Presentation on theme: "Aptus Heli-FX Overview Physician Slide Deck Developed by Aptus Endosystems, Inc. MMA02281401."— Presentation transcript:
Aptus Heli-FX Overview Physician Slide Deck Developed by Aptus Endosystems, Inc. MMA
EVAR 1 Trial Shows Higher 2 nd Interventions in EVAR EVAR is significantly more expensive overall Due to associated long term follow-up and secondary interventions 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 One of most important recent papers to date on long term outcomes of EVAR: authors conclude: Open SurgeryEVAR $ 18, 586$ 23,153 Greenhalgh RM et al. N Engl J Med 2010 May 20;362(20):
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: ‘DREAM’ Study on LT Outcomes Support EVAR 1 3
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 nd interventions, and open surgery remains a ‘more durable option’ Death free survival or freedom from 2 nd intervention Becquemin JP et al. J Vasc Surg 2011;53(5): ACE Trial Confirms EVAR Late Durability Limitations
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): Abbruzzese et al. JVS 2008;48(1): Houbballah et al. JVS 2010;52(4): Achilles Heel of EVAR Remains Late Failure
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 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 No other solutions exist for ‘radial fixation’ to break the cycle of this dilating disease Re-intervention-free survival 1 1 yr89.9% 2 yr86.9% 5 yr81.5% Increased odds of type I endoleak and need for re-intervention Risk Factor OR (95% CI) Neck Length < 15 mm 2.2 ( ) 3,† 6.2 (2.9-13) 4,† 4.3 ( ) 4,‡ Neck angulation > 40°5.9 ( ) 5, * 1.Nordon IM et al. Eur J Vasc Endovasc Surg 2010;39(5): Lifeline Registry data report. J Vasc Surg 2005;42(1): Leurs LJ et al. J Endovasc Ther 2006;13(5): Aburahma AF et al. J Vasc Surg 2009;50(4): Sternbergh WC et al. J Vasc Surg 2002;35(3): Dias NV et al. Eur J Vasc Endovasc Surg 2009;37(4): Proximal Seal Stability Remains Key
StudySample SizeMajor Grafts Torsello et al, Endurant AbuRahma et al, AneuRx, Excluder, Zenith, Talent Hoshina et al, Excluder, Zenith Abbruzzese et al, AneuRx, Excluder, Zenith Choke et al, Talent, Zenith, Excluder, AneuRx Fulton et al, AneuRx Fairman et al, Talent Meta-Analysis of 7 major studies in EVAR by Antoniou et al 1 comparing outcomes in hostile vs. friendly neck anatomies 1 Antoniou GA et al. J Vasc Surg. 2013;57(2): Total sample size: N=1559 patients Hostile Necks Continue to Challenge Durability 7
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) Major findings: Antoniou GA et al. J Vasc Surg. 2013;57(2): Hostile Necks Continue to Challenge Durability 8
AuthorFollow- Up Grafts studiedProximal Neck Dilatation Rate Outcomes in dilated necks Oberhuber et al mos average Zenith (N=29), Talent (N=35), Excluder (N=39) 22% (defined as >2mm diam increase) 31% re-interventions Pintoux et al mos average Talent (N=33), Aneurx (N=25) 24% (defined as >3mm diam increase) 5% late type Ia endoleak 16% migration Bastos Gonçalves 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): Pintoux D et al. Ann Vasc Surg Nov;25(8): Bastos Goncalves F et al. J Vasc Surg Oct;56(4):920-8 Multiple recent studies confirm neck dilatation in EVAR remains REAL Neck Dilatation: A Cause for 2 nd Intervention 9
1 Byrne J et al. Ann Vasc Surg May;27(4): Jim J et al. J Vasc Surg Aug;54(2): Peynircioğlu B et al. Diagn Interv Radiol Jun;14(2): Chun JY et al. Eur J Vasc Endovasc Surg Feb;45(2): 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 Palmaz effectiveness is limited 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 Mixed results with Cuffs 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 Limitations with Coils and Onyx 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 Current solutions do not offer consistent effectiveness Strategies for Treating Type I Endoleaks 10
EndoAnchoringSurgical Anastomosis Case images courtesy of John Aruny MD, Bart Edward Muhs, MD, PhD and and Burkhart Zipfel, MD. The Concept of EndoAnchors 11 BRINGING THE STABILITY OF SURGICAL ANASTOMOSIS TO EVAR
Replicate surgical anastomosis, arrest neck dilatation Prevent late term seal complications in primary setting Treat seal complications & prevent recurrence in revision setting Mitigate reinterventions, expand candidates for EVAR Reduce follow-up by preventing type I leaks and sac growth Long-Term Vision of EndoAnchors in EVAR 12
Melas et al J Vasc Surg. 2012;55(6): Gomero-Cure et al J Vasc Surg. 2012;55:1S Feasibility in replicating surgical anastomosis and arresting neck dilatation Perdikides et al J Endovasc Ther. 2012;19. Experience in Primary EVAR Hogendoorn W et al. Ann Vasc Surg 2013; doi: /j.avsg Avci et al J Cardiovasc Surg. 2012; 53: de Vries et al J Vasc Surg. 2011;54: Experience in EVAR Revision Kasprzak et al. J Endovasc Ther Aug;20(4). TEVAR experience Published Initial Experiences with EndoAnchors 13
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: Cook Zenith ® Gore Excluder ® Medtronic AneuRx ® Medtronic Endurant ® Medtronic Talent ® Indications for Use (FDA and CE Mark) 14
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 Heli-FX™ for Managing Late Seal Complications 15 1 Based on article: ANCHOR registry demonstrates safety and technical success of utilizing endoanchors in primary and revision EVAR Vascular News 11 Oct Based 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 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
Cross Bar 3 mm 1.0 mm 3.5 mm Heli-FX System: Applier + Guide + 10 EndoAnchors 17 Images courtesy of Aptus Endosystems, Inc.
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 18 Images courtesy of National Institute of Health and Aptus Endosystems, Inc.
EndoAnchor Deployment Animation 19
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 Acute type I endoleaks during primary procedure Late-term type I endoleaks Augmenting stability in migrated grafts EndoAnchors: Which Patients Can Benefit? 20
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 Case Example – EndoAnchors in Primary EVAR 21
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: Case Example – EndoAnchors in EVAR Revision 22
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 Conclusions 23