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©2014 Abbott. All rights reserved. AP2939615-OUS Rev. A 03/14 Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the regulation in force. For presentation only outside the United States. Miriam Bascones Ilundain

Presentacion cardio innova

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Page 1: Presentacion cardio innova

©2014 Abbott. All rights reserved.

AP2939615-OUS Rev. A 03/14

Absorb is authorized for sale in CE Mark and certain independently regulated

countries outside the United States. Please check the regulatory status of the

device before distribution in areas where CE Mark is not the regulation in force. For

presentation only outside the United States.

Miriam Bascones Ilundain

Page 2: Presentacion cardio innova

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United

States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the

regulation in force. For presentation only outside the United States. ©2014 Abbott. All rights reserved.

AP2939615-OUS Rev. A 03/14

Video Innovación.mp4

2

Page 4: Presentacion cardio innova

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United

States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the

regulation in force. For presentation only outside the United States. ©2014 Abbott. All rights reserved.

AP2939615-OUS Rev. A 03/14 4

¿QUÉ ES INNOVAR?

Page 5: Presentacion cardio innova

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United

States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the

regulation in force. For presentation only outside the United States. ©2014 Abbott. All rights reserved.

AP2939615-OUS Rev. A 03/14 5

BIOMIMÉTICA

Page 6: Presentacion cardio innova

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United

States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the

regulation in force. For presentation only outside the United States. ©2014 Abbott. All rights reserved.

AP2939615-OUS Rev. A 03/14

Page 7: Presentacion cardio innova

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United

States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the

regulation in force. For presentation only outside the United States. ©2014 Abbott. All rights reserved.

AP2939615-OUS Rev. A 03/14

Page 8: Presentacion cardio innova

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United

States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the

regulation in force. For presentation only outside the United States. ©2014 Abbott. All rights reserved.

AP2939615-OUS Rev. A 03/14

Page 9: Presentacion cardio innova

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United

States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the

regulation in force. For presentation only outside the United States. ©2014 Abbott. All rights reserved.

AP2939615-OUS Rev. A 03/14

Page 10: Presentacion cardio innova

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United

States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the

regulation in force. For presentation only outside the United States. ©2014 Abbott. All rights reserved.

AP2939615-OUS Rev. A 03/14 10

Atul Gawande

Page 11: Presentacion cardio innova

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United

States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the

regulation in force. For presentation only outside the United States. ©2014 Abbott. All rights reserved.

AP2939615-OUS Rev. A 03/14 11

Page 12: Presentacion cardio innova

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United

States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the

regulation in force. For presentation only outside the United States. ©2014 Abbott. All rights reserved.

AP2939615-OUS Rev. A 03/14 12

Page 13: Presentacion cardio innova

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United

States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the

regulation in force. For presentation only outside the United States. ©2014 Abbott. All rights reserved.

AP2939615-OUS Rev. A 03/14

Abbott VascularAbsorb

Abbott Vascular ha hecho inversiones importantes en tiempo, recursos y capital humano para liderar el campo de la tecnología bioreabsorbible y el campo de la cardiologíaintervencionista

R&D Commitment and Investment

$500 MILLION

260,000360approximately

more than

Absorb units built, tested, and validated

invested to research, develop, and commercialize Absorb

dedicated R&D and technical staff

Data on file at Abbott Vascular as of February 2014

13

Page 14: Presentacion cardio innova

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United

States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the

regulation in force. For presentation only outside the United States. ©2014 Abbott. All rights reserved.

AP2939615-OUS Rev. A 03/14

Abbott VascularAbsorb

Experiencia clínica y comercial global

Clinical / Special Access

Commercial

Leading global trials bytotal patient enrollment1

Available in over 60 countries worldwide since launch in 2012

Abbott-sponsored Absorb trials (10) = 9,709 patients Investigator-sponsored Absorb trials (14) = 12,894 patients Other bioresorbable platforms = 387 patients

1. Includes publically-disclosed in-progress and planned clinical trials for clinically active coronary bioresorbable platforms as of January 2014

Clinical trial patient data from TCT 2013 company presentations and Patel N, et al. Heart 2013:99 1236–1243. doi:10.1136/heartjnl-2012-303346

98.4%

1.6%

Absorb

Other

14

Page 15: Presentacion cardio innova

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United

States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the

regulation in force. For presentation only outside the United States. ©2014 Abbott. All rights reserved.

AP2939615-OUS Rev. A 03/14

Abbott VascularAbsorb

MULTI-LINK design

Everolimus and release profile

Benign resorption

Radiopaque markers

Minimal scaffold recoil

Radial strength

Room temperature storage and handling

Product shelf life

Atributos técnicos y prioridades del desarrollo

Current Generation Absorb Near-Term Investments

Expanded size matrix

Optimized scaffold delivery system for improved acute performance

Thinner scaffold struts and profile improvements for better deliverability

Enhanced expansion capabilities

Expanded size matrix

Next Generation Investments

15

Page 16: Presentacion cardio innova

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United

States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the

regulation in force. For presentation only outside the United States. ©2014 Abbott. All rights reserved.

AP2939615-OUS Rev. A 03/14

Abbott VascularPioneering the PCI Revolution with Absorb

Vessel SupportTime

Recoil

Radial Strength

Deliverability

Flexibility

Size Matrix

Radiopacity

Drug DeliveryProfile

ExpansionCapability

Strut Thickness

Consideraciones de próximas generaciones de dispositivos

bioreabsorbibles

To evaluate and balance various design characteristics and technical attributes

To create a polymer-based coronary bioresorbable vascular scaffold that offers DES-like performance and capabilities

16

Page 17: Presentacion cardio innova

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United

States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the

regulation in force. For presentation only outside the United States. ©2014 Abbott. All rights reserved.

AP2939615-OUS Rev. A 03/14

n=~599 n~965 n~5,709 n~7,609 n~8,709 n~9,709

2011 2012 2014 2014 2015 2016

ABSORB Japann = 400, Japan Pivotal RCT

Enrollment & Follow-Up 2 Y1 Y

ABSORB Chinan = 440, China Pivotal RCT

Enrollment & Follow-Up 2 Y1 Y

ABSORB IIn = ~501, International RCT

2 Y 3 Y1 YEnrollment & Follow-Up

ABSORB EXTENDn = 814, Registry

2 Y 3 Y1 YEnrollment & Follow-Up

ABSORB Cohort Bn = 101; FIM

1 Y 2 Y 3 Y 4 Y 5 Y

ABSORB Cohort An = 30; FIM

5 Y

ABSORB FIRSTn = ~2,000, International Registry

Enrollment & Follow-Up 1 Y

Each trial n reflects total patients. Data as of January 2014

*ABSORB IV trial is in the planning stage and subject to change

ABSORB IIIn = 2,235, US Pivotal RCT

Enrollment & Follow-Up 1 Y 2 Y

ABSORB IV*n = ~3,000, US RCT

UK Registryn = 1,000, UK Registry

Enrollment & Follow-Up 1 Y

Global Clinical and Commercial ExperienceComprehensive Abbott-Sponsored Clinical Program

Total Patients Studied

17

Page 18: Presentacion cardio innova

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United

States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the

regulation in force. For presentation only outside the United States. ©2014 Abbott. All rights reserved.

AP2939615-OUS Rev. A 03/14

Global Clinical and Commercial ExperienceInvestigator-Sponsored Studies (ISS)

18

Data on file at Abbott Vascular; data as of February 2014

*Enrollment has not started yet

Randomized Controlled Trials (2,764 Pts)

Study Title Country S-I Design

Enrolled /

Target

Patients

Primary Endpoint

Follow

Up

(Years)

AIDA Netherlands Dr. Henriques All-comers RCT vs. XIENCE 275 / 2,194 2-Year TVF 5

TROFI IINetherlands /

Spain / Switzerland

Dr. Serruys /

Dr. Sabaté /

Dr. Windecker

STEMI RCT vs. XIENCE 6 / 190 6-Month neo-intimal healing score 3

PROSPECT II

ABSORBNordics

Dr. Erlange /

Dr. Stone

RCT vs. OMT in unstable asymptomatic

patients0 / 300* 2-Year IVUS MLA 3

PROACTIVE Belgium Dr. Barbato RCT vs. XIENCE 1 / 20 Peri-procedure platelet reactivity 1

VANISH Netherlands Dr. Knaapen RCT vs. XIENCE 20 / 60 Evolution of myocardial blood flow over time 3

Registries (10,130 Pts)

BVS EXPAND Netherlands Dr. van Geuns All-comers Registry (excl. STEMI) 238 / 300 1-Year MACE 5

ASSURE Germany Dr. Mathey All-comers Registry 180 / 180 Safety and efficacy 3

ABSORB CTO Spain Dr. Serra Feasibility in CTO 20 / 20 Safety and performance 2

PABLOS Italy Dr. Colombo Feasibililty in Bifurcations 4 / 30 Device, procedural, main, and sidebranch success 2

IT-

DISSAPEARSItaly

Dr. Bedogni /

Dr. PetronioMVD and Long Lesion Registry 4 / 1,000 Safety and efficacy 5

GABI-R Germany/Austria Dr. Hamm All-comers Registry 66 / 5,000 Safety and efficacy 5

REPARA Spain/Portugal Dr. Hernandez All-comers Registry 1 / 1,500 1-Year MACE 1

POLAR ACS Poland Dr. Dudek ACS Registry 100 / 100Safety, clinical device, procedure success and in-

hospital MACE1

France

ABSORB France

Dr. Koning /

Dr. Le BretonFeasibility in de novo lesions 0 / 2,000* 1-Year MACE 1

Page 19: Presentacion cardio innova

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United

States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the

regulation in force. For presentation only outside the United States. ©2014 Abbott. All rights reserved.

AP2939615-OUS Rev. A 03/14

“En una ocasión salí de la ciudad y a la vuelta, en un punto

en el que la tierra se elevaba y veía el mar a la izquierda y

toda la carretera por delante, de pronto sentí que estaba en

el cielo. En realidad el lugar era exactamente el mismo que

el que había pasado hacía algunos minutos, pero había

cambiado mi forma de verlo”.

Yann Martel