html5-img
1 / 38

Keith Dawkins MD FRCP FACC FSCAI Chief Medical Officer Senior Vice President Boston Scientific Corporation

Boston Scientific Programme Update. Keith Dawkins MD FRCP FACC FSCAI Chief Medical Officer Senior Vice President Boston Scientific Corporation. London – January 26, 2011. Conflicts of Interest. Employee Boston Scientific Corporation Stockholder Boston Scientific Corporation.

natalya
Download Presentation

Keith Dawkins MD FRCP FACC FSCAI Chief Medical Officer Senior Vice President Boston Scientific Corporation

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Boston Scientific Programme Update Keith Dawkins MD FRCP FACC FSCAI Chief Medical Officer Senior Vice President Boston Scientific Corporation London – January 26, 2011

  2. Conflicts of Interest • Employee • Boston Scientific Corporation • Stockholder • Boston Scientific Corporation

  3. Element Stent Platform • Next Generation DES • BSC Structural Heart Programme • Sadra Lotus™ Valve • Atritech Watchman Device

  4. Element Stent Platform Geometry designed for drug delivery Four stent models Consistent surface-to-artery ratios Apex™ balloon Bi-component balloon Multilayer Platinum Chromium Alloy Thin struts Radio-opaque Low recoil High radial strength

  5. Platinum Chromium (Element Stent) Chromium 18% Nickel 9% Platinum* 33% Molybdenum 2.6% Iron 37% *Platinum fully incorporated in the alloy (not coating) Manganese 0.05%

  6. Comparative Radial Strength Radial Fore (Newtons/mm) Xience V Endeavor Cypher Taxus Liberté Taxus Element Xience Prime Platinum Chrome Stainless Steel Cobalt Chrome Platinum Chrome has 36% less Recoil than Cobalt Chrome

  7. Comparative Stent Recoil Percent (%) Recoil Xience V Endeavor Xience Prime Cypher Taxus Liberté Taxus Element Platinum Chrome Stainless Steel Cobalt Chrome Platinum Chrome has 70% more Radial Strength than Cobalt Chrome

  8. Fracture Resistance (Bend Fatigue) 306x Average Bend Cycles before Fracture (million) Stent Strut Thickness (µm) Taxus Express Taxus Liberté Taxus Element Taxus Element has Thinner Struts and Higher Fracture Resistance

  9. Comparative Drug Load Drug Weight (μg)* Promus Element Cypher Endeavor Resolute BioMatrix BioFreedom *Drug Load 3.0 x 18mm stent

  10. PLATINUM QCA Trial in Perspective Promus Element Stent Promus/Xience Stent Late Loss (mm) N=23 N=237 N=301 N=20 N=73 SPIRIT First SPIRIT II SPIRIT III PLATINUM QCA SPIRIT First 6mths 6mths 8mths 9mths 12mths Increasing Time to Follow-up EuroInterv 2010 (in press)

  11. PLATINUM QCA Trial (IVUS)Incomplete Stent Apposition (ISA) Promus Element Stent Promus/Xience Stent Performance Goal (SPIRIT III: Promus/Xience) p<0.001 Incomplete Stent Apposition (ISA) (%) Post-Procedure ISA Late-Acquired ISA Late ISA EuroInterv 2010 (in press)

  12. PLATINUM QCA TrialClinical Results (N=100) 30 Days 12 Mths *Ischemia-driven TLR, or MI/cardiac death related to the target vessel (All events occurred in the same patient) EuroInterv 2010 (in press)

  13. PLATINUM Clinical Program PROMUS® ELEMENT™Stent in de novo lesions PLATINUM WH, SV, LL PLATINUM QCA Trial/Subtrial Workhorse Small Vessel Long Lesion # of Patients 1,532 94 102 100 # of Sites 160 (Worldwide) 20 (US & Japan) 20 (US & Japan) 10 (IC) Trial Design 1:1 Randomized, Single Blind Single Arm Single Arm Single Arm Success Criteria Non-inferiority Non-inferiority Non-inferiority N/A Test Stent PROMUS Element Stent PROMUS Element Stent Control Stent PROMUS Stent Historical PROMUS Stent Data from SPIRIT Trials N/A Primary Endpoint 12M TLF 12M TLF 12M TLF 30 day cardiac events

  14. Next Generation DES

  15. Next Generation DES Attributes Deliverable, Visible, Trackable Conformable • Reduced Polymer Load • Ablumenal Polymer • Bioerodable Polymer • No Polymer • Reduced Drug Load • Stent Delivery System • Stent Material • Thinner Struts • Modified Stent Geometry • Surface Coating • No Stent • Thrombosis • (‘BMS’ like) • Shortened DAPT Requirement • Low TLR, Low Clinical Symptom Recurrence

  16. The Burden of Stent Thrombosis... Thrombus Cost DAPT Hemorrhage

  17. BSC Next Generation DES • Bioerodable PLGA polymer is only applied to the abluminal surface of the stent • Maximum coating thickness 3μm (1/2 dose) and 4μm (standard dose)

  18. SYNERGY Stent SYNERGY DES Abluminal Bioerodable Polymer Current DES Conformable Durable Polymer +6 months Arterial Wall Everolimus + Ultra-thin Bioerodable PLGA Polymer applied to abluminal aspect of a 0.0028” stent strut

  19. SYNERGY Relative Polymer Thickness Micron (µ) μ SYNERGY Polymer (Thickness) E. Coli (Length) Red Cell (Diameter) T. Liberté Polymer (Thickness) Neutrophil (Diameter) SYNERGY = Minimal Drug + Ultrathin Bioerodable Abluminal Polymer

  20. Relative Drug Coating Weights Bare Metal Nevo T. Liberté BioMatrix Promus SYNERGY ½D SD // // // l l l l l l l l l l l 0 50 100 150 200 250 300 350 500 685 1267 Coating Weight (Drug + Polymer) (µg/16mm Stent)

  21. Stent Strut Thickness Strut Thickness (inches) EVOLVE Synergy stent strut thickness = 0.0032” Synergy* 0.0029” Cypher 0.0055” Express 0.0052” Element 0.0032” Liberté 0.0038” Vision 0.0032” Driver 0.0036”

  22. EVOLVE Trial - Study Flow

  23. EVOLVE Trial - Recruitment Patients (N) 2010 2011

  24. Future Growth in Interventional Cardiology is Driven by Segments that are Small Today $16.3B +8.6% $10.5B Worldwide IC Market ($B) $8.3B +4.8% * *Core = DES, BMS, DEB, Atherectomy, Balloons, Wires, Access, Imaging, & EPI BSC Internal data

  25. Aortic Stenosis: The Facts… • Untreated Aortic Stenosis has a poor natural history • Many patients are not referred for investigation or treatment • Excellent results for surgical AVR • Superior TAVI results vs. OMT for inoperable patients • Long-term TAVI leaflet durability unknown • Role of TAVI for surgically suitable patients uncertain Pk Grad = 118.1 mmHg Vmax = 5.43 m/sec

  26. Population Projections Office for National Statistics (2008) 699,000 (0.8%) Population ≥100 years of Age (%) http://www.statistics.gov.uk/downloads/theme_population/NPP2008/NatPopProj2008.pdf

  27. At Least 30% of Patients with Severe Symptomatic Aortic Stenosis are Untreated… Bouma 1999 lung 2003 Pellikka 2005 Charlson 2006 Bach 2009 Spokane (Prelim) Vannan (In press) Under treatment is especially prevalent among patients managed by Primary Care Physicians Modified from Kodali, TCT 2010

  28. Euro Heart SurveyFactors Associated with the Absence of Aortic Valve Intervention Modified from Kodali, TCT 2010 Eur Heart J 2003;24:1231-1243

  29. TAVI: Procedure Success Percent (%) PARTNER B N=62 N= 179 N=108 N= 66 N=119 N=588 N= 460 N= 772 Meredith, TCT 2009; Avanzas Rev EspCardiol 2010;63:141-148 Eltchaninoff, EuroPCR 2010; Bosmans, EuroPCR 2010 Zahn, EuroPCR 2010; Ludman, EuroPCR 2010; Petronio, EuroPCR 2010 Leon, N Engl J Med 2010;363:1597-1607

  30. TAVI: 30-Day All-Cause Mortality Percent (%) PARTNER B N=62 N= 179 N=108 N= 66 N=119 N=588 N= 460 N= 772 Meredith, TCT 2009; Avanzas Rev EspCardiol 2010;63:141-148 Eltchaninoff, EuroPCR 2010; Bosmans, EuroPCR 2010 Zahn, EuroPCR 2010; Ludman, EuroPCR 2010; Petronio, EuroPCR 2010 Leon, N Engl J Med 2010;363:1597-1607

  31. TAVI: 30-Day Stroke Rate Percent (%) PARTNER B N= 179 N= 66 N=119 N=588 N= 460 N= 772 Eltchaninoff, EuroPCR 2010; Bosmans, EuroPCR 2010 Zahn, EuroPCR 2010; Ludman, EuroPCR 2010; Petronio, EuroPCR 2010 Leon, N Engl J Med 2010;363:1597-1607

  32. TAVI: Pooled Monitored StudiesChanges in AR Grade with Time Patients (%) 25% of TAVI Recipients have ≥2+ AR at 24 months Modified from Kodali, TCT 2010

  33. TAVI Displacement (Dislocation) p=0.024 30-Day Mortality (%) 21/212 191/212 Displacement No Displacement In an experienced centre, CoreValve dislocation during TAVI occurred in10% of cases and significantly increased peri-procedural risk for severe complications and death Circ Cardiovasc Interv 2010;3:531-536

  34. Sadra Medical Inc • Founded 2004. Start-up company • Headquarters: Los Gatos CA • Acquired by Boston Scientific (November 19, 2010) • FHU Feasibility Trial (EU) Completed 2010 • First Lotus™ Valve: >3 year follow-up • CE-Mark Trial to commence 2011 (Australia, Germany, UK) http://www.sadramedical.com

  35. The Lotus™ Valve • Pre-loaded Valve • 18F Delivery System • 23mm & 27mm Diameter • Accurate Placement & Repositionable • True Retrievability • Negligible Aortic Regurgitation Deploy Retrieve Release

  36. Atritech • Founded in 2000. Early commercial company • Headquarters Minneapolis MN • Acquired by BSC ( January 19, 2011) • Watchman LAA Closure Device (CE-Mark 2005) http://www.atritech.net

  37. LAA occlusion for patients intolerant or unsuitable for warfarin or newer anticoagulants (bleeding risk, poor control) • Watchman implant undertaken by electrophysiologists or interventional cardiologists • Implant as a stand-alone procedure or at the time of AF ablation NEJM 2009;360:2601-2602

  38. Conclusions • BSC has a robust product pipeline and is midway through a period of transformation (restructuring, acquisitions and divestitures) • The SYNERGY stent will build on the ELEMENT stent platform, delivering abluminal everolimus via a bioerodable polymer • The Lotus™ valve and the Watchman device offer significant diversification and growth opportunities within the BSC core cardiology portfolio

More Related