Edwards SAPIEN 3 Changing the World of Aortic Stenosis Therapy the World of Aortic Stenosis Therapy ... 15 ft. Walk Test > 7s (%) ... PVD 15.8% COPD 21.8% Atrial Fibrillation 16.8%

Edwards SAPIEN 3 Transcatheter Heart Valve

Changing the World of Aortic Stenosis Therapy

Intermediate-Risk Data

The PARTNER II Trial represents the largest, most rigorous

comparative body of evidence in the history of

aortic valve replacement.

Clinical Evidencefor Intermediate-Risk Patients

†The PARTNER II Trial intermediate-risk cohort 30-day unadjusted clinical event rates for TAVI with the SAPIEN 3 valve, AT population (n=1,077). The PARTNER IIA Trial intermediate-risk cohort unadjusted clinical event rates for SAVR, AT population (n=944).

Lower Than Surgery†

Surgical Valve Replacement

SAPIEN 3 TAVI

1.0%

4.4%

Disabling Stroke†

All-cause Mortality†

Surgical Valve Replacement

SAPIEN 3 TAVI

1.1%

4.0%

Thourani V., et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: A propensity score analysis. Lancet. 2016;387: 2218-25.

The PARTNER II Trial

Robust clinical studies with more than 3,000 intermediate-risk patients

Intermediate-Risk Symptomatic Severe Aortic StenosisAssessment by Heart Valve Team

PARTNER II S3i Trial(n=1,078)

PARTNER IIA Trial (n=2,032)

Assessment For Transfemoral Access

Assessment For Optimal Valve Delivery Access YES

Transfemoral (TF)Transapical (TA)/ Transaortic (TAo)

Transfemoral (TF) Transapical (TA)/ Transaortic (TAo)

1:1 Randomization 1:1 Randomization

TF TAVI SAPIEN XT

valve

Surgical AVR

TA/TAo TAVI SAPIEN XT

valve

Surgical AVR

TF TAVI SAPIEN 3 valve

TA/TAo TAVI SAPIEN 3 valve

NO

VS VS

Thourani V., SAPIEN 3 Transcatheter Aortic Valve Replacement Compared with Surgery in Intermediate-Risk Patients: A Propensity Score Analysis. Presented at ACC 2016, April 3, 2016; Chicago, IL.

Baseline Patient Characteristics

As Treated (AT) Population

PARTNER II S3i Trial SAPIEN 3 valve

(n=1,077)

PARTNER IIA Trial Surgery(n=944)

Mean Age (years) 81.9 81.6

Median STS Score (%) 5.2 5.4

CAD (%) 69.6 66.5

Previous CABG (%) 27.9 25.7

Cerebrovascular Disease (%) 9.0 10.3

PVD (%) 28.2 32.2

COPD (%) 30.0 30.2

Cr Level > 2 mg/dL (%) 7.5 5.4

Atrial Fibrillation (%) 36.0 34.9

Permanent Pacemaker (%) 13.2 12.0

15 ft. Walk Test > 7s (%) 41.3 45.7

Thourani V., SAPIEN 3 Transcatheter Aortic Valve Replacement Compared with Surgery in Intermediate-Risk Patients: A Propensity Score Analysis. Presented at ACC 2016, April 3, 2016; Chicago, IL.

All-cause Mortality‡

1.1%

4.0%

All-

cau

se M

ort

alit

y, %

0 3 6 9 12

Months30 days

13.0%

7.4%

40

30

20

10

0

TAVI with SAPIEN 3 valve (PARTNER II S3i Trial)

Surgery (PARTNER IIA Trial)

No. at risk:

Surgery 944 859 836 808 795

SAPIEN 3 TAVI 1,077 1,043 1,017 991 963

TAVI with the SAPIEN 3 valve

demonstrated 75% lower

rates of 30-day all-cause

mortality and disabling

stroke compared to surgery.†

† The PARTNER II Trial intermediate-risk cohort 30-day unadjusted clinical event rates for TAVI with the SAPIEN 3 valve, AT population (n=1,077).

‡ The PARTNER II Trial intermediate-risk cohort unadjusted clinical event rates, AT population.


Disabling Stroke‡

Dis

ablin

g St

roke

, %

0 3 6 9 12 Months

5.9%

2.3%

30 days

4.4%

TAVI with SAPIEN 3 valve (PARTNER II S3i Trial)

Surgery (PARTNER IIA Trial)

40

30

20

10

01.0%

No. at risk:

Surgery 944 825 806 778 764

SAPIEN 3 TAVI 1,077 1,033 1,008 984 953

Edwards Lifesciences data on file

Clinical Events at 30 Days and 1 Year

KM estimates

Other 30-day Clinical Events

Unadjusted Clinical Events (AT) 30 Days 1 Year

Event (%)PARTNER II S3i Trial

SAPIEN 3 valve(n=1,077)


PARTNER II S3i Trial SAPIEN 3 valve

(n=1,077)


All-cause Mortality 1.1 4.0 7.4 13.0

Cardiac Mortality 0.9 3.1 4.5 8.1

All Stroke 2.7 6.1 4.6 8.2

Disabling Stroke 1.0 4.4 2.3 5.9

All-cause Death or Disabling

Stroke2.0 8.0 8.4 16.6

Unadjusted Clinical Events at 30 Days (AT)

Event (%)PARTNER II S3i Trial



Myocardial Infarction 0.3 1.9

Major Vascular Complication 6.1 5.4

AKI (Stage III) 0.5 3.3

Life-threatening/Disabling Bleeding 4.6 46.7

New Atrial Fibrillation 5.0 28.3

New Permanent Pacemaker 10.2 7.3

Endocarditis 0.2 0.0

KM estimatesThourani V., et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: A propensity score analysis. Lancet. 2016;387: 2218-25.

KM estimates for re-hospitalization and re-intervention

Hospital Efficiencies

At 30 DaysPARTNER II S3i Trial



Unadjusted Procedural Factors (AT), Days

Median Hospitalisation 4.0 9.0

Median ICU Stay* 2.0 4.0

Unadjusted Clinical Events (AT) , Event %

Re-hospitalisation 4.6 6.8

Aortic Valve Re-intervention 0.1 0.0


* Edwards Lifesciences data on file

Minimal Paravalvular Regurgitation

§ The PARTNER II Trial intermediate-risk cohort, unadjusted core lab assessed paravalvular leak. Grading of paravalvular regurgitation reduced to the standard classification scheme per Pibarot P, Hahn RT, Weissman NJ, Monaghan MJ. Assessment of paravalvular regurgitation following TAVI: a proposal of unifying grading scheme. JACC Cardiovasc Imaging 2015; 8: 340–60.

0

20

40

60

80

100

% of

Pat

ient

s

30 Days

Severe

Moderate

Mild

None/Trace

PARTNER II S3i TrialSAPIEN 3 valve

PARTNER IIA TrialSurgery

1 Year

PARTNER II S3i TrialSAPIEN 3 valve

PARTNER IIA TrialSurgery

No. of echos:

557 yregruS 610

SAPIEN 3 TAVI 992 875

96.7% 39.8% 95.9%

58.7%

45.0%

51.2%

2.8% 3.8%

0.5% Moderateor Severe




Paravalvular Regurgitation§

1 12 2

1. Thourani V., et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: A propensity score analysis. Lancet. 2016;387: 2218-25.

2. Edwards Lifesciences data on file

Aortic Valve Area and Mean Gradient Following TAVI

0

0.5

1

1.5

2

2.5

0

10

20

30

40

50

60

70

Aor

tic

Val

ve A

rea

(cm

2 )1

Mea

n G

rad

ient

(mm

Hg)

1

Reference: Lancet, Thourani supplement, Appendix Figure 2

Baseline 30 Days 1 Year

N = 1052 N = 1019 N = 900

1015

1048

EOA No. of Patients2

Mean GradientNo. of Patients2

953

1009

806

884

Aortic Valve Area and Mean Gradient Following TAVR

Error bars represent ± one standard deviation

p<0.0001for changefrom baseline

p<0.0001for changefrom baseline

1. Thourani V., et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: A propensity score analysis. Lancet. 2016;387: 2218-25.

2. Edwards Lifesciences data on file

SAPIEN 3 Valve CE Mark Study and PARTNER II Trial

All-Cause Mortality

US S3 Intermediate RiskEU S3 Intermediate Risk

All-

Cau

se M

orta

lity

(%)

Months from ProcedureNumber at RiskUS S3IR 1,077EU S3IR 109

1,017107

991105

96387

1,043107

7.4%

7.3%

0

10

20

30

40

50

126 930

1.1%

0.9%

SAPIEN 3 Valve CE Mark Study and PARTNER II TrialAll-Cause Mortality

Webb J, 1-year outcomes from the SAPIEN 3 Trial. Presented at EuroPCR 2016; May 2016, Paris, France.

Improving Clinical Outcomes Through Valve Innovation

0

5

10

PARTNER IB Trial(Transfemoral)

PARTNER IA Trial(Overall)

PARTNER IIB Trial(Transfemoral)

PARTNER IIB Trial(Transfemoral)

PARTNER II HR Trial(Overall)

PARTNER II S3i Trial(Overall)

All-

caus

e M

orta

lity,

%

SAPIEN Valve

PARTNER I Trial & PARTNER II Trial 30-day Mortality

Inoperable High-risk or greater Intermediate-risk

SAPIEN XT Valve SAPIEN 3 Valve

6.3%

5.2%4.5%

3.5%

2.2%

1.1%

n=175

n=344n=271

n=282

n=583

n=1,077

KM estimates

Kodali S., Clinical and Echocardiographic Outcomes at 30 Days with the SAPIEN 3 TAVR System in Inoperable, High-Risk and Intermediate-Risk AS Patients. Presented at ACC 2015, March 15, 2015; San Diego, California.

SAPIEN 3 Valve CE Mark Trial

Intermediate Risk

Baseline Patient Characteristics, As Treated (AT) Population

SAPIEN 3 Valve CE Mark Trial Transfemoral Cohort (n=101)

Mean Age (years) 84.4 years

STS Score (STS) 5.2 ± 1.7 %

Logistic EuroSCORE 13.2 ± 5.1 %

Previous CABG 10.9%

Prior Stroke 8.9%

PVD 15.8%

COPD 21.8%

Atrial Fibrillation 16.8%

Permanent Pacemaker 6.9%

Webb J., 1-Year Outcomes From the SAPIEN 3 Trial. Presented at EuroPCR 2016, May 17-20, 2016; Paris, France.

Clinical Events at 30 Days and 1 Year

Unadjusted Clinical Events (AT) 30 Days 1 Year

Event (%)SAPIEN 3 Valve CE Mark Trial Transfemoral Cohort (n=101)

All-cause Mortality 1.0% 7.9%

Cardiac Mortality 1.0% 4.0%

All Stroke 3.0% 6.0%

Disabling Stroke 2.0% 5.0%

New-onset Atrial Fibrillation 7.0% 8.0%

Major Vascular Complication 2.0% -

Life-threatening Bleeding 2.0% -

Acute Kidney Injury (II/III) 1.0% -

New Permanent Pacemaker 4.0% 6.4%

KM estimates

Webb J., 1-Year Outcomes From the SAPIEN 3 Trial. Presented at EuroPCR 2016, May 17-20, 2016; Paris, France.

For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions, and adverse events.

Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.

Material for distribution only in countries with applicable health authority product registrations. Material not intended for distribution in USA or Japan. Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device.

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Edwards SAPIEN 3 Changing the World of Aortic Stenosis Therapy the World of Aortic Stenosis Therapy ... 15 ft. Walk Test > 7s (%) ... PVD 15.8% COPD 21.8% Atrial Fibrillation 16.8%