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Aptus Heli -FX Overview

Aptus Heli -FX Overview. Physician Slide Deck Developed by Aptus Endosystems , Inc. MMA09051401. Major Studies Show Higher 2 nd Interventions in EVAR vs. Open Repair. DREAM. ACE. EVAR-1. R.M. Greenhalgh et al . N Engl J Med 2010, 10.1056/NEJM 0909305.

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Aptus Heli -FX Overview

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  1. Aptus Heli-FX Overview Physician Slide Deck Developed by Aptus Endosystems, Inc. MMA09051401

  2. Major Studies Show Higher 2nd Interventions in EVAR vs. Open Repair DREAM ACE EVAR-1 R.M. Greenhalgh et al. N Engl J Med 2010, 10.1056/NEJM 0909305 BecqueminJP et al. J VascSurg 2011;53(5):1163-73. De Bruin et al. N Engl J Med 2010;362:1881-9 • 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

  3. Hostile Proximal Necks Further Challenge EVAR Meta-Analysis of 7 major studies in EVAR by Antoniou et al1 compared outcomes in hostile vs. friendly neck anatomies (total patients N = 1559) • 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 greaterin hostile neck anatomy (P= .013) 1Antoniou GA et al. J Vasc Surg. 2013;57(2):527-38.

  4. Hostile Proximal Necks Further Challenge EVAR Another similar meta-analysis by Stather et al. of 16 major studies confirms higher risks in hostile necks Total sample size: N=11,959 patients • Further substantiation that EVAR still faces significant challenges in hostile proximal neck anatomy Stather PW et al. J EndovascTher. 2013;20:623–637

  5. Influence of Multiple Hostile Neck Parameters Speziale et al. shows greater proximal seal complication risks as the number of hostile neck parameters increases Greater than 1 hostile neck parameter significantly increases mortality, major adverse events, intra-op endoleaks and adjunctive procedures Speziale F et al, Annals of Vascular Surgery (2014), doi: 10.1016/j.avsg.2014.06.057.

  6. Neck Dilatation: A Cause for 2nd Intervention Multiple recent studies confirm neck dilatation in EVAR remains REAL 1Oberhuber A et al. J VascSurg 2012 April;55(4): 929-34 2Pintoux D et al. Ann Vasc Surg. 2011 Nov;25(8):1012-9 3Bastos Goncalves F et al. J Vasc Surg. 2012 Oct;56(4):920-8

  7. Compromise of EVAR and Long-Term F/U • Nordon IM et al. Eur J VascEndovascSurg 2010;39(5):547-54. • Dias NV et al. Eur J VascEndovascSurg 2009;37(4):425-30.

  8. Type I Endoleak? What Have Been Our Options… What do we do when? • Standard revision techniques cannot be used or don’t seal endoleak? • Patients are unfit for FEVAR or open surgical conversion? *Ballooning, cuffs, Palmaz, coils, Onyx and/or CHIMPs may be considered in EVAR/TEVAR revision Image courtesy of National Institute of Health Image courtesy of National Institute of Health

  9. Tailored Seal and Fixation of EndoAnchors Create the stability of A surgical anastomosis In EVAR and TEVAR Surgical Anastomosis EndoAnchoring Displacement force in Newtons Chart from data published in MelasN, et al. J VascSurg 2012;55(6):1726-33 Case images courtesy of John ArunyMD, Bart Edward Muhs, MD, PhD.

  10. Long-Term Objectives of EndoAnchors in EVAR Legend: Status of clinical substantiation Completed In-process Next phase

  11. Heli-FX Indications for Use (FDA and CE Mark) Jotec GmbH Cook Zenith Medtronic Talent Gore Excluder Medtronic AneuRx Medtronic Endurant 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:

  12. How to Manage EVAR with EndoAnchors? PROPHYLAXIS TREATMENT Case image from Gandhi RT, Katzen BT Treating a Type 1A Endoleak Using EndoAnchors. Endovascular Today March 2012 23:26.

  13. EndoAnchor Tailored Seal and Fixation • Performance • Verified equivalence to the strength of a surgical anastomosis1 • Designed to provide radial support and resist neck dilatation • Safety • In >2,700 cases and >16,000 EndoAnchors implanted to-date, no confirmed graft damage, late anchor dislocation, fracture or fistula 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 EndoAnchorplacement • Motorized controls for two-stage EndoAnchordeployment with repositioning No damage post 400M cycles, equivalent to 10 years in vivo 1 Melas N et al, J VascSurg2012;55:1726-33 2Jordan WD et al, J Vasc Surg 2014 Jul 31. pii: S0741-5214(14)00929-X. doi: 10.1016/j.jvs.2014.04.063 3Based on data on file at Aptus as of Sept 2014 Images courtesy of Aptus Endosystems, Inc.

  14. Heli-FX System: Applier + Guide + 10 EndoAnchors 3 mm Cross Bar 1.0 mm 3.5 mm Images courtesy of Aptus Endosystems, Inc.

  15. 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.

  16. EndoAnchor Deployment Animation

  17. ANCHOR Registry capturing real-world usage Over 450 Patients enrolled as of Sept2014

  18. ANCHOR Shows High Prophylactic Use Indications for EndoAnchoring in Primary n=307 Indications for EndoAnchoring in Revision n=99 Jordan et al. Early results of the ANCHOR prospective multicenter registry of EndoAnchors for type IA endoleaks and endograft migration in patients with challenging anatomy J VascSurg 2014; Article in Press

  19. ANCHOR Includes All Major Endografts Complex AAA and complications have warranted EndoAnchor tailored seal and fixation with ALL major endografts • Confirms that the EndoAnchoring need is independent of endograft design  need due to challenges of hostile anatomy and post-implant disease progression Jordan WD et al. J Vasc Surg. 2014 Jul 31. pii: S0741-5214(14)00929-X. doi: 10.1016/j.jvs.2014.04.063

  20. ANCHOR Utilization Parallels Commercial Experience1 • Excellent Safety • No confirmed late Anchor Dislocations, Fractures, Graft Damage or Fistula in >16,000 anchors implanted to date • Usage patterns consistent with ANCHOR • In over 2,700 cases to-date, 71% in primary • Majority of primary EVAR cases used EndoAnchors to address concerns for late complications • Consistency with ANCHOR • Demonstrates registry reflects real-world use of EndoAnchors 1Based on Aptus data on file as of Sept-14

  21. High Ratio Hostile Neck Anatomy in ANCHOR (1) At most distal renal artery • ≥10% diameter change over 10mm length • As determined by the investigator *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 et al. Early results of the ANCHOR prospective multicenter registry of EndoAnchors for type IA endoleaks and endograft migration in patients with challenging anatomy J VascSurg 2014; J Vasc Surg. 2014 Jul 31. pii: S0741-5214(14)00929-X. doi: 10.1016/j.jvs.2014.04.063

  22. Procedure Success w/Freedom from Type Ia Endoleak at Final AngioRemains Excellent . . . Despite Hostile Proximal Neck Anatomy • High success in treating type I endoleaks • 83% for acute T1 ELs in primary • 80% for late T1 ELs in revision • In majority of persisting type I endoleaks, standard adjuncts failed to treat or could not be administered • Reflect high ability for EndoAnchors to treat difficult endoleaks Jordan et al. Early results of the ANCHOR prospective multicenter registry of EndoAnchors for type IA endoleaks and endograft migration in patients with challenging anatomy J VascSurg 2014; Article in Press

  23. Re-Interventions Over 9-Mo Mean F/U Seal Durability Exceeds Expectations from Standard EVAR in Hostile Proximal Neck Anatomy Jordan et al. Early results of the ANCHOR prospective multicenter registry of EndoAnchors for type IA endoleaks and endograft migration in patients with challenging anatomy J VascSurg 2014; Article in Press

  24. Seal Durability in F/U Compares Favorably ANCHOR Results vs. Antoniou et al. Meta-Analysis 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 Podium presentation by W Jordan, “Benefit of EndoAnchors in Endovascular Aneurysm Repair,” 2014 Vascular Annual Meeting * Hostile neck criteria: neck length <15 mm and neck angulation > 60 degrees ** Hostile as determined by physician in Primary Arm No EndoAnchor Related SAEs or Re-Interventions Reported To-Date

  25. STAPLE-2 Shows Promise to Prevent Late Failures Aptus IDE Study: Highest sac regression, shortest average neck length among all EVAR IDEs • Late durability data exceeds expectations2,3 • Aptus has the highest sac regression among all EVAR IDEs at years 2 and 31 • At year 3, 82% sacs regressed1 • High sac regression predictor for lower complications4 [a] No type I endoleak or EndoAnchor dislocation observed in migrations, no evidence of endograft movement relative to aortic wall 1Based on Aptus data on file as of January 2014 2Mehta M et al. STAPLE-2: The Pivotal Study of the Aptus Endovascular AAA Repair System - 24-Months Results. Abstract presented at SVS 2012 3Mehta M et al. J VascSurg 2014;60(2):275-285 4Goncalves FB et al. Br J Surg. 2014 Jun;101(7):802-10

  26. EndoAnchoring to Target Acute Type I Endoleak • 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

  27. EndoAnchoring to Re-Establish Seal in Late Migration • 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 VascSurg 2011; 54:1792-4.

  28. Min 4 EndoAnchors for Circumferential Anchoring Tips for EndoAnchor implantation: 30º-45ºLAO 30º-45ºRAO • 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 Note: C-arm positions above show just one possible combination

  29. C-Arm Positioning for 6 EndoAnchors 30º LAO 30º RAO 90º Lateral Note: C-arm positions above show just one possible combination

  30. C-Arm Positioning for T1 EL Treatment 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

  31. Conclusions • 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

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