Slide 1: Endurant delivers sac regression with long-term outcomes
Endurant™ delivers sac regression with long-term outcomes The New Standard of EVAR Durability
Slide 2: Evidence links sac regression to better long-term survival
Evidence1 links sac regression to better long-term survival Endurant patients survival at 10 years from intervention1 Paradigm shift Clinical success Design Conclusions 14,817 Survival at 10 Yrs: Regression group: 78% total subjects in VQI (Vascular Quality Initiative) Stable group: 69%† subjected t
Slide 3: ENGAGE OUS Registry confirms sac regression link to improved outcomes
ENGAGE OUS Registry confirms sac regression link to improved outcomes1 Endurant patients survival and freedom from secondary re-intervention at 5 years1 Paradigm shift Clinical success Design Conclusions 949 Patients with 1mo and 1yr imaging (ENGAGE OUS Registry) Freedom from all cause mortality Fre
Slide 4: Endurant stent graft system delivers durability with sac regression
Endurant™ stent graft system delivers durability with sac regression Endurant patients show consistent and high sac regression from 3 - 8 years in Real-World ENGAGE OUS Registry1 Paradigm shift Clinical success Design Conclusions ENGAGE Cohort ENGAGE Extended Cohort 4.8% 10.5% 11.5% 12.8% 14.9% 14.6
Slide 5: Freedom from All Cause Mortality
Endurant™ demonstrates continued durable outcomes Endurant™ patients with sac regression demonstrate significantly lower all-cause mortality1 Paradigm shift Clinical success Design Conclusions 100% ENGAGE Cohort ENGAGE Extended Cohort All Cause Mortality 90% Freedom from 80% 70% 60% FF ACM through 8
Slide 6: Any Secondary Procedures
Endurant™ demonstrates continued durable outcomes Patients with sac regression demonstrate significantly lower secondary procedures1 Paradigm shift Clinical success Design Conclusions 100% ENGAGE Cohort ENGAGE Extended Cohort Reasons* for secondary endovascular Any Secondary Procedures procedures th
Slide 7: Freedom from any Endoleak
Endurant™ demonstrates continued durable outcomes Patients with sac regression demonstrate significantly lower endoleaks1 Paradigm shift Clinical success Design Conclusions 100% ENGAGE Cohort ENGAGE Extended Cohort Freedom from any Endoleak 90% 80% 70% 60% FF Any Endoleak through 8 years 50% Decreas
Slide 8: Sac regression with Endurant at 1Y is an indicator for high sac regression at 8Y
Sac regression with Endurant™ at 1Y is an indicator for high sac regression at 8Y 84% of Endurant patients who had sac regression at one year and had available images at 8Y demonstrated persistent sac regression1 Paradigm shift Clinical success Design Conclusions 100% 4.8% (46/949) 80% 24% 28% 48% (
Slide 9: The drivers of sac regression are multifactorial
The drivers of sac regression are multifactorial.2 Case study Paradigm shift Clinical success Design Conclusions Stent graft design + Patient + Procedural & post- + Stent graft design affects sac factors operative factors factors regression2 Pre op (86mm) 1-year post op (49mm) 5-years post op (39mm)
Slide 10: The drivers of sac regression are multifactorial
The drivers of sac regression are multifactorial.2 Case study Paradigm shift Clinical success Design Conclusions Stent graft design + Patient + Procedural & post- + Stent graft design affects sac factors operative factors factors regression2 • Demographics • Treatment medications • Co-morbidities •
Slide 11: The drivers of sac regression are multifactorial
The drivers of sac regression are multifactorial.2 Case study Paradigm shift Clinical success Design Conclusions Stent graft design affects sac + Patient + Procedural & post- + Stent graft design factors operative factors factors regression2 • Imaging quality • Complications • Re-interventions • End
Slide 12: The drivers of sac regression are multifactorial
The drivers of sac regression are multifactorial.2 Case study Paradigm shift Clinical success Design Conclusions Stent graft design + Patient + Procedural & post- + Stent graft design affects sac factors operative factors factors regression2 • Pre-case planning • Graft of choice • Graft design Pre o
Slide 13: ADVANCE Trial
You’re invested. So are we. Aortic support where and when it matters | Technical expertise | Robust aortic clinical evidence Paradigm shift Clinical success Design Conclusions ADVANCE Trial EndurAnt Stent Graft system vs ExcluDer endoprothesis: a global, prospectiVe, rANdomized Clinical trial in sac
Slide 14: The Effect of EndoAnchors on Aneurysm Sac Regression
The Effect of EndoAnchors on Aneurysm Sac Regression for Patients Treated With Infrarenal Endovascular Repair With Hostile Neck Anatomies: A Propensity Scored Analysis Paradigm shift Clinical success Design Conclusions To analyze sac evolution patterns in matched patients with hostile seal zone anat
Slide 15: The Effect of EndoAnchors on Aneurysm Sac Regression: outcomes
The Effect of EndoAnchors on Aneurysm Sac Regression for Patients Treated With Infrarenal Endovascular Repair With Hostile Neck Anatomies: A Propensity Scored Analysis Paradigm shift Clinical success Design Conclusions Outcomes ESAR group sEVAR group ESAR provided Sac regression achievement (> 5mm)
Slide 16: Endurant II/IIs Stent graft system
A design that addresses sac regression Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Endurant II/IIs Stent graft system 16
Slide 17: Accurate placement, continuous seal, resistance against type II endoleaks
A design that addresses sac regression Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions + Accurate placement & controlled deployment + Continuous seal, fixation & graft conformability + Resistance against type II Els and
Slide 18: Endurant has a design that achieves durable sac regression
Endurant™ has a design that achieves durable sac regression1,2 Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Tip capture Endurant™ IDE study N=150 Accurate deployment 99.3% • Maximize seal length deployment • Secure f
Slide 19: A design that addresses sac regression
A design that addresses sac regression Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Continuous seal, fixation and graft conformability Design + M-shaped proximal stents • See the benchtop data + + Suprarenal stent an
Slide 20: A design that addresses sac regression
A design that addresses sac regression Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Continuous seal, fixation and graft conformability Design + M-shaped proximal stents • See the benchtop data + + Suprarenal stent an
Slide 21: Proximal seal is critical to decreasing aneurysm sac pressure
Proximal seal is critical to decreasing aneurysm sac pressure1 The decreased pressure on the aneurysm reduces the risk of rupture1 Paradigm shift Clinical success Design Conclusions What is the critical factor for depressurizing the aneurysm? Proximal seal Type Ia endoleak transmits the highest pres
Slide 22: Endurant design addresses sac regression with durable outcomes
Endurant™ design addresses sac regression with durable outcomes Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions M-shaped proximal stent Continuous seal, fixation and graft conformability • Maximum wall apposition Low ty
Slide 23: M-shaped proximal stent enables continuous seal, fixation and conformability
M-shaped proximal stent enables continuous seal, fixation and graft conformability Bench test conducted to understand how proximal seal zone with Endurant™ performs in a dynamic environment Paradigm shift Clinical success Design Conclusions M-shaped proximal stent - Methodology • Independent lab • T
Slide 24: Endurant has a design that achieves durable sac regression
Endurant ™ has a design that achieves durable sac regression 1,2 Continuous seal, fixation and graft conformability Paradigm shift Clinical success Design Conclusions Results: M-stent maintains even distribution of contact pressure in a pulsatile environment VIEW Normalized Contact Pressure in Systo
Slide 25: Z-stent unevenly distributes contact pressure across the seal zone
Latest insights Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Results: Z-stent unevenly distributes contact pressure across the seal zone VIEW Normalized Contact Pressure in Systole (120mmHg)† (Z-stent) VIEW Z-STENT Z-STENT Seal Zone
Slide 26: M-stent evenly distributes contact pressure across the seal zone
Latest insights Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Bench test results A design that addresses sac regression Continuous seal, fixation and graft conformability Results: M-stent evenly distributes contact pressure across the
Slide 27: M-stent maintains even distribution of contact pressure
Latest insights Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Bench test results A design that addresses sac regression Continuous seal, fixation and graft conformability Results: M-stent maintains even distribution of contact pressur
Slide 28: What about the endoleaks we can't see or definitively diagnose?
What about the endoleaks we can’t see or definitively diagnose? Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Dynamic aorta demands continuous seal Cardiac cycle and posture can cause subtle interruption in the aorta-graft seal that m
Slide 29: A design that addresses sac regression
A design that addresses sac regression Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Continuous seal, fixation and graft conformability Design + M-shaped proximal stents • See the benchtop data + + Suprarenal stent an
Slide 30: Suprarenal fixation and low main body migration rates
Endurant™ has a design that achieves durable sac regression1,2 Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Suprarenal fixation • Enhances graft conformability in angulated anatomy • Separates fixation from seal Low
Slide 31: A design that addresses sac regression
A design that addresses sac regression Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Resistance against type II Els & Durable hemostatic barrier Design Multifilament polyester material Benefit Provides resistance agai
Slide 32: Graft material choice impacts sac dynamics and Type II endoleak rates
A design that addresses sac regression Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Resistance against type II Els & Durable hemostatic barrier Graft material choice impacts sac dynamics and Type II endoleak rates. P
Slide 33: Do type II endoleaks influence sac regression?
Do type II endoleaks influence sac regression? Endurant™ delivers durability with sac regression and reduced type II endoleaks at 1 year1 Paradigm shift Clinical success Design Conclusions Sac regression Type II endoleaks 48% 37% 27% 9% U.S. Endurant Excluder™* U.S. Endurant Excluder™* IDE (Bifur) 1
Slide 34: Subset of type II endoleaks indicate occult type I endoleaks
Subset of type II endoleaks indicate occult type I endoleaks1,2,3 Occult endoleaks diagnosed as type II can lead to treatment failure1,2,3 Paradigm shift Clinical success Design Conclusions Type II endoleaks may be a risk factor for sac increase 1. Abdulhameed Aziz, MD, et al. Outcomes of percutaneo
Slide 35: Endurant delivers durability with sac regression and long-term outcomes
Endurant™ Conclusions delivers durability with sac regression 1 2 and long-term The real-world ENGAGE OUS The stent-graft design is one of outcomes Registry data confirms VQI data many factors that may affect sac and shows sac regression is regression. associated with improved long- term survival an
Slide 36: Is EVAR undergoing a Paradigm Shift?
Is EVAR undergoing a Paradigm Shift? Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions New evidence1 links sac regression to better long-term survival - VQI analysis is relevant to real-world EVAR patient outcomes: • 30,0
Slide 37: Is EVAR undergoing a Paradigm Shift?
Is EVAR undergoing a Paradigm Shift? Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions New evidence1 links sac regression to better long-term survival Sac dynamics have always been a robust indicator of EVAR durability bu
Slide 38: Is EVAR undergoing a Paradigm Shift?
Is EVAR undergoing a Paradigm Shift? Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions New evidence1 links sac regression to better long-term survival - 1. O’Donnell TFX, Deery SE, Boitano LT, et al. Aneurysm sac failure
Slide 39: How is Link confirmed with other data sets?
How is Link confirmed with other data sets? Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Engage ous registry confirms sac regression link to long-term outcomes1 - 1. Bӧckler D, Li C, Dansey K, et al. Sac regression i
Slide 40: How do patients with sac regression at 1 year progress?
How do patients with sac regression at 1 year progress? Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions 86% of patients with sac regression at 1Y are still regressing at 5y1 - 1. Bӧckler D, Li C, Dansey K, et al. Sac re
Slide 41: Intentional Design drives clinical success in sac regression
Intentional Design drives clinical success in sac regression Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Excellent outcomes in straight forward and complex patients - † Sac regression defined as the reduction in max
Slide 42: Technology can further optimize EVAR outcomes
Technology can FURTHER optimize EVAR outcomes – including sac regression Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions The Endurant™ II/IIs STENT GRAFT system with ESAR elevates EVAR design elements to be more like OS
Slide 43: Is EVAR undergoing a Paradigm Shift?
Is EVAR undergoing a Paradigm Shift? Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions - 1. O’Donnell TFX, Deery SE, Boitano LT, et al. Aneurysm sac failure to regress after endovascular aneurysm repair is associated with
Slide 44: A design that addresses sac regression
A design that addresses sac regression Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Accurate placement & controlled deployment - FS156 Acute Evaluation of Medtronic Vascular’s Endurant Stent Graft System in an Ovine
Slide 45: A design that addresses sac regression
A design that addresses sac regression Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Accurate placement & controlled deployment - Delivery success = successful vascular access and delivery of the device to the intende
Slide 46: A design that addresses sac regression
A design that addresses sac regression Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Continuous seal, fixation and graft conformability - Stokmans RA, Teijink JA, Forbes TL, et al. Early results from the ENGAGE regist
Slide 47: A design that addresses sac regression
A design that addresses sac regression Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Continuous seal, fixation and graft conformability - 'M-shaped proximal stent provides wall apposition and minimize in-folding. Supr
Slide 48: A design that addresses sac regression
A design that addresses sac regression Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Continuous seal, fixation and graft conformability - ENGAGE OUS Registry: Medtronic data on file. R.A. Stokmans, et al. European Jou
Slide 49: A design that addresses sac regression
A design that addresses sac regression Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Continuous seal, fixation and graft conformability - D00339012 - Infrarenal Seal Zone Characterization Test Report. 49
Slide 50: A design that addresses sac regression
A design that addresses sac regression Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Resistance against type II ELS & durable hemostatic barrier - DVR 7245 Endurant Design Verification Report - Sec. 9.10 Stent Graft P
Slide 51: A design that addresses sac regression
A design that addresses sac regression Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Resistance against type II ELS & durable hemostatic barrier - Published IDE data show clinical outcomes that differ between those th
Slide 52: A design that addresses sac regression
A design that addresses sac regression Latest insights: Significance of Sac regression and drivers for EVAR outcomes Paradigm shift Clinical success Design Conclusions Resistance against type II ELS & durable hemostatic barrier See the device manual for detailed information regarding the instruction