Medtronic plc. · NYSE:MDT
Medtronic — Technical Presentation (March 2025)
28 slides from Medtronic's technical presentation, March 2025
Slide 1: Two-Year Outcomes of the Five-Year SMART Trial
Two-Year Outcomes of the Five-Year SMART Trial SMART Small Annuli Randomized to Evolut or SAPIEN Howard C. Herrmann, MD Roxana Mehran, MD Didier Tchétché, MD on behalf of the SMART Trial Investigators
Slide 2: Disclosure of relevant financial relationships
Disclosure of relevant financial relationships Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below: Financial Relationship Company Institutional grants/research support Abbott Vascular, Edwards LifeSciences,
Slide 3: Background
Background The SMART Trial: Prior Evidence: • Designed to compare performance for 2 most widely available • Hemodynamics of Evolut valve are superior to those of commercial transcatheter aortic valve replacement (TAVR) SAPIEN valve. devices in patients with severe aortic stenosis and a small aortic
Slide 4: SMART Trial Design
SMART Trial Design Prospective, randomized controlled, post-market trial conducted at 83 international sites All-comer trial with all surgical risk categories including bicuspid patients 716 Patients Treated Key eligibility • Symptomatic severe AS* (N=355) • Small aortic annulus (≤430 mm2 by MDCT) R
Slide 5: Baseline characteristics
Baseline characteristics Characteristic Evolut (N=355) SAPIEN (N=361) Age – yr 80.1 ± 6.3 80.3 ± 6.1 Female sex 87.9% 85.6% STS-PROM score – % 3.3 ± 1.9 3.2 ± 1.7 NYHA functional class III/IV 43.4% 39.9% Diabetes 29.3% 34.3% Hypertension 82.5% 86.7% COPD or chronic lung disease 18.0% 17.6% Cerebrova
Slide 6: Valve sizing
Valve sizing Evolut SAPIEN Aortic annulus size (N=355) (N=361) SAPIEN (N=361) Mean area (mm2) 380.9 ± 34.2 382.8 ± 33.9 Mean perimeter (mm) 70.3 ± 3.2 70.4 ± 3.2 Evolut (N=350) SAPIEN (N=365) 78.0% Evolut PRO+ 80.8% SAPIEN 3 Ultra 100% 90.1% Percentage of patients 80% 68.9% Chosen size based on IFU
Slide 7: SMART Trial results at 1 year: Co-primary outcomes
SMART Trial results at 1 year: Co-primary outcomes Mortality, Disabling Stroke, or HF Rehospitalization Bioprosthetic Valve Dysfunction p<0.001 for noninferiority p<0.001 for superiority 20% Difference at 1 year, −1.2% (90% CI −4.9%, 2.5%) Difference, −32.2% (95% CI −38.7%, −25.6%) HR 0.90 (95% CI 0
Slide 8: SMART Trial results at 1 year: Hemodynamics
SMART Trial results at 1 year: Hemodynamics Mean gradient and effective orifice area Mean gradient ≥ 20 mmHg at 1-year visit Effective Orifice Area (cm2) 2.5 50 Mean Gradient (mmHg) 43.8 2.00 50% Percentage of patients 1.96 1.98 Difference, -18.3% (95% CI -23.1%, -13.4%) 2 43.6 40 p<0.001 for superi
Slide 9: Use of SAPIEN valve was a predictor of BVD
Use of SAPIEN valve was a predictor of BVD Finding consistent throughout entire range of annulus area in the trial Incidence of BVD Multivariable predictors of BVD SAPIEN through 1 Year Evolut Overall Cohort Odds Ratio P Value (Evolut + SAPIEN) (95% CI) SAPIEN (vs Evolut) 8.21 <0.001 (5.10-13.23) BS
Slide 10: Results at 2 Years
Results at 2 Years
Slide 11: Population and Follow-up Flowchart
Population and Follow-up Flowchart As-treated Cohort N=716 Evolut SAPIEN N=355 N=361 12 withdrew 6 withdrew 1-Year Follow-Up 1-Year Follow-Up N=343 N=355 6 withdrew 8 withdrew 1 explant 2-Year Follow-Up 2-Year Follow-Up N=335 N=348 2-year follow-up: Data available for 95% of patients Echo compliance
Slide 12: Clinical outcome composite & components through 2 years
Clinical outcome composite & components through 2 years 60% Mortality, Disabling Stroke, or HF Rehospitalization HR 1.01 (95% CI 0.71, 1.43) 50% Log-rank p=0.97 Evolut SAPIEN 2 Years P Value Percentage of patients (N=355) (N=361) 40% All-cause 12.7% 11.4% 0.66 2 years mortality 30% 1 year 17.6% SAPI
Slide 13: Bioprosthetic valve dysfunction through 2 years
Bioprosthetic valve dysfunction through 2 years Difference, -35.9% (95% CI -43.0%, -28.7%) Evolut SAPIEN p<0.001 P Value (N=350) (N=365) 60 BVD composite 12.5% 48.4% <0.001 50 48.4% Percentage of patients HSVD 4.7% 42.4% <0.001 40 NSVD 6.7% 18.0% <0.001 30 Thrombosis (clinical) 0.3% 1.2% 0.17 20 12.
Slide 14: SMART Trial results at 2 years: Hemodynamics
SMART Trial results at 2 years: Hemodynamics Mean gradient ≥ 20mmHg at 2-year visit Mean gradient and effective orifice area 40% Difference -21.4% (95% CI, -26.7%, -16.1%) Percentage of patients 50 p<0.001 for all follow-up time points 2.5 p<0.001 43.8 30% Mean Gradient, mmHg Effective Orifice Area,
Slide 15: Safety events
Safety events 1 Year 2 Years Evolut SAPIEN Log-Rank Evolut SAPIEN Log-Rank KM% (N=355) (N=361) P Value (N=355) (N=361) P Value All-cause mortality 5.1% 5.9% 0.676 12.7% 11.4% 0.657 Cardiovascular mortality 3.4% 3.7% 0.882 7.2% 6.4% 0.706 Aortic valve reintervention 0.9% 0.6% 0.637 0.9% 0.9% 0.978 Ne
Slide 16: Total Aortic Regurgitation
Total Aortic Regurgitation Discharge 30 Days 1 Year 2 Years ≥Mild Total AR 13.3% 5.1% 17.2% 12.7% 14.1% 20.3% 16.7% 19.8% P value P<0.001 P=0.106 P=0.043 P=0.354 100 0.6 5.1 0.3 0.9 1.0 0.8 1.9 12.7 16.9 11.8 14.1 15.9 19.3 17.9 Percentage of patients 80 60 94.9 86.7 82.8 87.3 85.9 83.3 40 79.7 80.2
Slide 17: Alternative valve dysfunction definitions through 2 years
Alternative valve dysfunction definitions through 2 years Alternative definition Evolut SAPIEN Difference P Value Evolut Better SAPIEN Better (Cumulative rates through 2 years) (Superiority _—_— el Mean gradient 220 mmHg 4.7% : -37.7% <0.001 a Individual Mean gradient 222.5 mmHg! 2.6% . -29.9% <0.00
Slide 18: Adverse hemodynamics affect clinical outcomes
Adverse hemodynamics affect clinical outcomes Elevated mean gradient after aortic valve Severe prosthesis-patient mismatch after TAVR replacement reduces survival increases mortality Australian National Echo Registry (6,050 patients with prior aortic valve replacement) Meta-analysis of patient data
Slide 19: Summary
Summary • The randomized SMART trial compared the Evolut and SAPIEN TAVR valves in 716 patients (87% women) with a small aortic annulus. • After 2 years of follow up, we observed similar rates for the clinical outcome composite of death, disabling stroke, and HF hospitalization. • All individual and
Slide 20: Backup
Backup
Slide 21: Prosthetic Valve Thrombosis Through 2 Years
Prosthetic Valve Thrombosis Through 2 Years (CEC adjudicated) Overall (N=18) Clinical (N=5) Subclinical* (N=13) 5.0 P = 0.005 Chart Title P = 0.189 P = 0.013 n=15 4.5 Percentage of patients 4.0 • Death (n=1) 3.5 • MI (n=2) n=11 28% late (30d-1Y) 3.0 • Stroke (n=1) 56% very late (>1Y) • Other (n=1) 2
Slide 22: Total Aortic Regurgitation (paired)
Total Aortic Regurgitation (paired) Discharge 30 Days 1 Year 2 Years ≥Mild Total AR 13.9% 3.4% 17.7% 12.2% 15.2% 18.6% 16.5% 20.7% P value P<0.001 P=0.094 P=0.327 P=0.238 100 0.8 3.4 0.4 0.8 0.4 0.8 2.1 13.1 17.3 11.4 15.2 18.1 15.6 18.6 80 Percentage of patients 60 96.6 86.1 82.3 87.8 84.8 83.5 40
Slide 23: Quality of life
Quality of life KCCQ Overall Summary Score, Mean ± SD VARC-3 KCCQ ordinal outcome at 2 years Evolut vs SAPIEN, p=0.388 66.2% 62.9% 100 Improved Improved 82.2 100% 80.8 80 81.1 Percentage of patients 81.9 Percentage of patients 79.4 80.8 80% 63.0 60 61.4 Substantially Improved 60% Moderately Improved
Slide 24: Thank You to All of Our Patients, Trial Investigators
Trial Leadership/Committees: • Executive Committee Thank You to • Steering Committee • Case Planning Committee All of Our Patients, • Training & Education Committee • Publication Committee Trial Investigators, Independent Safety Committees: • Clinical Events Committee Research Coordinators, • Data S
Slide 25: Definitions
Definitions MG ≥20 (SMART HSVD): Based on SVD, defined as mean gradient ≥20 mmHg at any follow-up echo from discharge through the 2-year study visit MG ≥22.5 (Playford): Based on SVD, defined as mean gradient ≥22.5 mmHg at any follow-up echo from discharge through the 2-year study visit MG ≥25: Base
Slide 26: SMART Trial Clinical Sites
SMART Trial Clinical Sites • The Leeds Teaching Hospitals NHS, Leeds, UK • University of Florida, Gainesville, FL • Morristown Medical Center, Morristown, NJ • Allegheny General Hospital, Pittsburgh, PA • Toronto General Hospital, Toronto, Canada • Los Robles Hospital & Medical Center, Thousand Oaks
Slide 27: Indications
Indications Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure to The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are indicated for relief of aortic stenosis in patients with the vapors. Damage may result
Slide 28: Medtronic contact details
710 Medtronic Parkway LifeLine ©2025 Medtronic. Medtronic, Medtronic logo, and Engineering the Minneapolis, MN 55432-5604 CardioVascular Technical Support extraordinary are trademarks of Medtronic. *Third-party brands USA Toll-free: 877.526.7890 are trademarks of their respective owners. All other b