Structural Heart Investor Update

Transcription

1 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

2 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 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

3 IC Category Leadership Breadth of Portfolio * TRANSFEMORAL TAVI SYSTEM ** 3 *CE Marked. Not available for use or sale in the U.S. **Not available for use or sale.

4 Unique and Compelling TAVR Portfolio Offering Investing for leadership More Control for Each Patient 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 PVL = paravalvular leak; PPM = permanent pacemaker 4

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

6 % Percentage of Patients 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 < Primary Effectiveness Endpoint Components BSC (N = 607) MDT (N = 305) All Cause Mortality* Disabling Stroke* Moderate / > PVL* P = 0.51 P = 0.02 P < *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

7 LOTUS Valve: Significantly Lower Disabling Stroke at 1 Year Disabling Stroke % LOTUS Valve = 3.6% vs. CoreValve Platform = 7.3% P = 0.02 Disabling Stroke 1-Year CoreValve Lotus 7

8 % Patients LOTUS Valve: Significantly Lower PVL + Zero Valve-in-Valve and Zero Malpositioning % Patients % Patients Superior PVL Performance Significantly Lower Moderate PVL Rates Superior Procedural Outcomes Significantly Lower TAV in TAV and Valve Malpositioning 15 Moderate PVL Superiority P < Procedural Events % TAV in TAV 4 0% Valve Malpositioning CoreValve (N = 216) 2.0 LOTUS Valve (N = 216) TAV in TAV P < MDT 0 BSC 0.0 Valve Malpositioning P < * 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

9 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.

10 Watchman LAAC EWOLUTION All-Comers Study: Reduction in Ischemic Stroke and Major Bleeding 12% 10% 8% Expected, based on CHA2DS2-VASc* Observed in EWOLUTION 7.2% 12% 10% 8% Expected, based on HAS-BLED** Observed in EWOLUTION 6% 4% 2% 1.1% RR 84% 6% 4% 2% 5.0% 2.3% RR 54% 10 0% 0% Ischemic Stroke Major Bleeding Excl. Procedural *Effectiveness in stroke reduction vs. estimated in the absence of therapy for comparable CHA 2 DS 2 -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

11 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

12 12 Questions?

13 IC Category Leadership Breadth of Portfolio * TRANSFEMORAL TAVI SYSTEM ** 13 *CE Marked. Not available for use or sale in the U.S. **Not available for use or sale.