A New EVAR Device for Infrarenal AAAs

Transcription

1 A New EVAR Device for Infrarenal AAAs Peter Nelson, MD, MS Assistant Professor of Surgery MM0203 Rev. 01

2 Current U.S. EVAR Devices Anatomical Fixation Proximal Fixation Powerlink - Endologix Excluder WL Gore Endurant - Medtronic Zenith Cook

3 The Evolution of Anatomical Fixation 2001 Now Single piece device Proximal fixation Limited Sizes Difficult to use Anatomical fixation Proximal seal with aortic extension Multiple sizes and configurations Easy to use

4 Clinical Results Combined Results of Three Prospective Multicenter Clinical Trials (up to 5 yr follow-up) 157 Patients at 28 U.S. Centers 0% Aneurysm Ruptures 0% Conversion to Open Repair 0% Device Migration 0% Stent Fractures 0% Graft Fatigue 0% Aneurysm-Related Mortality Reduced or Stable Aneurysm Sacs in 93% of Patients at One Year J. ENDOVASC THER. 2010;17:

5 Positive Results in Challenging Neck Anatomies Short Length (<15mm) Severe Thrombus (>3mm over >60% of circumference) Reverse Tapered (>2mm over first 15mm) % Patie ents % 32% 64% 83% Any Characteristic 20 0

6 Anatomical Fixation is Suitable for a Wide Range of Anatomies Difficult Aortic Necks Angulated, Ectatic, Reverse tapered, Thrombus lined, Short Narrow Distal Aortas Patients with Limited Access on one Side Saccular Aneurysms Iliac Aneurysms Patients with PAD Preserves Native Bifurcation Percutaneous Procedures (currently off-label) Standard AAA s

7 Which Graft Should Be Used For? Hostile Necks Iliac Aneurysms Thrombus Laden Bi-lobed Narrow Distal Aorta Saccular Aneurysms Combined LE PAD

8 Angulated Neck Before After

9 Challenging Neck Before After

10 Reverse Conical/Tapered Neck Before After

11 Narrow Distal Aorta Before After

12 Limited Iliac Access Before After

13 Saccular Aneurysm Before After

14 Iliac Aneurysms Before After

15 Which Graft Should Be Used For Patients with Peripheral Artery Disease Limited Contralateral Access Percutaneous Closure (off-label)

16 Preserve the Aortic Bifurcation 16

17 Anatomical Fixation Ability to intervene over the bifurcation for PAD

18 Preserve the Aortic Bifurcation Successful SFA revascularization performed one week post-evar Pre 18 Post

19 Preserve the Aortic Bifurcation Pre Post Successful SFA revascularization performed one week post-evar 19

20 It has all just gotten better

21 Design Objectives (Based Upon Physician Feedback) Reliable Clinical Outcomes Ability to Treat a Wide Range of AAA Anatomies Maintain the Advantages of Anatomical Fixation Preserve the aortic bifurcation No gate cannulation 9f contralateral limb access Expand EVAR to Patients with Difficult Access Precise Delivery and Deployment Optimized Fixation and Seal

22 17Fr Introducer System Access through a 17Fr dilator-introducer sheath Hydrophilic dilator and sheath Exceptional pushability and trackability 19Fr OD Main body bifurcated and extension devices are advanced and deployed through the sheath

23 EVAR Device Profiles Ipsilateral Aortic Neck Diameter (mm) Introducer Size Endologix AFX 17F Medtronic Endurant * 18F 20F Cook Zenith Flex 18F 20F 22F Gore Excluder C3 N/A 18F 20F N/A Contralateral Introducer Size Percutaneous Indication Endologix AFX 9F FDA Approved Medtronic Endurant * 14-16F No Cook Zenith Flex 14-16F No Gore Excluder C F No * The Endurant System does not require the use of an introducer sheath. The device access shown corresponds to the Endurant sheath outside diameter. AFX and STRATA are trademarks of Endologix. All other trademarks are the property of their respective owners. *Lowest profile device in the U.S. to treat aortic necks >22mm in diameter

24 Inroducer Device Profiles (ID) *Lowest profile device in the U.S. to treat aortic necks >22mm in diameter

25 17F Sheath Improves Access Pre-Angio Post Angio

26 Stent Graft Design Highly Durable CoCr Alloy Stent Zero reported stent fractures from 50,000 implants over the past 10 years p p y Metal Fatigue Resistance Explant after 5 years 0 NiTi CoCr

27 Graft Technology Proprietary New eptfe Highly conformable More than 20 layers of eptfe Exceptional strength and impermeability through multilayer processing and bonding

28 Graft Technology 1,200 1, mmhg Normal Aortic Pressure 250 Hypertension Strata Permeability Pressure

29 Dual Proximal Seal 1 st Seal 2 nd Seal Main Body Conformable Strata graft material extends the seal zone

30 Precise Deployment Deployment Dial provides intuitive and precise deployment Ability to make adjustments before final deployment Initial deployment of proximal stent segment Final repositioning/release

31 Initial Implants Neck with extreme angulation and short seal zone below left renal Final angio with Strata graft material conforming to neck and left common iliac artery all the way to external iliac artery

32 Initial Implants Angio showing bilateral iliac disease Narrow Iliac

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34 Initial Experience AFX Procedures Performed to Date: 24 Implants 100% Procedural Success Physician Feedback: 17F sheath provides good access Deployment dial is precise Strata graft material maximizes wall contact and seal

35 Availability FDA Approved Currently building inventory Expect to have devices available in August CE Mark Expected by end of 2011 Will replace IntuiTrak in the U.S. and be used as the platform for Ventana fenestrated stent graft system

36 Summary Positive Initial Clinical Experience 17F sheath provides excellent access Deployment dial very precise St t ft t i l Strata graft material has excellent sealing characteristics

37 Percutaneous EVAR

38 Questions? Thank You

39 Questions? Thank You