The Importance of True Comparative Studies of Peripheral Vascular Disease

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1 The Importance of True Comparative Studies of Peripheral Vascular Disease Jeff Mirviss Senior Vice President and Global President Peripheral Interventions Division Boston Scientific Corporation Follow me on

2 Disclosures Employee and Stockholder of Boston Scientific Corp. This presentation includes products that have not been approved or cleared by the U.S. Food and Drug Administration and are not available for sale in the U.S.

3 Happy 40 th Birthday Angioplasty Picture from Angioplasty.org EuroPCR 2017

4 1980 Clinical Data by Andreas Greuntzig, MD Picture from Angioplasty.org

5 BSC Four Part Success Formula Meaningful Innovation Clinical Science HCP Education & Training Local Service & Support

6 CMS Review of the Level of Evidence in Peripheral Medicare Evidence Development & Coverage Advisory Committee Objective: Provide independent guidance and expert advice to CMS on specific clinical topics A review and evaluation of medical literature, technology assessment, public testimony and data examination Evaluation of the benefits, harms, and appropriateness of medical items and services MEDCAC judges the strength of available evidence and makes recommendations

7 2015 MEDCAC on Lower Extremity Peripheral Artery Disease (PAD) The MEDCAC voted on 6 questions concluding: Intermediate level of confidence in the evidence related to interventions for treating Intermittent Claudication and CLI patients As expected, the confidence was somewhat lower for asymptomatic PAD

8 2016 MEDCAC on Lower Extremity Chronic Venous Disease The MEDCAC voted on 4 questions concluding: Moderate level of confidence in interventions relating to varicose vein / chronic venous insufficiency The confidence was lower for chronic venous thrombosis and venous obstruction Greater confidence in the evidence supporting symptomatic patients vs. asymptomatic patients

9 Advancing Science for Life: Key Trials in Cardiovascular Disease MADIT-II SYNTAX PCI vs CABG for 3VD/LM Disease REPRISE III Lotus vs CoreValve in High and Extreme Risk Patients with AS HORIZONS AMI TAXUS vs BMS in STEMI PROTECT AF and PREVAIL Watchman vs Warfarin in Patients with AF PLATINUM Diversity PCI Outcomes in Understudied Patient Populations (Women and Minorities) EVOLVE FHU, II, China, Short DAPT Permanent-polymer EES vs BP-EES >50,000 Patients enrolled in BSC Interventional Cardiology/Structural Heart Trials 80%+ of U.S. patients who receive an ICD or CRT-D were first indicated for this lifesaving therapy by a BSC sponsored clinical trial.

10 Clinical Trial Hierarchy Is it safe? Does it work? How does it work in the real world? How does it compare to other devices? How does it work in patient populations? Preclinical + First Human Use Phase II Trial Pivotal trial All Comer Registries Head-to-Head Trials Meta Analysis

11 Clinical Trial Hierarchy Is it safe? Does it work? How does it work in the real world? How does it compare to other devices? How does it work in patient populations? PI Trials Have Focused Here Preclinical + First Human Use Phase II Trial Pivotal trial All Comer Registries Head-to-Head Trials Meta Analysis

12 Boston Scientific s DE Program: Putting the Evidence in Evidence-Based Medicine Eluvia tm Sustained Release Drug Eluting Stent: Majestic Trial 57 patients,14 sites Imperial Trial 465 patients, 75 sites, RCT head-to-head vs Zilver Ptx DES Eminent Trial 750 patients, 75 sites, RCT Eluvia vs BMS Regal Trial 500 patients, 30 sites, all comers registry SPORTS Trial 222 patients, 9 sites, RCT DES vs DCB vs BMS US Post Market Registry TBD More than 2,000 patients studied in over 200 global sites Includes BSC trials and Investigator Sponsored Research

13 Boston Scientific s DE Program: Putting the Evidence in Evidence-Based Medicine Ranger tm Drug Coated Balloon: Ranger Trial 105 patients, 10 sites, RCT Ranger DCB vs POBA Ranger II Trial 376 patients, 70 sites, RCT Ranger vs POBA Ranger SFA Registry 180 patients, 10 sites COMPARE Trial 414 patients, 15 sites, RCT Ranger DCB vs MDT InPact DCB US Post Market Registry TBD JET PCB Trial 250 patients, 25 sites, RCT Ranger + Jetstream Atherectomy vs Pre-Dil + Ranger DCB More than 1,500 patients studied in over 100 global sites

14 The Importance of True Comparative Studies Conclusion: The Peripheral field has been fairly characterized as having only intermediate level of evidence Patients are heterogeneous and one-device approach will likely not work in all patients, in all lesions, all the time We have confidence in our technologies and believe that more data will drive appropriate utilization, enable better patient outcomes and at lower cost The Peripheral field has evolved and physicians, payers and administrators expect data to understand how devices compare Boston Scientific is working on meaningful innovations along with contemporary data for you to deliver evidence-based medicine

15 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 forwardlooking 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.

16 The Importance of True Comparative Studies of Peripheral Vascular Disease Jeff Mirviss Senior Vice President and Global President Peripheral Interventions Division Boston Scientific Corporation Follow me on