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
1
 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.

2
 IC Category Leadership Breadth of Portfolio

*
TRANSFEMORAL TAVI SYSTEM

**

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

3 **Not available for use or sale.
 Unique and Compelling TAVR Portfolio Offering
Investing for leadership

More Control for Each Patient

LOTUS ACURATE
Valve Platform Valve Platform

Complete Control Simplifying TAVI

Mechanically expanding platform designed for: Self expanding platform with:

Full repositioning and retrievability Intuitive implantation
Precise placement & freedom from PVL Precise placement & low PPM
Predictable results Flexible delivery system

PVL = paravalvular leak; PPM = permanent pacemaker

4
 REPRISE III Trial Design and Methods
First global head-to-head TAVR pivotal study

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

Heart Team assessment Case Review Committee confirmation

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

Neurologist examination

Lotus Valve (23, 25 & 27mm) CoreValve (26, 29 & 31mm)

Mechanically expanded Commercially available
Repositioning/retrieval in final position Self-expanding
Seal to minimise paravalvular leak CoreValve Classic / CoreValve Evolut R

Neurologist examination

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
Performed by a neurologist, neurology fellow, neurology physician assistant, or neurology nurse practitioner.
5 Feldman, EuroPCR 2017.
 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

MDT (N = 305)
15 Primary Effectiveness Endpoint Components
13.5 BSC (N = 607)
% Percentage of Patients

11.9
11.1

10
7.1

5 3.6
2.0

0
All Cause Mortality* Disabling Stroke* Moderate / > PVL*
P = 0.51 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.

6
LOTUS Valve:
Significantly Lower Disabling Stroke at 1 Year

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

P = 0.02

Disabling Stroke
1-Year CoreValve
Disabling Stroke %

Lotus

7
 LOTUS Valve: Significantly Lower PVL +
Zero Valve-in-Valve and Zero Malpositioning

Superior PVL Performance Superior Procedural Outcomes

Significantly Lower Significantly Lower TAV in TAV and
Moderate PVL Rates Valve Malpositioning

Moderate PVL Procedural Events

15 Superiority P < 0.001 5 5

0% Valve
0% TAV in TAV
11.1 4 4 Malpositioning

10 3.0

% Patients

% Patients
3 3
2.6
% Patients

2 2

5
1 1
2.0
0.0 0.0
0 0
TAV in TAV Valve Malpositioning
0 P < 0.001 P < 0.001
CoreValve LOTUS Valve
(N = 216) (N = 216) MDT BSC
* 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.

8
Acurate neo SAVI TF Registry:
Excellent outcomes, very low PPM rates

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

patients at 25 centers with the ACURATE neo Valve

Permanent pacemaker implanted 30 Day (N=994) 1 Year (N=983)

among all patients 8.2% 10.0%
9 Moellmann, EuroPCR 2017.
 Watchman LAAC EWOLUTION All-Comers Study:
Reduction in Ischemic Stroke and Major Bleeding

12% 12%
Expected, based on Expected, based on
CHA2DS2-VASc* HAS-BLED**
10% 10%
Observed in Observed in
EWOLUTION EWOLUTION
8% 8%
7.2%

6% 6%
RR 5.0%
4% 84% 4% RR
54%
2.3%
2% 2%
1.1%

0% 0%
Ischemic Stroke Major Bleeding Excl. Procedural
*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
10
 EuroPCR 2017 Key Data Releases

Multiple significant BSX data releases during EuroPCR 2017,

including four late breaking clinical trials (LBCT)

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

11
 Questions?

12
 IC Category Leadership Breadth of Portfolio

*
TRANSFEMORAL TAVI SYSTEM

**

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

13 **Not available for use or sale.