to-date, no reported late Anchor Dislocations, Fractures, Graft Damage or Fistula 2 – 400MM cycles fatigue testing 2 Images courtesy of Aptus Endosystems, Inc.

15 No damage post 400M cycles, equivalent to 10 years in vivo 1 Based on article: ANCHOR registry demonstrates safety and technical success of utilizing endoanchors in primary and revision EVAR Vascular News 11 Oct 2013 2 Based on commercial and study on file at Aptus

**ANCHOR Registry capturing real-world usage**

Registry Principal Investigators Registry Design Treatment Arms Duration Follow-up Europe: Dr. Jean-Paul de Vries – Hospital Chief of Vascular Surgery, St. Antonius US: Dr. William Jordan – Univ. of Alabama Chief of Vascular Surgery/Endovascular Therapy, Prospective, observational, international, multi-center, dual-arm Registry “Primary” – Up to 1000 pts, Prophylactic “Revision” – Up to 1000 pts, Therapeutic 5 Years Per Standard of Care at each center & discretion of Investigator

Over 350 Patients enrolled as of Feb 2014

Heli-FX System: Applier + Guide + 10 EndoAnchors

3 mm Cross Bar 1.0 mm 3.5 mm Images courtesy of Aptus Endosystems, Inc.

Aptus Heli-FX Product Offerings

Aptus™ Heli-FX™ Thoracic EndoAnchor ™System

18Fr OD, 90cm working length

Aptus™ Heli-FX™ EndoAnchor™ System Images courtesy of National Institute of Health and Aptus Endosystems, Inc.

16Fr OD, 62cm working length

EndoAnchor Deployment Animation

EndoAnchors: Which Patients Can Benefit?

PROPHYLAXIS TREATMENT

Hostile Anatomy Overcoming concerns for implant stability Normal Anatomy Mitigating risk of re interventions Resolve proximal seal failures

Challenging neck anatomies (e.g. wide, short, conical, angulated) Difficult landing (e.g. birdbeaking, close to branched vessels) Severe comorbidities that preclude safe re intervention Patients potentially lost during F/U Long remaining life expectancy (young pts) Acute type I endoleaks during primary procedure Late-term type I endoleaks Augmenting stability in migrated grafts 20

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 21

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.

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 23