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BVS for BTK

August 8, 2012

Rebecca Moreira Director, R&D Abbot Vascular Santa Clara, CA

2012 Abbott. All rights reserved. AP2937175-OUS

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

DISCLOSURES: Full-time Employee of Abbott Vascular

2012 Abbott. All rights reserved. AP2937175-OUS

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

Bioresorable Scaffolds - Clinical Studies


Device Study Igaki-Tamai FIM PERSEUS PROGRESS AMS BEST BTK AMS INSIGHT
AMS

Lesions coronary SFA coronary infrapopliteal infrapopliteal coronary coronary coronary

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

BIOSOLVE-I RESORB RESTORE

REVA

ABSORB Cohort B*
Absorb

coronary

101

2.0% TLR @ 6-months 4.0% TLR @ 12-months


*Other ABSORB studies discussed in following slide

2012 Abbott. All rights reserved. AP2937175-OUS

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

ABSORB Clinical Trial Program


2011 ABSORB Cohort A
N = 30; FIM 5Y 1Y 2Y 3Y 4Y 5Y

2012

2013

2014

2015

2016

ABSORB Cohort B

APPROVAL

N = 101; FIM

ABSORB III
N = ~2,200

Enrollment & Follow-Up

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

1Y 1Y Enrollment & Follow-Up

2Y 2Y

3Y 3Y

ABSORB II
N = ~500

ABSORB IV
N = ~3000

ABSORB PHYSIOLOGY N = ~35 ABSORB First


Multi Country Trial

Enrollment/Study Close In Planning In Planning In Planning

ABSORB Diabetics

Multi Country Trial Regional & National Therapy Demonstration Projects UK, Sweden, and France

Post approval registries focused First Time, Young and Diabetics


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Data on file at Abbott Vascular


2012 Abbott. All rights reserved. AP2937175-OUS

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

Absorb Bioresorbable Vascular Scaffold System Components

Bioresorbable Scaffold Poly (L-lactide) (PLLA) Naturally absorbed, fully metabolized

Bioresorbable Coating

Everolimus

XIENCE V Delivery System World-class deliverability

Poly (D,L-lactide) (PDLLA) Naturally absorbed, fully metabolized

Similar dose density and release rate to XIENCE V

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

2012 Abbott. All rights reserved. AP2937175-OUS

Absorb vs. CYPHER


Porcine Coronary Study: Representative Photomicrographs (2x)

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

Photos taken by and on file at Abbott Vascular.

Tests performed by and data on file at Abbott Vascular.


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2012 Abbott. All rights reserved. AP2937175-OUS

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

Abbott Vascular Everolimus-Eluting Bioresorbable Vascular Scaffold


Porcine Coronary Study: Representative Photomicrographs

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.

ABSORB Cohorts A & B

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

2012 Abbott. All rights reserved. AP2937175-OUS

ABSORB Cohorts A & B


COHORT A COHORT B

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

2012 Abbott. All rights reserved. AP2937175-OUS

Post-procedure

D Pre-procedure B A C

2012 Abbott. All rights reserved. AP2937175-OUS

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

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D C B A

2012 Abbott. All rights reserved. AP2937175-OUS

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

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QCA Results at 6 and 12 Months


Late Loss at 6 Months (Group 1, N = 45) 12 Months (Group 2, N = 56)

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

2012 Abbott. All rights reserved. AP2937175-OUS

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

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ABSORB Cohort B to 2 Years: Comparable Rates with XIENCE


KM 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)

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

2012 Abbott. All rights reserved. AP2937175-OUS

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

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ABSORB BTK Trial


Treatment of single de novo lesion in BTK vessel, length < 48 mm, in 90 patients 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 with commercial device(s) Baseline
Clinical, Duplex (all subjects) Angiography (all subjects) OCT Substudy (N ~ 10) MSCT/ MR Substudies (N ~ 5 each)

1mo

6mo

12mo

2yr

3yr

Study Objective: Primary Endpoint: Secondary Endpoints:

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
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2012 Abbott. All rights reserved. AP2937175-OUS

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

Peroneal Artery Stenosis

ABSORB Everolimus-eluting Resorbable Scaffold

2012 Abbott. All rights reserved. AP2937175-OUS

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

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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

2012 Abbott. All rights reserved. AP2937175-OUS