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Aptus Heli-FX OverviewPhysician Slide Deck

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MMA02281401EVAR 1 Trial Shows Higher 2nd Interventions in EVAR

Open SurgeryEVAR$ 18, 586$ 23,153Greenhalgh RM et al. N Engl J Med 2010 May 20;362(20):1863-712The DREAM Study evaluated LT survival of Open vs. EVAR Aneurysm Repair in The NetherlandsIn 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

DREAM Study on LT Outcomes Support EVAR 13

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 interventionBecquemin JP et al. J Vasc Surg 2011;53(5):1163-73.4ACE Trial Confirms EVAR Late Durability Limitations19.9% of pts require an average of 1.9 secondary interventions within 5 years of EVAR1Patients 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, p2mm diam increase)31% re-interventionsPintoux et al.257 mos averageTalent (N=33), Aneurx (N=25)24%(defined as >3mm diam increase)5% late type Ia endoleak16% migrationBastos Gonalves et al.35 yrs medianExcluder (N=144)37% overall,66% in pts >7 yrs f/u (defined as >2mm diam increase)Increased odds of migration (5mm) 5.5x1Oberhuber A et al. J Vasc Surg 2012 April;55(4): 929-342Pintoux D et al. Ann Vasc Surg. 2011 Nov;25(8):1012-93Bastos Goncalves F et al. J Vasc Surg. 2012 Oct;56(4):920-8Multiple recent studies confirm neck dilatation in EVAR remains REALNeck Dilatation: A Cause for 2nd Intervention91Byrne J et al. Ann Vasc Surg. 2013 May;27(4):401-11.2Jim J et al. J Vasc Surg. 2011 Aug;54(2):307-315.3Peynirciolu 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.None of these resist further neck dilatationFrequently multiple devices needed, adding time & cost Palmaz, coils, Onyx not indicated for Tx of Type I EndoleakCurrent solutions do not offer consistent effectivenessStrategies for Treating Type I Endoleaks10

EndoAnchoringSurgical AnastomosisCase images courtesy of John Aruny MD, Bart Edward Muhs, MD, PhD and and Burkhart Zipfel, MD.

The Concept of EndoAnchors11Bringing the stability of surgical anastomosis to EVARLong-Term Vision of EndoAnchors in EVAR12Published Initial Experiences with EndoAnchors13The Heli-FX EndoAnchor System is intended to provide fixation and augment sealing between endovascular aortic grafts and the aortaThe Heli-FX EndoAnchor System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complicationsThe Aptus EndoAnchor and Heli-FX have been evaluated and determined to be compatible with the following endografts:

Cook ZenithGore Excluder

Medtronic AneuRxMedtronic EndurantMedtronic TalentIndications for Use (FDA and CE Mark)1414No late Type 1 endoleak in 4-5 year f/uSTAPLE-1 & 2 IDE studyHigh success in treating late Type I Endoleaks>90% success in revision cases per ANCHOR registry1Demonstrated safety in >2,000 pts treatedIn >10,000 implanted EndoAnchors to-date, no reported late Anchor Dislocations, Fractures, Graft Damage or Fistula2400MM cycles fatigue testing2Heli-FX for Managing Late Seal Complications

151Based on article: ANCHOR registry demonstrates safety and technical success of utilizing endoanchors in primary and revision EVAR Vascular News 11 Oct 20132Based on commercial and study on file at Aptus No damage post 400M cycles, equivalent to 10 years in vivo

Images courtesy of Aptus Endosystems, Inc.

Over 350 Patients enrolled as of Feb 201416Registry Principal InvestigatorsEurope: Dr. Jean-Paul de Vries Chief of Vascular Surgery, St. Antonius HospitalUS: Dr. William Jordan Chief of Vascular Surgery/Endovascular Therapy, Univ. of Alabama Registry DesignProspective, observational, international, multi-center, dual-arm Registry Treatment ArmsPrimary Up to 1000 pts, ProphylacticRevision Up to 1000 pts, TherapeuticDuration5 YearsFollow-upPer Standard of Care at each center & discretion of InvestigatorANCHOR Registry capturing real-world usage

Cross Bar3 mm1.0 mm3.5 mm

Heli-FX System: Applier + Guide + 10 EndoAnchors17

Images courtesy of Aptus Endosystems, Inc.

Aptus Heli-FX Thoracic EndoAnchor SystemAptus Heli-FX EndoAnchor System16Fr OD,62cm working length18Fr OD,90cm working lengthAptus Heli-FX Product Offerings18

Images courtesy of National Institute of Health and Aptus Endosystems, Inc.

EndoAnchor Deployment Animation19TREATMENTPROPHYLAXISEndoAnchors: Which Patients Can Benefit?20Short, reverse taper proximal neckIntraoperative Type I post-implantation of Cook Zenith6 EndoAnchors implanted - Type I endoleak resolvedImage s from article: Gandi RT and Katzen BT, Treating a Type Ia Endoleak Using EndoAnchors, Endovascular Today, March 2012

Case Example EndoAnchors in Primary EVAR21

3 year F/U showed migrated Talent with type Ia endoleakEndurant cuff and EndoAnchors implanted - endoleak resolvedImages 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.Case Example EndoAnchors in EVAR Revision22

Major EVAR studies highlight late durability limitationse.g. EVAR 1, ACE, DREAMProximal seal stability remains keyEndoAnchors designed to bring long-term stability of surgical anastomosis to EVARHigh safety and efficacyDemonstrated safety profileHigh success in type I endoleak Tx per ANCHOR registryMore definitive data for prevention in-process

Conclusions23