IN-SERVICE PRESENTATION - rotablation-wroclaw.pl

1 IN-SERVICE PRESENTATION IC-215308-AG OCT2015 1 of 84 This material is not for use in the , France or Japan. What have we achieved together? E v o l u t i o n o f S t e n t D e s i g n A D VA N C I N G C A R D I O L O G Y T O G E T H E R SYNERGY Stent System Promus PREMIER Stent System TAXUS Element and PROMUS Element Stent Systems TAXUS Libert Stent System TAXUS Express2 Stent System PROMUS Stent System 2003 2005 2006 2009-2010 2013 2013 IC-215308-AG OCT2015 2 of 84 This material is not for use in the , France or Japan. Because you never know when life will become complex.

2 The SYNERGY Stent System is uniquely suited for challenging cases. DESIGNED TO HEAL UNMATCHED ACUTE PERFORMANCE This material is not for use in the , France or Japan. IC-215308-AG OCT2015 3 of 84 Vascular Response to Current Permanent Polymers The case for bioabsorbable polymer coatings CoCr EES EES implanted within PES (6 months antemortem) CoCr EES Foamy macrophage accumulation (neoatherosclerosis) CoNi ZES Chronic inflammation with giant cells secondary to polymer delamination (3 months) CoCr EES Focal inflammation with eosinophils (4 months) Focal Inflammation Chronic Inflammation Neo- Atherosclerosis Late Stent Thrombosis Images Courtesy of Renu Virmani, MD.

3 This material is not for use in the , France or Japan. IC-215308-AG OCT2015 4 of 84 No. at risk Resolute Stent 1140 1110 1035 992 960 920 Xience V Stent 1152 1122 1031 995 959 926 2nd Generation DES Continuous accrual of Events 40 Years 0 1 3 2 TLF Rate (%) 0 10 30 Log rank P = Resolute ZES (N = 1140) Xience V EES (N = 1152) Primary endpoint Pnon-inferiority < 20 5 4 ~2% Event Rate/Year after Year 1 RESOLUTE All Comers TLF = cardiac death, target vessel MI or clinical driven TLR Adapted from a PRESENTATION by Stephan Windecker, MD at PCR 2014.

4 This material is not for use in the , France or Japan. IC-215308-AG OCT2015 5 of 84 DES Polymer Considerations Provide a mechanically stable matrix for the drug Modulate drug release into the vessel wall Polymer remaining after drug release has no function All polymer coatings have the potential to be damaged Permanent polymers are permanent What is the purpose of a DES polymer? What happens after drug release? Clinical Implications Late / very late events Chronic inflammation with neoathersclerosis Constant irritant may lead to late restenosis Boston Scientific data on file.

5 This material is not for use in the , France or Japan. IC-215308-AG OCT2015 6 of 84 SYNERGY Stent System HEAL with Confidence Designed to Heal Early Healing Freedom from Long-term Polymer Exposure This material is not for use in the , France or Japan. IC-215308-AG OCT2015 7 of 84 SYNERGY Stent System HEAL with Confidence Designed to Heal Early Healing Freedom from Long-term Polymer Exposure This material is not for use in the , France or Japan. IC-215308-AG OCT2015 8 of 84 Impact of Stent Design on Healing Strut thickness Polymer Location Polymer Load and Duration Design Factors Impacting Healing Optimal Healing Increased Endothelial Coverage Reduced Inflammation Reduced Likelihood of Stent Thrombosis This material is not for use in the , France or Japan.

6 IC-215308-AG OCT2015 9 of 84 Arterial Wall PROMUS Element Stent Conformal Permanent Polymer SYNERGY Stent Abluminal PLGA Bioabsorbable Polymer 20% Thinner Struts 78 m* Strut + Polymer 97 m Strut + Polymer SYNERGY Everolimus-Eluting Stent Product Summary Polymer is gone when no longer needed, shortly after completion of drug elution at 3 months Applied to the abluminal side of the stent, designed for optimal healing Providing Suppression of neointimal growth at the arterial wall & Promotion of healing inside the lumen *Strut thickness for small vessel model is 74 m, Workhorse model is 79 m and large vessel is 81 m.

7 Boston Scientific data on file. Synchrony Bioabsorbable Coating Thin Abluminal Coating This material is not for use in the , France or Japan. IC-215308-AG OCT2015 10 of 84 SYNERGY Stent Synchrony Bioabsorbable Coating Wilson, , et al. Catheter Cardiovasc Interv. 2015. PLGA Mass Remaining Everolimus Mass Remaining 100 80 60 40 20 0 0 3 6 9 12 Time (months) Mass Remaining (%) Freedom from long-term polymer exposure Polymer is completely absorbed when it is no longer needed This material is not for use in the , France or Japan.

8 IC-215308-AG OCT2015 11 of 84 Synchrony Bioabsorbable Coating Drug Arterial Concentration and Release Kinetics 03690306090120 Everolimus Tissue Concentration (ng/mg) Time (days) SYNERGYPROMUS Element02550751000306090% Everolimus Release Time (days) SYNERGYPROMUS Element Arterial Everolimus Concentration* Drug Release Profiles* The SYNERGY Stent has similar release kinetics and arterial drug concentrations as Promus PREMIER Stent Everolimus is still present in the tissue out to 120 days while polymer completes absorption SYNERGY Stent Promus PREMIER Stent SYNERGY Stent Promus PREMIER Stent Wilson, , et al.

9 Cathet. Cardiovasc. Intervent. *Data points determined from an in vivo non-injured swine model. This material is not for use in the , France or Japan. IC-215308-AG OCT2015 12 of 84 Bioabsorbable Scaffold Bioabsorbable Polymer in Perspective Relative Polymer and Drug Absorption Profiles 1 Boston Scientific data on file. 2 World J Cardiol 2011 March 26; 3(3): 84-92. 3 Garg, S, J Am Coll Cardiol. 2010;56 (10s1):S43-S78. 4 Presented by Stephan Windecker, MD, TCT2012. Absorb BVS3 Polymer Scaffold: PLLA Polymer Coating: PDLLA Absorption Time: >2 yrs Bioabsorbable Polymer-Coated Stents SYNERGY 1 Stent Polymer Coating: PLGA Absorption Time: 3-4 mo Polymer Coating: PLA Absorption Time: >9 mo Nobori 2 and BioMatrix Flex 3 Stents Orsiro 4 Stent Polymer Coating: PLLA Absorption Time.

10 >12 mo % Recovery Time (months) Everolimus PLGA % Recovery Time (months) BA9 PLA % Recovery Time (months) Sirolimus PLLA (molecular weight change) % Recovery Time (months) Everolimus PLLA This material is not for use in the , France or Japan. The SYNERGY Stent s polymer is absorbed shortly after drug elution ends at 3 months IC-215308-AG OCT2015 13 of 84 Metal Matters PtCr Alloy is the Foundation of Stent Performance Enhanced Visibility Exceptional Radial Strength & Conformability Minimized Recoil Key Advantages 37% 3% 9% 18% 33% Iron Molybdenum Nickel Chromium Platinum Trace Manganese Boston Scientific Corporation data on file.