LOWERING THE PROFILE RAISING THE BAR

Transcription

1 LOWERING THE PROFILE RAISING THE BAR

2 INNOVATIVE LOW PROFILE. ADVANCED CLINICAL PERFORMANCE. The AFX TM Endovascular AAA System integrates anatomical fixation with an advanced delivery system and graft material technology to treat a wide range of AAA anatomies. Access Low profile sheath for smooth tracking and delivery Control Highly predictable and accurate deployment Seal STRATA TM multilayer eptfe graft material for strength and conformability 17 F Hydrophilic Introducer Sheath Precise Deployment Dial

3 STRATA multilayer eptfe provides both strength and seal. Redefining eptfe Graft Performance Highly conformable eptfe maximizes wall contact. Anatomical Fixation Provides device stability and preserves the bifurcation for future endovascular procedures.

4 ONE SHEATH FOR ALL SIZES. AFX is the only EVAR system that utilizes a single low profile 17 F introducer sheath with a dilator to gain access in a wide range of AAA patients. AFX Delivery System Low profile introducer sheath provides unparalled access to treat more patients Hydrophilic coating for smooth delivery Sheath-dilator system provides exceptional pushability and tracking in tortuous vessels EVAR DEVICE ACCESS Ipsilateral Endologix AFX Medtronic Endurant TM * Cook Zenith Flex Gore Excluder C3 Aortic Neck N/A 17 F 18 F 20 F 18 F 20 F 22 F 18 F Introducer Size 20 F N/A Contralateral Endologix AFX Medtronic Endurant* Cook Zenith Flex Gore Excluder C3 Introducer Size 9 F FDA Approved F F F Percutaneous Indication No No No *The Endurant System does not use an introducer sheath. The device access shown corresponds to the Endurant outside diameter.

5 PREDICTABLE, CONSISTENT AND ACCURATE DEPLOYMENT. The AFX delivery system provides the predictability and control to navigate a wide range of anatomies and precisely deploy the device. Accurate and quick deployment with the control dial No gate cannulation required

6 PROVEN CLINICAL PERFORMANCE OF ANATOMICAL FIXATION. Clinical Trial Results from Three Prospective Multicenter Studies Migration...0% Aneurysm rupture...0% Conversion to open repair...0% Stent fracture...0% Aneurysm related mortality...0% Gate cannulation time...0 minutes Patient Profiles 1 N =157 Mean AAA diameter (cm): 5.6 ± 0.9 Mean proximal neck diameter : 29 ± 4 Prevalence of PAD 27% Hostile Neck Anatomies Short (<15 mm) 14% Severe Thrombus (>3 mm over >60% of circumference) 2 32% Reverse Taper (>2 mm over first 15 mm) 2 64% Any of the 3 Anatomies 83% % Patients Low Rate of EVAR Limb Interventions Patients Requiring Adjunctive Stenting and Interventions (reported through late follow-up) % 3.3% 2.8% 1.7% 1.2% 0 Endurant Medtronic US PMA 3 Talent Medtronic van Marrewijk Zenith Cook Greenberg Excluder Gore van Marrewijk Powerlink Endologix Carpenter Carpenter JP et al. Contemporary results of endovascular repair of abdominal aortic aneurysms: effects of anatomical fixation on outcomes. J Endovas Ther. 2010; 17(2): Data on file. 3. P100021: FDA summary of safety and effectiveness data 4. van Marrewijk CJ et. al. Risk-adjusted outcome analysis of endovascular abdominal aortic aneurysm repair in a large population: how do stent-grafts compare? J Endovasc Ther 2005;12: Greenberg RK et. al. Zenith abdominal aortic aneurysm endovascular graft. J Vasc Surg 2008;48:1-9

7 AFX TM SYSTEM SPECIFICATIONS Bifurcated Unibody Devices B A / I Aortic Extensions A / C 95 - O20 Bifurcated Aortic Dimensions Main Body Main Body Iliac Dimensions Limb Bifurcated Stent Graft Limb Bifurcated Aortic Dimensions Iliac Dimensions B A / I B A / I B A / I B A / I B A / I B A / I B A / I B A / I B A / I B A / I B A / I B A / I B A / I B A / I B A / I B A / I B A / I B A / I B A / I B A / I B A / I B A / I B A / I B A / I Aortic Dimensions Proximal Distal Covered Open * *Not present on Suprarenal Aortic Extension infrarenal extensions Proximal Aortic Dimensions Distal Covered Open A / C 95 - O 20 A / C 75 - O 20 A / C 55 - O 20 A / C 95 - O 20 A / C 55 - O 20 A / C 75 - O 20 A / C 80 - O 20 A / C O 20 Infrarenal Aortic Extension Aortic Dimensions Proximal Distal Covered A / C 55 A / C 75 A / C 95 A / C 55 A / C 75 A / C 95 A / C 80 A / C 100 Flexible Limb Extension Iliac Dimensions Proximal Distal Covered Design I / C 55 F I / C 70 F I / C 88 F I / C 55 F Limb Extensions I S / C 88 F Iliac Dimensions Shape* * Only Proximal present in shaped extensions S = Stepped F = Flared Distal Covered Flexible* * Only present on flexible limb extensions Limb Extension with Spine Proximal Iliac Dimensions Shape Distal Covered I / C 55 I / C 88 I / C 55 I S / C 55 I F / C 65 I S / C 65 Refer to the Instructions For Use for complete and specific prescribing information and all warnings, precautions, and adverse events. Rx only.

8 11 Studebaker Customer Service Irvine, CA Tel Tel Fax AFX and Strata are trademarks of Endologix, Inc. All other trademarks are the property of their respective owners Endologix, Inc. All rights reserved. MM0191 Rev 02