Professional Documents
Culture Documents
August 8, 2012
Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb is not approved or available for sale in Mexico. Rev. A
Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb is not approved or available for sale in Mexico. Rev. A
n 50 45 63 20 117 46 30 26
Outcome 18% restenosis @ 12-months 50% restenosis @ 6-months 48% restenosis @ 12-months 90% clinical patency @ 3-months 68% restenosis @ 6-months 4.7% TLR @ 12-months 67% TLR @ 6-months Follow-up ongoing
Igaki-Tamai
REVA
ABSORB Cohort B*
Absorb
coronary
101
Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb is not approved or available for sale in Mexico. Rev. A
2012
2013
2014
2015
2016
ABSORB Cohort B
APPROVAL
N = 101; FIM
ABSORB III
N = ~2,200
ABSORB Japan
N = 500
Enrollment & Follow-Up 1Y Enrollment & Follow-Up 1Y Enrollment & Follow-Up Enrollment & Follow-Up
2Y 2Y
ABSORB China
N = ~400
THERAPY ADVANCEMENT
ABSORB Extend
N = ~1,000
2Y 2Y
3Y 3Y
ABSORB II
N = ~500
ABSORB IV
N = ~3000
ABSORB Diabetics
Multi Country Trial Regional & National Therapy Demonstration Projects UK, Sweden, and France
Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb is not approved or available for sale in Mexico. Rev. A
Bioresorbable Coating
Everolimus
All illustrations are artists renditions Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb is not approved or available for sale in Mexico. Rev. A 5
Absorb
1 month 6 months 1 year 2 years 3 years 4 years
CYPHER
1 month 6 months 1 year 2 years 3 years 4 years
Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb is not approved or available for sale in Mexico. Rev. A
Onuma Y, Serruys PW, Perkins LEL, Okamura T, Gonzalo N, Garcia-Garcia HM, et al. Intracoronary optical coherence tomography and histology at 1 month and 2, 3, and 4 years after implantation of everolimus-eluting bioresorbable vascular scaffolds in a porcine coronary artery model. An attempt to decipher the human optical coherence tomography images in the ABSORB trial. Circ 2010;122:1912-1924.
Lower MCUSA (maximum unsupported scaffold area) More even support of arterial wall More uniform strut distribution Lower late stent area loss Improved stent retention Unchanged material and strut thickness
Onuma Y, Piazza N, Ormison JA, Serruys PW. Everolimus-eluting bioarbsorbable stent - Abbott Vascular programme. Euroint 2009;5(suppl F):F98F102. 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 the performance of the first and second generation of the everolimus-eluting bioresorbable vascular scaffolds. Eur Heart J 2010.
Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb is not approved or available for sale in Mexico. Rev. A 8
Postprocedure
6-months
Postprocedure
6-months
Gomez-Lara J, Brugaletta S, Diletti R, Garg S, Onuma Y, Gogas BD, et al. A comparative assessment by optical coherence tomography of the performance of the first and second generation of the everolimus-eluting bioresorbable vascular scaffolds. Eur Heart J 2010.
Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb is not approved or available for sale in Mexico. Rev. A
Post-procedure
D Pre-procedure B A C
Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb is not approved or available for sale in Mexico. Rev. A
10
D C B A
Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb is not approved or available for sale in Mexico. Rev. A
11
EES: 0.10 0.23 mm (N = 22, SPIRIT First) BVS Cohort B: 0.19 0.18 mm (N = 42, ITT) BVS Cohort A: 0.44 0.35 mm (N = 26) BMS: 0.85 0.36 mm (N = 27, SPIRIT First)
-0.5
Serruys, PW. AHA 2010
0.5
1.5
Serruys, PW. ACC 2011
Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb is not approved or available for sale in Mexico. Rev. A
12
0 Absorb BVS(B1+B2) At Risk XV(3.0 x 18 mm subgroup, SPI+SPII+SPIII RCT) At Risk ABSORB EXTEND April 2012 101 227
194 96 219
393 94 204
758 91 191
Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb is not approved or available for sale in Mexico. Rev. A
13
1mo
6mo
12mo
2yr
3yr
First-in-Man Study, safety and performance of the Absorb BVS in subjects with CLI from occlusive vascular disease of the tibial arteries Freedom from major adverse limb events (major amputation or major reinterventions) occurring within one year or peri-procedural (30-day) death (MALE+POD) Procedural, clinical, hemodynamic, angiographic and functional endpoints in hospital & at each FU visit
14
Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb is not approved or available for sale in Mexico. Rev. A
First Case of Drug-Eluting Resorbable Scaffold Implantation in the Peripheral Vasculature: ABSORB BTK
Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb is not approved or available for sale in Mexico. Rev. A
15
Absorb, ESPRIT, XIENCE PRIME and XIENCE V are trademarks of the Abbott Group of Companies. Cypher is a trademark of Johnson & Johnson, Inc
Information contained herein for presentation outside the US and outside Japan ONLY. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb is not approved or available for sale in Mexico. Rev. A 16