Medtronic Plc. · NYSE:MDT
Medtronic — Technical Presentation (August 2017)
29 slides from Medtronic's technical presentation, August 2017
Slide 1: 5-Year EVAR Outcomes Are Equivalent Between Genders
5-YEAR EVAR OUTCOMES ARE EQUIVALENT BETWEEN GENDERS RESULTS FROM THE ENGAGE REGISTRY MARC SCHERMERHORN, MD BETH ISRAEL DEACONESS MEDICAL CENTER AND HARVARD MEDICAL SCHOOL BOSTON, MA UC201804383IE © 2017 Medtronic. All Rights Reserved. Medtronic, Medtronic logo and Further. Together are Indications,
Slide 2: 5-year EVAR Outcomes Are Equivalent Between Genders
5-year EVAR Outcomes Are Equivalent Between Genders Results from the ENGAGE Registry Marc Schermerhorn, MD Beth Israel Deaconess Medical Center and Harvard Medical School Boston, MA
Slide 3: Disclosure
Disclosure Speaker Name: Marc Schermerhorn X I have the following potential conflicts of interest to report: X Consultant for Abbott, Cook Medical , Endologix and Phillips Receipt of honoraria and travel support Participation in a company sponsored speakers‘ bureau Employment in industry Sha
Slide 4: Then…. Prior studies of gender differences in EVAR
Then…. Prior studies of gender differences in EVAR demonstrate females are more challenging in terms of presentation, suitability, and clinical outcomes
Slide 5: Abdominal aortic aneurysms in women (prior publication)
'E:u:T1V . - : Endov.acsc S..U" :?6, li.9 7 ] : C!COJ) d ci::10..la ; ; J /q'f,,-2012..1U l , v U . a b l e on.liTIL'! .at b .a p : J/ onaa ,awe• @ D •• • aY• A bd o m inal ao rtic a neu rys1n s in w om en A.l,dQm i1: u l a o r t i c a uys111 ( A A A ) l u s 1',,ng: bee s, r c o l ) d u • condit:i1,
Slide 6: Now… Early data from ENGAGE shows no early differences
Now… Early data from ENGAGE shows no early differences Do gender differences really exist with new generation devices?
Slide 7: Scientific Question
Scientific Question Are long-term (5 years) gender differences observed with the Endurant Stent Graft?
Slide 8: The ENGAGE Registry
The ENGAGE Registry Largest Contemporary EVAR Registry with single manufacturer's stent graft: ENDURANT 1263 Patients 30 Countries 6 Continents Real world patients: Limited inclusion/exclusion criteria Real world practice: Canada (N=120) Southern Europe (N=182) Asia (N=62) Limited procedural s
Slide 9: The ENGAGE Registry
The ENGAGE Registry Follow-up: Patients Consecutively Enrolled 30-day, Annual Visits Through 10 Years Extensive Monitoring On-going 100% Data Independent Data Independent Management Monitoring Clinical Review (100% Endpoints) Event Committee High Quality Data
Slide 10: ENGAGE – Baseline Characteristics
ENGAGE – Baseline Characteristics Male Female (N) (N) Baseline Characteristic Male Female p-Value (mean±SD) (N = 1130) (N = 133) 1130 133 Age (yrs) 72.8±8.1 75.7±7.1 <0.001 Max. Aneurysm Dia. (mm) 60.6±11.8 57.9±9.6 0.012 89.5% 10.5% Prox. Neck Dia (mm) 23.9 ±3.5 21.8±3.3 <0.001 Distal Neck Dia. (mm
Slide 11: ENGAGE – Baseline Characteristics
ENGAGE – Baseline Characteristics Baseline Characteristic Male Female p-Value (mean±SD) (N = 1130) (N = 133) Proximal Neck Length (mm) 27.3±12.4 24.5±11.9 0.014 Prox. Neck Length – Prox. Neck Length – Male Female 11.5% 16.5% 88.5% 83.5% P-Value = 0.088 <15mm >15mm <15mm >15mm
Slide 12: ENGAGE – Baseline Characteristics
ENGAGE – Baseline Characteristics Baseline Characteristic Male Female p-Value (mean±SD) (N = 1130) (N = 133) Infrarenal Neck Angle (deg) 29.4±23.3 38.1±26.2 <0.001 Infrarenal Neck Angle Infrarenal Neck Angle > 60˚ - Male > 60˚ - Female 9.0% 19.7% 91.0% 80.3% P-Value = <0.001 >60 deg. <60 deg. >60 de
Slide 13: ENGAGE – Baseline Risk Factors
ENGAGE – Baseline Risk Factors Risk Factor Male Female p-Value (N = 1130) (N = 133) Tobacco Use 50.1% 42,4% 0.094 Hypertension 75.1% 78,2% 0.435 Hyperlipidemia 60.1% 64.8% 0.297 Diabetes 18.8% 21,1% 0.531 Cardiac Disease 54.7% 45.1% 0.035 Coronary Artery Disease 36.4% 21.4% <0.001 Cardiac Revas. (In
Slide 14: ENGAGE – Procedure Information
ENGAGE – Procedure Information Measurement Male Female p-Value (Mean±SD) (N = 1130) (N = 133) Duration of Implant Procedure 99.7±44.5 97.4±48.9 0.580 (min) Hospital Stay (Days) 6.4±6.1 7.9±9.8 0.017 Duration of ICU (Hours) 10.4±44.6 7.7±18.2 0.312 Successful Delivery and 99.5% 99.2% 0.746 Deployment
Slide 15: Subjects Implanted Outside of IFU
Subjects Implanted Outside of IFU Subjects Implanted Male Female p-Value Outside of IFU (N = 1130) (N = 133) 16.1% 32.3% <0.001 20.0% 18.0% 17.3% 16.0% 14.0% 12.0% 10.0% 8.3% 8.0% 6.0% 4.3% 4.3% 4.5% 4.0% 2.0% 1.9% 0.0% Prox. Neck Dia. Outside of Prox. Neck Length >=15mm; Proximal Neck Length 19-32
Slide 16: 5 Year Freedom From All-Cause Mortality
5 Year Freedom From All-Cause Mortality Male: FF From ACM = 67.5% Female: FF From ACM = 65.6% p-Value = 0.8735 Male Female 0-30D 31D – 1Y 1Y – 2Y 2Y – 3Y 3Y – 4Y 4Y – 5Y 0-30D 31D – 1Y 1Y – 2Y 2Y – 3Y 3Y – 4Y 4Y – 5Y No. at Risk1 1130 1110 1032 893 803 703 133 133 118 105 90 76
Slide 17: 5 Year Freedom From Aneurysm-Related Mortality
5 Year Freedom From Aneurysm-Related Mortality Male: FF From ARM = 97.5% Female: FF From ARM = 100.0% p-Value = 0.0881 No Aneurysm-Related Mortality Through 5yrs for Females Male Female 0-30D 31D -1Y 1Y – 2Y 2Y – 3Y 3Y – 4Y 4Y – 5Y 0-30D 31D- 1Y 1Y – 2Y 2Y – 3Y 3Y – 4Y 4Y – 5Y No. at Risk1 1130 1110
Slide 18: 5 Year Freedom From Rupture
5 Year Freedom From Rupture Male: FF From Rupture = 98.4% Female: FF From Rupture = 100.0% p-Value = 0.2263 No Ruptures Through 5yrs for Females Male Female 0-30D 31D – 1Y 1Y – 2Y 2Y – 3Y 3Y – 4Y 4Y – 5Y 0-30D 31D – 1Y 1Y – 2Y 2Y – 3Y 3Y – 4Y 4T – 5Y No. at Risk1 1130 1110 1031 892 801 699 133 133 1
Slide 19: 5 Year Freedom From Conversion
5 Year Freedom From Conversion Male: FF From Conversion = 97.8% Female: FF From Conversion = 99.2% p-Value = 0.4818 Only 1 Conversion Through 5yrs for Females Male Female 0-30D 31D – 1Y 1Y – 2Y 2Y – 3Y 3Y – 4Y 4Y – 5Y 0-30D 31D – 1Y 1Y -2Y 2Y - 3Y 3Y - 4Y 4Y - 5Y No. at Risk1 1130 1108 1032 893 803
Slide 20: Neck Stabilization Markers – Type Ia Endoleak
Neck Stabilization Markers – Type Ia Endoleak Type 1a Male Female p-Value Endoleak At 1 Year 0.2% (2/933) 1.0% (1/101) 0.266 At 2 Year 0.4% (3/768) 1.1% (1/88) 0.353 At 3 Year 0.6% (4/632) 1.4% (1/73) 0.422 At 4 Year 0.7% (4/559) 0.0% (0/55) >0.999 At 5 Year 1.3% (6/449) 3.8% (2/52) 0.197 Low Type 1
Slide 21: 5 Year Freedom From Secondary Procedures
5 Year Freedom From Secondary Procedures Male: FF From Secondary Procedures = 84.1% Female: FF From Secondary Procedures = 85.6% p-Value = 0.5150 No Increased Risk of 2nd Procedures Through 5yrs for Females Male Female 0-30D 31D – 1Y 1Y – 2Y 2Y – 3Y 3Y – 4Y 4Y – 5Y 0-30D 31D – 1Y 1Y – 2Y 2Y – 3Y 3Y
Slide 22: AAA Sac Diameter Changes At 5 Years
AAA Sac Diameter Changes At 5 Years 89.4% Stable or Decrease 89.6% Stable or Decrease Male Female 10.6% 10.4% 28.6% 22.9% 60.8% 66.7% AAA Dia. Increase AAA Dia. Increase AAA Dia. Stable AAA Dia. Stable AAA Diameter Decrease AAA Dia. Decrease AAA Sac Dynamics Equivalent Between Genders
Slide 23: Summary
Summary • Women were older and had less diagnosed cardiac disease • Women had shorter and more angulated necks, smaller iliacs • Women were more commonly treated outside of the Endurant Instructions for Use
Slide 24: Conclusion
Conclusion • With more challenging baseline characteristics and anatomy, women were treated more often outside IFU • Despite these challenges, 5-year long-term outcomes were equivalent between the genders when treated with the Endurant Stent Graft • Endurant sets a new benchmark for EVAR by demonstr
Slide 25: Endurant Stent Graft System Brief Statement
ENDURANT™ STENT GRAFT SYSTEM BRIEF STATEMENT Brief Statement Indications The Endurant™ Stent Graft System is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms in patients with the following characteristics: ▪ Adequate iliac/femoral access that is compat
Slide 26: Endurant Stent Graft System Brief Statement
ENDURANT™ STENT GRAFT SYSTEM BRIEF STATEMENT MRI Safety and Compatibility: Non-clinical testing has demonstrated that the Endurant Stent Graft is MR Conditional. It can be scanned safely in both 1.5T & 3.0T MR systems under certain conditions as described in the product Instructions for Use. For add
Slide 27: Endurant II / Endurant IIs Stent Graft System
ENDURANT™ II/ ENDURANT™ IIS STENT GRAFT SYSTEM Indications The Endurant™ II/Endurant™ IIs bifurcated stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms. The Endurant II aorto-uni-iliac (AUI) stent graft is indicated for the endovascular tr
Slide 28: Endurant II / Endurant IIs Stent Graft System
ENDURANT™ II/ ENDURANT™ IIS STENT GRAFT SYSTEM MRI Safety and Compatibility: Non-clinical testing has demonstrated that the Endurant II/Endurant IIs Stent Graft is MR Conditional. It can be scanned safely in both 1.5T & 3.0T MR systems under certain conditions as described in the product Instruction
Slide 29: www.aortic.medtronicendovascular.com/international
www.aortic.medtronicendovascular.com/international UC201804383IE © 2017 Medtronic. All Rights Reserved. Medtronic, Medtronic logo and Further. Together are 29 trademarks of Medtronic Company. All other brands are trademarks of a Medtronic company. Not for distribution in France or Japan. 08/17