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Abiomed, Inc
Berlin Heart GmbH
Bioheart, Inc
Cytori Therapeutics, Inc
Getinge/Maquet Cardiovascular/Datascope
Osiris Therapeutics, Inc
Teleflex Medical/Arrow International
Thoratec Corporation
EXECUTIVE SUMMARY
Technology
Epidemiology and Applications
Product Markets
Intra-Aortic Balloon Pumps
Percutaneous Ventricular Assist Devices
External Ventricular Assist Devices
Cell Therapies
Companies
Summary Exhibit 1: Comparison of Major Acute Cardiac Assist Devices
Summary Exhibit 2: Conditions and Situations Potentially Requiring Acute Cardiac Assist
Summary Exhibit 3: Penetration of Selected Applications for Acute Cardiac Assist Devices, 2008-2015
Summary Exhibit 4: Acute Cardiac Assist Devices, Market Forecast by Type, 2008-2015
Summary Exhibit 5: Potential Roll Out of Cell Therapy Market for AMI
Summary Exhibit 6: Suppliers of Acute Cardiac Assist Devices by Type, 2009
1.0 OVERVIEW AND EPIDEMIOLOGY
1.1 Revascularization
1.1.1 High Risk Percutaneous Coronary Intervention
1.1.2 High Risk Cardiac Surgery
1.1.2.1 Difficulty Weaning from Cardiopulmonary Bypass
1.1.2.2 Postcardiotomy Cardiogenic Shock
1.1.2.3 Other High Risk Cardiac Surgery
1.2 Post-AMI Cardiogenic Shock
1.3 Refractory Unstable Angina
1.4 Heart Failure
1.4.1 Classification Systems
1.4.2 Etiology
14.3 Incidence and Prevalence
1.4.4 Acute Decompensation
1.5 Acute Myocarditis
1.6 High Risk AMI
Exhibit 1-1: Conditions and Situations Potentially Requiring Acute Cardiac Assist
Exhibit 1-2: Revascularizations by Type, Procedure Forecast, 2008-2013
Exhibit 1-3: High Risk PCI, Procedure Forecast, 2008-2015
Exhibit 1-4: Patients Having Difficulty Weaning from CPB, 2008-2015
Exhibit 1-5: Postcardiotomy Shock, Procedure Forecast, 2008-2015
Exhibit 1-6: Other High Risk CABG Surgery, Patient Forecast, 2008-2015
Exhibit 1-7: Hospitalizations for AMI, Patient Forecast, 1998-2015
Exhibit 1-8: Post-AMI Cardiogenic Shock, Patient Forecast, 2008-2015
Exhibit 1-9: Patients with Refractory Unstable Angina Potentially Requiring Acute Cardiac Assist, 2008-2015
Exhibit 1-10: Normal versus Enlarged Heart
Exhibit 1-11: NYHA Functional Classification of Heart Failure
Exhibit 1-12: ACC/AHA Classification of Heart Failure
Exhibit 1-13: Etiology of Heart Failure
Exhibit 1-14: Demographics and Concomitant Diseases Associated with Acute Heart Failure Syndromes in Three Registries
Exhibit 1-15: Summary of U.S. Heart Failure Epidemiology, 2006
Exhibit 1-16: U.S. Heart Failure Patients by Gender, 2008-2015
Exhibit 1-17: Heart Failure Prevalence by NYHA Classification, 2008-2015
Exhibit 1-18: Hospitalizations for Heart Failure, Total versus Primary, 2008-2015
Exhibit 1-19: Hospitalizations for Acute Myocarditis, 2008 – 2015
Exhibit 1-20: High Risk AMI, Hospital Admissions, 2008 – 2015
2.0 INTRA-AORTIC BALLOON PUMPS
2.1 Technology and Usage
2.2 Indications and Contraindications
2.2.1 Cardiac Assist Benchmark Outcomes Registry
2.2.2 Benchmark 2 Registry
2.2.3 BCIS-1
2.2.4 CRISP-AMI Trial
2.3 Potential Complications
2.4 Product Trends
2.5 Products and Suppliers
2.5.1 Abiomed
2.5.2 Getinge/Maquet Cardiovascular/Datascope
2.5.3 Teleflex Medical/Arrow International
2.6 Market Analysis
2.6.1 Applications
2.6.2 Market Forecast
2.6.3 Supplier Shares
Exhibit 2-1: Placement and Operation of Intra-Aortic Balloon Catheter
Exhibit 2-2: Indications & Contraindications for IABP Therapy
Exhibit 2-3: Benchmark Registry: Indications for IABP Therapy
Exhibit 2-4: Benchmark Registry: Complications Associated with IABP Therapy
Exhibit 2-5: Selected IABP Consoles and Balloon Catheters, 2009
Exhibit 2-6: Abiomed's iPulse IAB and Console
Exhibit 2-7: Maquet Cardiovascular CS300 Controller and Sensation 7F Catheter
Exhibit 2-8: Arrow International AutoCAT 2 WAVE and FiberOptix Catheter
Exhibit 2-9: Anatomy of Teleflex/Arrow ProActive CounterPulsation
Exhibit 2-10: IABP Targeted Applications, Procedure Forecast, 2008-2015
Exhibit 2-11: IABP Controllers and Balloon Catheters, Market Forecast, 2008-2015
Exhibit 2-12 IABP Products, Supplier Shares, 2009
3.0 PERCUTANEOUS ACUTE ASSIST DEVICES
3.1 Technology
3.2 Indications and Contraindications
3.3 Products and Suppliers
3.3.1 Abiomed
3.3.1.1 Impella 2.5
3.3.1.2 Impella LD and 5.0
3.3.1.3 Impella Mobile Console
3.3.2 A-Med Systems
3.3.3 CardiacAssist
3.3.4 CardioBridge
3.3.5 ECP GmbH
3.3.6 Levitronix
3.3.7 Lifebridge Medizintechnik GmbH
3.3.8 Orqis Medical
3.3.9 PulseCath
3.4 Market Analysis
3.4.1 Applications
3.4.2 Market Forecast
3.4.3 Supplier Shares
Exhibit 3-1: Indications and Contraindications for pVADs
Exhibit 3-2: Selected Percutaneous Ventricular Assist Products, 2009
Exhibit 3-3: Abiomed's Impella 2.5 pVAD
Exhibit 3-4: Abiomed's Impella LD and 5.0 pVADs
Exhibit 3-5: A-Med Systems' pLVAD
Exhibit 3-6: CardiacAssist TandemHeart System
Exhibit 3-7: CardioBridge Reitan Catheter Pump
Exhibit 3-8: ECP GmbH’s Expandable Catheter Pump
Exhibit 3-9: Levitronix CentriMag VAS
Exhibit 3-10: Lifebridge System
Exhibit 3-11: Orqis Medical's Cancion System
Exhibit 3-12: Orqis Exceleras System
Exhibit 3-13: PulseCath's iVac 3L
Exhibit 3-14: pVADs, Targeted Applications, Procedure Forecast, 2008-2015
Exhibit 3-15: pVADs, Market Forecast, 2008-2015
Exhibit 3-16: pVADs, Supplier Shares, 2008 & 2009
4.0 EXTERNAL ACUTE RECOVERY VADS
4.1 VAD Types
4.1.1 Pump Placement
4.1.2 Pump/Flow Type
4.2 Clinical Indications
4.3 Products and Suppliers
4.3.1 Abiomed
4.3.1.1 Blood Pumps
4.3.1.2 Cannulae
4.3.1.3 Driver Consoles
4.3.2 Berlin Heart
4.3.2.1 EXCOR
4.3.2.2 EXCOR Pediatric
4.3.2.3 Driver Consoles
4.3.3 Thoratec
4.3.3.1 Thoratec PVAD
4.3.3.2 Thoratec IVAD
4.3.3.3 Driver Consoles
4.4 Procedure Forecast
4.5 Market Forecast
4.6 Supplier Shares
Exhibit 4-1: Overview of VAD Indications
Exhibit 4-2: External Acute Recovery VAD Products and Suppliers, 2009
Exhibit 4-3: Abiomed's VAD Products
Exhibit 4-4: Berlin Heart's VAD Products
Exhibit 4-5: Thoratec's External VAD Products
Exhibit 4-6: External Acute Recovery VADs, Procedure Forecast, 2008-2015
Exhibit 4-7: External Acute Recovery VADs, Market Forecast, 2008-2015
Exhibit 4-8: External Acute Recovery VADs, Supplier Shares, 2008
5.0 CELL THERAPY
5.1 Rationale for Therapy
5.2 Process and Technology
5.3 Cell Sources
5.3.1 Embryonic Stem Cells
5.3.2 Adult Stem Cells
5.3.2.1 Adipose Tissue-Derived Stem Cells
5.3.2.2 Resident Cardiac Progenitor Cells
5.3.2.3 Umbilical Cord Blood Cells
5.3.2.4 Skeletal Myoblasts
5.3.2.5 Induced Pluripotent Stem Cells
5.4 Cell Delivery
5.5 Mechanisms of Action
5.6 Suppliers and Programs
5.6.1 Angioblast Systems
5.6.2 Bioheart
5.6.3 Cardium Therapeutics
5.6.4 Cytori Therapeutics
5.6.5 Osiris Therapeutics
5.6.6 Stempeutics
5.6.7 TCA Cellular Therapy
5.6.8 University Programs
5.6.8.1 J.W. Goethe University
5.6.8.2 Rikshospitalet University Hospital
5.6.8.3 Combination Therapy Programs
5.7 Market Opportunity
Exhibit 5-1: Circulation and Mobilization of Progenitor Cells
Exhibit 5-2: Mobilization of Progenitor Cells Following AMI
Exhibit 5-3: Cell Therapy Process and Associated Devices
Exhibit 5-4: Sources of Stem Cells
Exhibit 5-5: Methods of Cell Delivery for Cardiac Implantation
Exhibit 5-6: Comparison of Cell Delivery Approaches
Exhibit 5-7: Mechanisms of Action of Cardiac Cell Therapy
Exhibit 5-8: Cell Therapy Products and Approaches Targeting Infarct Reduction in Acute Myocardial Infarction, 2009
Exhibit 5-9: Selected Clinical Outcomes of Angioblast's Revascor MPC therapy
Exhibit 5-10: TGI 1200 Adipose Tissue Processing System
Exhibit 5-11: Frequency of Stem Cells in Adipose Tissue versus Bone Marrow
Exhibit 5-12: Cytori Therapeutics Celution System
Exhibit 5-13: Osiris Therapeutics' Prochymal for Acute Myocardial Infarction
Exhibit 5-14: Selected University Programs Targeting Stem Cell Therapy for Acute Myocardial Infarction, 2009
Exhibit 5-15: MAGIC Cell Trial and Supporting Studies Targeting Treatment of Acute Myocardial Infarction
Exhibit 5-16: Other Combination Therapy Clinical Trials Targeting Treatment of Acute Myocardial Infarction
Exhibit 5-17: Stem Cell Therapy Targeting Acute Myocardial Infarction, Addressable Market, 2008-2015
Exhibit 5-18: Stem Cell Therapy Targeting Acute Myocardial Infarction, Forecast Market by Product Type, Years 1 through 5
6.0 COMPANY PROFILES
6.1 Abiomed, Inc
6.2 Berlin Heart GmbH
6.3 Bioheart, Inc
6.4 Cytori Therapeutics, Inc
6.5 Getinge/Maquet Cardiovascular/Datascope
6.6 Osiris Therapeutics, Inc
6.7 Teleflex Medical/Arrow International
6.8 Thoratec Corporation