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Structural Heart Investor Update

EuroPCR

May 16, 2017

Kevin Ballinger

Executive Vice President and President, Interventional Cardiology

Prof. Ian Meredith, AM

Executive Vice President and Global Chief Medical Officer

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Safe Harbor for Forward-Looking Statements

This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could differ materially from the expectations and projections expressed or implied by our forward-looking statements.

Factors that may cause such differences can be found in our most recent Form 10-K and Forms 10-Q filed or to be filed with the Securities and Exchange Commission under the headings “Risk Factors” and “Safe Harbor for Forward-Looking Statements.” Accordingly, you are cautioned not to place undue reliance on any of our forward-looking statements. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which they may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.

3 *CE Marked. Not available for use or sale in the U.S.

**Not available for use or sale.

IC Category Leadership – Breadth of Portfolio

*

**

TRANSFEMORAL TAVI SYSTEM

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LOTUS™ Valve Platform

Complete Control

ACURATE™

Valve Platform

Simplifying TAVI

Mechanically expanding platform designed for:

• Full repositioning and retrievability

• Precise placement & freedom from PVL

• Predictable results

Self expanding platform with:

• Intuitive implantation

• Precise placement & low PPM

• Flexible delivery system

More Control for Each Patient

Unique and Compelling TAVR Portfolio Offering Investing for leadership

PVL = paravalvular leak; PPM = permanent pacemaker

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REPRISE III Trial Design and Methods

First global head-to-head TAVR pivotal study

Heart Team assessment Case Review Committee confirmation

‡ Performed by a neurologist, neurology fellow, neurology physician assistant, or neurology nurse practitioner.

Neurologist examination‡

Neurologist examination‡

Randomised 2:1 (Lotus : CoreValve): 55 centres, 912 patients

Severe aortic stenosis; extreme or high operative risk; transfemoral access

Lotus Valve (23, 25 & 27mm) Mechanically expanded

Repositioning/retrieval in final position Seal to minimise paravalvular leak

CoreValve (26, 29 & 31mm) Commercially available

Self-expanding CoreValve Classic / CoreValve Evolut R

Clinical & Echocardiographic f/u: Discharge or 7d, 30d, 6m, annually 1-5y

Primary Safety Endpoint (30 days): Composite of all-cause death, stroke, major vascular complications, life-threatening/major bleed, & stage 2/3 acute kidney injury

Primary Effectiveness Endpoint (1 year): Composite of all-cause death, disabling stroke & moderate or greater paravalvular leak (core lab assessment)

Independent Analyses: Clinical Events Committee, Core Labs, Independent Data Validation

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◦

◦

◦

Feldman, EuroPCR 2017.

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% P

erc

en

tag

e o

f P

atien

ts 13.5

7.1

11.1 11.9

3.6

2.0

0

5

10

15 Primary Effectiveness Endpoint Components BSC (N = 607)

MDT (N = 305)

P = 0.51

All Cause Mortality* Disabling Stroke* Moderate / > PVL*

P = 0.02 P < 0.001

*Component of the primary effectiveness endpoint ^All patients had a neurologic exam conducted by a neurology professional at baseline, discharge, 1 year, and after

any suspected stroke. All patients also had NIHSS at discharge and 1 year and mRS at baseline and all f/u time points. Event rates based on intent to treat results.

LOTUS™ Valve Primary Effectiveness Endpoint:

Superiority at 1 Year to CoreValve Platform

LOTUS Valve Composite = 16.7% vs. CoreValve Platform Composite = 29.0%

Superiority P < 0.001

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LOTUS Valve = 3.6% vs. CoreValve Platform = 7.3%

P = 0.02

Disabling Stroke

1-Year

Dis

ab

ling

Str

oke

%

Lotus

CoreValve

LOTUS™ Valve:

Significantly Lower Disabling Stroke at 1 Year

8

11.1

2.0

0

5

10

15

Superior PVL Performance Significantly Lower

≥ Moderate PVL Rates

% P

atie

nts

Superior Procedural Outcomes Significantly Lower TAV in TAV and

Valve Malpositioning

≥ Moderate PVL

Superiority P < 0.001

CoreValve (N = 216)

LOTUS Valve (N = 216)

* There were no cases of severe PVL (grading per Pibarot, et al. , JACC Img 2015;8:340) ± For superiority testing, echocardiograms with less than moderate total aortic regurgitation and visible PVL that was not gradable were included in the group with less than moderate PVL. For reporting of all PVL, only echocardiograms with gradable PVL were included.

LOTUS™ Valve: Significantly Lower PVL +

Zero Valve-in-Valve and Zero Malpositioning

3.0

0.0 0

1

2

3

4

5

TAV in TAV

Procedural Events

BSC

P < 0.001

MDT

% P

atie

nts

2.6

0.0 0

1

2

3

4

5

Valve Malpositioning

P < 0.001

% P

atie

nts

0% TAV in TAV 0% Valve

Malpositioning

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Permanent pacemaker implanted 30 Day (N=994) 1 Year (N=983) among all patients 8.2% 10.0%

Moellmann, EuroPCR 2017.

SAVI TF 1000: Prospective, single arm, multicenter post-market study of 1,000

patients at 25 centers with the ACURATE neo™ Valve

Acurate neo™ SAVI TF Registry: Excellent outcomes, very low PPM rates

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Watchman™ LAAC EWOLUTION All-Comers Study: Reduction in Ischemic Stroke and Major Bleeding

7.2%

1.1%

0%

2%

4%

6%

8%

10%

12%

Ischemic Stroke

Expected, based onCHA2DS2-VASc*

Observed inEWOLUTION

RR

84%

*Effectiveness in stroke reduction vs. estimated in the absence of therapy for comparable CHA2DS2-VASc scores based on Friberg et al. EHJ 2012

**Effectiveness in bleeding reduction vs. estimated under VKA therapy for comparable HAS-BLED scores based on Lip et al. JACC 2011

5.0%

2.3%

0%

2%

4%

6%

8%

10%

12%

Major Bleeding Excl. Procedural

Expected, based onHAS-BLED**

Observed inEWOLUTION

RR

54%

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EuroPCR 2017 Key Data Releases

May 16

• (LBCT) A prospective, randomized investigation of a novel TAVI system: the REPRISE III trial

• (LBCT) Real-world experience using a 2nd generation self-expanding prosthesis: 1-year outcomes of 1000 patients enrolled in the SAVI-TF registry

• (LBCT) The RESPOND study at one-year: primary endpoint outcomes with a repositionable and fully retrievable aortic valve in routine clinical practice

May 18

• Very low pacemaker rate following transfemoral implantation of a self-expanding valve: Acurate neo/TF Low PPM

• Thirty-day outcomes in patients treated with a repositionable and fully retrievable aortic valve designed to reduce the incidence of conduction disturbances: RESPOND Extension study

• (LBCT) Real world net benefit of LAA closure at one year: safety and efficacy results in the EWOLUTION all-comers study

Multiple significant BSX data releases during EuroPCR 2017,

including four late breaking clinical trials (LBCT)

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Questions?

13 *CE Marked. Not available for use or sale in the U.S.

**Not available for use or sale.

IC Category Leadership – Breadth of Portfolio

*

**

TRANSFEMORAL TAVI SYSTEM