1 / 23

Aptus Heli -FX Overview

Aptus Heli -FX Overview. Physician Slide Deck Developed by Aptus Endosystems , Inc. MMA02281401. EVAR 1 Trial Shows Higher 2 nd Interventions in EVAR. Greenhalgh RM et al . N Engl J Med 2010 May 20;362(20):1863-71. 2. ‘DREAM’ Study on LT Outcomes Support EVAR 1.

chapa
Download Presentation

Aptus Heli -FX Overview

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Aptus Heli-FX Overview Physician Slide Deck Developed by AptusEndosystems, Inc. MMA02281401

  2. EVAR 1 Trial Shows Higher 2nd Interventions in EVAR Greenhalgh RM et al. N Engl J Med 2010 May 20;362(20):1863-71 2

  3. ‘DREAM’ Study on LT Outcomes Support EVAR 1 • The DREAM Study evaluated LT survival of Open vs. EVAR Aneurysm Repair in The Netherlands • In EVAR group, significantly more 2ndinterventions 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 2ndinterventions 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

  4. 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 BecqueminJP et al. J VascSurg 2011;53(5):1163-73. 4

  5. Achilles Heel of EVAR Remains Late Failure Noll et al. JVS 2007;46(1):9-15. Abbruzzese et al. JVS 2008;48(1):19-28. Houbballah et al. JVS 2010;52(4):878-83 • 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 endograft-related 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 5

  6. Proximal Seal Stability Remains Key Nordon IM et al. Eur J VascEndovascSurg 2010;39(5):547-54 Lifeline Registry data report. J VascSurg 2005;42(1):1-10 Leurs LJ et al. J EndovascTher 2006;13(5):640-8 Aburahma AF et al. J VascSurg 2009;50(4):738-48 Sternbergh WC et al. J VascSurg 2002;35(3):482-6 Dias NV et al. Eur J VascEndovascSurg 2009;37(4):425-30 • Rates of 2nd interventions in EVAR are high and not improving adequately • Average re-intervention rate of 3.7%/yr from recent registry data1 IDE trial data demonstrate average rate of 4.1%/yr2 • 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 • 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 • No other solutions exist for ‘radial fixation’ to break the cycle of this dilating disease 6

  7. 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 Total sample size: N=1559 patients 1Antoniou GA et al. J Vasc Surg. 2013;57(2):527-38. 7

  8. 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

  9. 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 9

  10. Strategies for Treating Type I Endoleaks Current solutions do not offer consistent effectiveness • 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. 2Jim J et al. J Vasc Surg. 2011 Aug;54(2):307-315. 3Peynircioğlu B et al. DiagnIntervRadiol. 2008 Jun;14(2):111-5. 4Chun JY et al. Eur J VascEndovasc Surg. 2013 Feb;45(2):141-4. 10

  11. The Concept of EndoAnchors Bringing the stability of surgical anastomosis to EVAR Surgical Anastomosis EndoAnchoring Case images courtesy of John ArunyMD, Bart Edward Muhs, MD, PhD and and Burkhart Zipfel, MD. 11

  12. Long-Term Vision of EndoAnchors in EVAR 12

  13. Published Initial Experiences with EndoAnchors 13

  14. Indications for Use (FDA and CE Mark) Medtronic Endurant® Gore Excluder® Cook Zenith® Medtronic Talent® Medtronic AneuRx® 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: 14

  15. 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 • In >10,000 implanted EndoAnchors to-date, no reported late Anchor Dislocations, Fractures, Graft Damage or Fistula2 • 400MM cycles fatigue testing2 No damage post 400M cycles, equivalent to 10 years in vivo 1Based on article: ANCHOR registry demonstrates safety and technical success of utilizing endoanchorsin primary and revision EVAR Vascular News 11 Oct 2013 2Based on commercial and study on file at Aptus Images courtesy of Aptus Endosystems, Inc. 15

  16. ANCHOR Registry capturing real-world usage Over 350 Patients enrolled as of Feb 2014 16

  17. Heli-FX System: Applier + Guide + 10 EndoAnchors 3 mm Cross Bar 1.0 mm 3.5 mm Images courtesy of Aptus Endosystems, Inc. 17

  18. 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. 18

  19. EndoAnchor Deployment Animation 19

  20. EndoAnchors: Which Patients Can Benefit? PROPHYLAXIS TREATMENT 20

  21. 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

  22. 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 VascSurg 2011; 54:1792-4. 22

  23. 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

More Related