BVS for BTK

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Disclosures: Full time employee of Abbott Vascular. Dra. Moreira Rebeca.SOLACI México Congress 2012. Find more presentations on the web site: www.solaci.org/

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BVS for BTK

  1. 1. Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorizedfor sale in CE Mark countries. Please check the regulatory status of the device before distribution in areaswhere CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb isnot approved or available for sale in Mexico.©2012 Abbott. All rights reserved. AP2937175-OUS Rev. A1BVS for BTKRebecca MoreiraDirector, R&DAbbot VascularSanta Clara, CAAugust 8, 2012
  2. 2. Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorizedfor sale in CE Mark countries. Please check the regulatory status of the device before distribution in areaswhere CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb isnot approved or available for sale in Mexico.©2012 Abbott. All rights reserved. AP2937175-OUS Rev. A2DISCLOSURES:Full-time Employeeof Abbott Vascular
  3. 3. Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorizedfor sale in CE Mark countries. Please check the regulatory status of the device before distribution in areaswhere CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb isnot approved or available for sale in Mexico.©2012 Abbott. All rights reserved. AP2937175-OUS Rev. A3Device Study Lesions n OutcomeIgaki-TamaiIgaki-Tamai FIM coronary 50 18% restenosis @ 12-monthsPERSEUS SFA 45 50% restenosis @ 6-monthsAMSPROGRESS AMS coronary 63 48% restenosis @ 12-monthsBEST BTK infrapopliteal 20 90% “clinical patency” @ 3-monthsAMS INSIGHT infrapopliteal 117 68% restenosis @ 6-monthsBIOSOLVE-I coronary 46 4.7% TLR @ 12-monthsREVARESORB coronary 30 67% TLR @ 6-monthsRESTORE coronary 26 Follow-up ongoingAbsorbABSORBCohort B*coronary 1012.0% TLR @ 6-months4.0% TLR @ 12-monthsBioresorable Scaffolds - Clinical Studies*Other ABSORB studies discussed in following slide
  4. 4. Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorizedfor sale in CE Mark countries. Please check the regulatory status of the device before distribution in areaswhere CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb isnot approved or available for sale in Mexico.©2012 Abbott. All rights reserved. AP2937175-OUS Rev. A42011 2012 2013 2014 2015 2016ABSORBPHYSIOLOGY N = ~35ABSORB IVN = ~3000ABSORB JapanN = 500ABSORB Cohort AN = 30; FIMABSORB Cohort BN = 101; FIMABSORB IIIN = ~2,200ABSORB ChinaN = ~400ABSORB ExtendN = ~1,000ABSORB IIN = ~5005Y1Y 2Y 3Y 4Y 5Y2Y2Y2Y 3Y2Y 3Y1Y1Y1Y1YEnrollment & Follow-UpEnrollment & Follow-UpEnrollment & Follow-UpEnrollment & Follow-UpEnrollment & Follow-UpEnrollment/Study CloseEnrollment & Follow-UpABSORB FirstMulti Country TrialIn PlanningIn PlanningPost approvalregistries focusedFirst Time, Youngand DiabeticsAPPROVALTHERAPYADVANCEMENTABSORB DiabeticsMulti Country TrialRegional & National TherapyDemonstration ProjectsUK, Sweden, and FranceIn PlanningData on file at Abbott VascularABSORB Clinical Trial Program
  5. 5. Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorizedfor sale in CE Mark countries. Please check the regulatory status of the device before distribution in areaswhere CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb isnot approved or available for sale in Mexico.©2012 Abbott. All rights reserved. AP2937175-OUS Rev. A5Absorb Bioresorbable Vascular Scaffold SystemComponentsBioresorbableCoating• Poly (D,L-lactide)(PDLLA)• Naturallyabsorbed, fullymetabolized• Similar dosedensity andrelease rate toXIENCE VEverolimus• Poly (L-lactide)(PLLA)• Naturallyabsorbed, fullymetabolizedBioresorbableScaffoldXIENCE V DeliverySystem• World-classdeliverabilityAll illustrations are artists’ renditions
  6. 6. Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorizedfor sale in CE Mark countries. Please check the regulatory status of the device before distribution in areaswhere CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb isnot approved or available for sale in Mexico.©2012 Abbott. All rights reserved. AP2937175-OUS Rev. A6Porcine Coronary Study:Representative Photomicrographs (2x)AbsorbCYPHERPhotos taken by and on file at Abbott Vascular.2 years1 month 6 months 1 year 3 years1 month 6 months 1 year 2 years 3 years4 years4 yearsTests performed by and data on file at Abbott Vascular.Absorb vs. CYPHER
  7. 7. Porcine Coronary Study: Representative PhotomicrographsOnuma Y, Serruys PW, Perkins LEL, Okamura T, Gonzalo N, Garcia-Garcia HM, et al. Intracoronary optical coherence tomography and histology at 1 monthand 2, 3, and 4 years after implantation of everolimus-eluting bioresorbable vascular scaffolds in a porcine coronary artery model. An attempt to decipher thehuman optical coherence tomography images in the ABSORB trial. Circ 2010;122:1912-1924.Abbott Vascular Everolimus-ElutingBioresorbable Vascular Scaffold
  8. 8. Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorizedfor sale in CE Mark countries. Please check the regulatory status of the device before distribution in areaswhere CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb isnot approved or available for sale in Mexico.©2012 Abbott. All rights reserved. AP2937175-OUS Rev. A8• Lower MCUSA (maximumunsupported scaffold area)• More even support of arterialwall• More uniform strut distribution• Lower late stent area loss• Improved stent retention• Unchanged material and strutthicknessOnuma Y, Piazza N, Ormison JA, Serruys PW. Everolimus-eluting bioarbsorbable stent - Abbott Vascular programme. Euroint 2009;5(suppl F):F98-F102. 009;373:897-910.Gomez-Lara J, Brugaletta S, Diletti R, Garg S, Onuma Y, Gogas BD, et al. A comparative assessment by optical coherence tomography of theperformance of the first and second generation of the everolimus-eluting bioresorbable vascular scaffolds. Eur Heart J 2010.ABSORB Cohorts A & B
  9. 9. Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorizedfor sale in CE Mark countries. Please check the regulatory status of the device before distribution in areaswhere CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb isnot approved or available for sale in Mexico.©2012 Abbott. All rights reserved. AP2937175-OUS Rev. A9Gomez-Lara J, Brugaletta S, Diletti R, Garg S, Onuma Y, Gogas BD, et al. A comparative assessment by optical coherence tomography of theperformance of the first and second generation of the everolimus-eluting bioresorbable vascular scaffolds. Eur Heart J 2010.COHORT A COHORT BABSORB Cohorts A & BPost-procedure6-months Post-procedure6-months
  10. 10. Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorizedfor sale in CE Mark countries. Please check the regulatory status of the device before distribution in areaswhere CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb isnot approved or available for sale in Mexico.©2012 Abbott. All rights reserved. AP2937175-OUS Rev. A10ABCDEA B C D EPost-procedurePre-procedure
  11. 11. Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorizedfor sale in CE Mark countries. Please check the regulatory status of the device before distribution in areaswhere CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb isnot approved or available for sale in Mexico.©2012 Abbott. All rights reserved. AP2937175-OUS Rev. A11A’B’C’D’ E’A’ B’ C’ D’ E’
  12. 12. Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorizedfor sale in CE Mark countries. Please check the regulatory status of the device before distribution in areaswhere CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb isnot approved or available for sale in Mexico.©2012 Abbott. All rights reserved. AP2937175-OUS Rev. A12QCA Results at 6 and 12 MonthsSerruys, PW. ACC 2011Serruys, PW. AHA 2010Late Loss at 6 Months (Group 1, N = 45) 12 Months (Group 2, N = 56)-0.5 0.5 1.5BMS: 0.85 ± 0.36 mm (N = 27, SPIRIT First)BVS Cohort A: 0.44 ± 0.35 mm (N = 26)BVS Cohort B: 0.19 ± 0.18 mm (N = 42, ITT)EES: 0.10 ± 0.23 mm (N = 22, SPIRIT First)
  13. 13. Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorizedfor sale in CE Mark countries. Please check the regulatory status of the device before distribution in areaswhere CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb isnot approved or available for sale in Mexico.©2012 Abbott. All rights reserved. AP2937175-OUS Rev. A13ABSORB Cohort B to 2 Years:Comparable Rates with XIENCE0 194 393 758Absorb BVS(B1+B2) At Risk 101 96 94 91XV(3.0 x 18 mm subgroup, SPI+SPII+SPIII RCT) AtRisk227 219 204 191ABSORB EXTENDApril 2012KM estimate of MACE rate in patients treated with Absorb BVS (ABSORB Cohort B, n=101)vs. patients treated with a single 3x 18 mm metallic XIENCE V (SPIRIT First+II+III, n=227)Absorb BVS(B1+B2)XIENCE V (3.0 x 18mm subgroup,SPI+SPII+SPIII RCT)
  14. 14. Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorizedfor sale in CE Mark countries. Please check the regulatory status of the device before distribution in areaswhere CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb isnot approved or available for sale in Mexico.©2012 Abbott. All rights reserved. AP2937175-OUS Rev. A14ABSORB BTK TrialTreatment of single de novo lesion in BTK vessel, length < 48 mm, in 90patients with critical limb ischemia (CLI)• Prospective, Single Arm, Multi-Center Trial in Europe and Asia-Pacific• Absorb BVS sizes: 3.0 x 18 mm, 3.0 x 28 mm• Single target lesion treated with Absorb BVS or planned overlap of two Absorb BVS• Treatment of one or more non-target lesion(s) in separate vessel(s) allowed withcommercial device(s)Study Objective:Primary Endpoint:First-in-Man Study, safety and performance of the Absorb BVS in subjects with CLIfrom occlusive vascular disease of the tibial arteriesFreedom from major adverse limb events (major amputation or major reinterventions)occurring within one year or peri-procedural (30-day) death (MALE+POD)Secondary Endpoints: Procedural, clinical, hemodynamic, angiographic and functional endpoints inhospital & at each FU visitBaseline 1mo 6mo 12mo 2yr 3yrMSCT/ MR Substudies (N ~ 5 each)OCT Substudy (N ~ 10)Angiography (all subjects)Clinical, Duplex (all subjects)
  15. 15. Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorizedfor sale in CE Mark countries. Please check the regulatory status of the device before distribution in areaswhere CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb isnot approved or available for sale in Mexico.©2012 Abbott. All rights reserved. AP2937175-OUS Rev. A15First Case of Drug-Eluting Resorbable Scaffold Implantationin the Peripheral Vasculature: ABSORB BTKPeronealArteryStenosisABSORBEverolimus-elutingResorbable Scaffold
  16. 16. Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorizedfor sale in CE Mark countries. Please check the regulatory status of the device before distribution in areaswhere CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb isnot approved or available for sale in Mexico.©2012 Abbott. All rights reserved. AP2937175-OUS Rev. A16Absorb, ESPRIT, XIENCE PRIME and XIENCE V are trademarks of the Abbott Group of Companies.Cypher is a trademark of Johnson & Johnson, Inc

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