A New EVAR Device for Infrarenal AAAs Peter Nelson, MD, MS Assistant Professor of Surgery MM0203 Rev. 01
Current U.S. EVAR Devices Anatomical Fixation Proximal Fixation Powerlink - Endologix Excluder WL Gore Endurant - Medtronic Zenith Cook
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
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;17:153-152 4
Positive Results in Challenging Neck Anatomies Short Length (<15mm) Severe Thrombus (>3mm over >60% of circumference) Reverse Tapered (>2mm over first 15mm) % Patie ents 100 80 60 40 14% 32% 64% 83% Any Characteristic 20 0
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
Which Graft Should Be Used For? Hostile Necks Iliac Aneurysms Thrombus Laden Bi-lobed Narrow Distal Aorta Saccular Aneurysms Combined LE PAD
Angulated Neck Before After
Challenging Neck Before After
Reverse Conical/Tapered Neck Before After
Narrow Distal Aorta Before After
Limited Iliac Access Before After
Saccular Aneurysm Before After
Iliac Aneurysms Before After
Which Graft Should Be Used For Patients with Peripheral Artery Disease Limited Contralateral Access Percutaneous Closure (off-label)
Preserve the Aortic Bifurcation 16
Anatomical Fixation Ability to intervene over the bifurcation for PAD
Preserve the Aortic Bifurcation Successful SFA revascularization performed one week post-evar Pre 18 Post
Preserve the Aortic Bifurcation Pre Post Successful SFA revascularization performed one week post-evar 19
It has all just gotten better
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
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
EVAR Device Profiles Ipsilateral Aortic Neck Diameter (mm) 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 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 C3 12-18F 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
Inroducer Device Profiles (ID) *Lowest profile device in the U.S. to treat aortic necks >22mm in diameter
17F Sheath Improves Access Pre-Angio Post Angio
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 10 8 6 4 2 Explant after 5 years 0 NiTi CoCr
Graft Technology Proprietary New eptfe Highly conformable More than 20 layers of eptfe Exceptional strength and impermeability through multilayer processing and bonding
Graft Technology 1,200 1,000 900 mmhg 600 300-120 Normal Aortic Pressure 250 Hypertension Strata Permeability Pressure
Dual Proximal Seal 1 st Seal 2 nd Seal Main Body Conformable Strata graft material extends the seal zone
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
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
Initial Implants Angio showing bilateral iliac disease Narrow Iliac
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
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
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
Percutaneous EVAR
Questions? Thank You
Questions? Thank You