Medtronic Structural Heart Analyst and Investor Briefing
Discussion of the SMART Trial Data
ACC.2024 | Atlanta, GA | April 7, 2024
Forward-looking statements
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties, including risks related to competitive factors, difficulties and delays inherent in the development, manufacturing, marketing and sale of medical products, government regulation, geopolitical conflicts, general economic conditions, and other risks and uncertainties described in the company's periodic reports on file with the U.S. Securities and Exchange Commission including the most recent Annual Report on Form 10-K of the company. Actual results may differ materially from anticipated results. Medtronic does not undertake to update its forward-looking statements or any of the information contained in this presentation, including to reflect future events or circumstances.
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Today's agenda
01 Opening Remarks
- SMART Trial Introduction
- 1-Year SMART Trial Results
- Closing
- Panel Q&A
Ryan Weispfenning Geoff Martha
Nina Goodheart
Dr. Jeffrey Popma
Sean Salmon
All
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Establishing track record of consistency and driving durable growth
Data-driven momentum is building for Structural Heart franchise
Leading positions across large secular growth markets amplified by new product cycles
Innovation and evidence generation positions Medtronic to take share in high growth TAVR market
Executing on commitments and focused on delivering strong shareholder returns
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SMART Trial | A clear win for Medtronic
Structural Heart poised to deliver strong growth with product launches and superior clinical data
All primary and prespecified secondary endpoints met
• Superiority in coprimary valve performance endpoint
• Superiority in all powered secondary endpoints
• Numerically better, non-inferiorin coprimary clinical endpoint
Simultaneous publication in The New England Journal of Medicine
First head-to-head TAVR RCT with intentional focus on women that answers valve selection question for small annulus patients and solidifies valve performance leadership
1-yrdata is critically meaningful because early valve performance (BVD) is associated with a 50% increase in mortality and rehospitalization1
Small annulus TAVR market
40% of total WW TAVR market
35% of EW's US TAVR valves
Additional opportunities
across multiple TAVR populations (women, Asian-descent,valve-in-valve)
Strong cadence of MDT product launches and clinical data are growth catalysts in $6B WW TAVR market growing high-single to low-double digits
Evolut FX+ full US market release anticipated Summer 2024 Continued Evolut FX launch in Japan and Western Europe
Evolut Low Risk Trial 4-yeardata demonstrated TAVR outperformed surgery with sustained valve performance2 and proved cost-effectivenessof Evolut TAVR versus SAVR3
Decade of durability data from NOTION Trial, showing continued benefit of CoreValve platform vs. gold-standard surgical arm4
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Evolut FX+
TAVR System
now FDA
approved
Valve Design | Importance of valve design proven in head-to-head SMART Trial
Highly anticipated trial proves not all TAVR platforms are built the same
Implanters have asked for a direct comparison of two most used TAVR valves
Evolut TAVR System
Supra-annular | Self-expanding
Trial Details
Small annulus as defined by ≤ 430 mm2 by MDCT
Prospective, multi-center, international, randomized controlled trial
83 sites in Canada, EMEA, and United States
716 patients 1:1 Randomization stratified by sex
30-day and annual follow-ups for patients out to 5-Yrs
SAPIEN * TAVR System
Intra-annular | Balloon-expandable
The SMall Annuli Randomized To Evolut or SAPIEN Trial, or SMART Trial, studies how fundamental valve design
differences affect treatment of symptomatic, severe aortic stenosis in patients with small aortic annuli.5
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Bioprosthetic Valve Dysfunction (BVD) portends death and rehospitalization
Aortic Valve Replacement (AVR) patients want great valve performance for their lifetime
Four categories of "Bioprosthetic Valve Dysfunction"
Structural Valve
Deterioration
Occurs Years
After AVR
Non-Structural
Valve Dysfunction
Occurs Immediately After
AVR
Thrombosis
Occurs Unpredictably
Anytime After AVR
Endocarditis
Occurs Unpredictably
Anytime After AVR
Valve becomes calcified, damaged,
or otherwise not functioning
correctly
Valve is not damaged, but the
orifice is not large enough to permit sufficient blood flow for the patient or is leaking around the edge
Blood clots form on the leaflets that restrict movement and blood flow
Bacterial infection of the bioprosthetic valve leaflets
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Bioprosthetic Valve Dysfunction (BVD) leads to death and rehospitalization
Each component of BVD portends an adverse outcome
Four categories of "Bioprosthetic Valve Dysfunction"
Structural Valve
Deterioration
Occurs Years
After AVR
Non-Structural
Valve Dysfunction
Occurs Immediately After
AVR
Thrombosis
Occurs Unpredictably
Anytime After AVR
Endocarditis
Occurs Unpredictably
Anytime After AVR
18
19
20
21
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Poor valve performance causes an increase in 5-year hard clinical endpoints
Structural Valve Deterioration (SVD) occurs later
SVD Cumulative Incidence | SVD Predicts 5-Year Mortality |
Curves separating
later ~3yrs mark
When SVD occurs, it is associated with6
100%
5-YR rate of
DEATH
CV DEATH
REHOSPITALIZATION
COMPOSITE
9 | ACC.24 Structural Heart Analyst and Investor Briefing | April 7, 2024
Poor valve performance causes an increase in 5-year hard clinical endpoints
BVD occurs earlier with curves separating starting at 30 days
BVD Cumulative Incidence | BVD Predicts 5-Year Mortality |
Curves start
separating at 30 days
The presence of BVD is associated with1
50%
5-YR rate of
DEATH
CV DEATH
REHOSPITALIZATION
COMPOSITE
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Medtronic plc published this content on 07 April 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 April 2024 05:47:04 UTC.