CURRENT AND EMERGING U.S. MARKETS FOR MYOCARDIAL REVASCULARIZATION, REPAIR, AND REGENERATION PRODUCTS AND THERAPIES

305 Pages | 59 Exhibits | 2013 Analysis | Forecasts Through 2016

OVERVIEW:
Heart disease is the leading cause of death in the United States (U.S.), killing one person nearly every minute. Coronary heart disease-a group of disorders that result in a reduction in blood flow through the heart-affects approximately 16 million people in the U.S., while an estimated 670,000 new cases of heart failure are diagnosed each year.

This dynamic, new report from Medtech Insight includes analyses of products, current and emerging markets, competitors, and opportunities in the fields of myocardial revascularization and repair and regeneration. Within this market, the U.S. segment for myocardial revascularization products is projected to reach an estimated value of $2.3 billion in the year 2016. This segment, as covered by the scope of this report, includes atherosclerosis management biotherapies, drug-eluting balloons, drug-eluting coronary stents (including bioresorbable drug-eluting stents), facilitated anastomosis systems, and transmyocardial revascularization systems.

This report also provides an analysis and forecast for myocardial repair and regeneration products (including cell-based and gene-based therapies and devices for cardiac structural support and modification).

In addition, a clinical overview is provided that includes updated incidence and prevalence statistics for the most common heart diseases and disorders.

TABLE OF CONTENTS:
EXECUTIVE SUMMARY

i. Current and Emerging Markets for Selected Myocardial Revascularization Products and Technologies 
	a. Facilitated Anastomosis Devices 
	b. Drug-Eluting Balloon Angioplasty Systems 
	c. Drug-Eluting Stent Systems 
	d. Bioresorbable Drug-Eluting Stent Systems 
	e. Transmyocardial Revascularization Systems 
	f. Atherosclerosis Management Biotherapy Products 
	g. Combined Market Forecast for Myocardial Revascularization Products 
ii. Current and Emerging Markets for Selected Myocardial Repair/Regeneration Products and Technologies 
	a. Cell-Based Therapies for Myocardial Tissue Repair/Regeneration 
	b. Gene-Based Technologies for Myocardial Tissue Repair/Regeneration 
	c. Cardiac Structural Support/Modification Products 
iii. Methodology 

Exhibit ES-1: Current and Emerging Myocardial Revascularization Products,  Combined Market Forecast, 2011-2016 
Exhibit ES-2: Cell-Based Myocardial Tissue Repair/Regeneration, Potential Procedure Volumes, 2011-2016 
Exhibit ES-3: 2013, Selected Gene-Based Myocardial Tissue Repair/Regeneration Approaches Under Investigation 

1. OVERVIEW OF HEART DISEASES AND DISORDERS

1.1 Heart Anatomy and Physiology 
	1.1.1 The Cardiac Conduction System 
	1.1.2 The Heart Valves 
1.2 Selected Heart Diseases/Disorders 
	1.2.1 Coronary Heart Disease 
		1.2.1.1 Atherosclerosis 
		1.2.1.2 Angina Pectoris 
		1.2.1.3 Myocardial Infarction 
	1.2.2 Hypertension 
		1.2.2.1 Prehypertension 
	1.2.3 Cardiac Dysrhythmia 
		1.2.3.1 Bradycardia 
		1.2.3.2 Sick Sinus Syndrome 
		1.2.3.3 Heart Block 
		1.2.3.4 Atrial Fibrillation 
		1.2.3.5 Tachycardia 
		1.2.3.6 Ventricular Fibrillation 
	1.2.4 Cardiomyopathy 
		1.2.4.1 Dilated Cardiomyopathy 
		1.2.4.2 Hypertrophic Cardiomyopathy 
		1.2.4.3 Restrictive Cardiomyopathy 
	1.2.5 Heart Valve Disorders 
		1.2.5.1 Valvular Stenosis 
		1.2.5.2 Valvular Regurgitation 
		1.2.5.3 Valve Prolapse 
	1.2.6 Heart Failure 
		1.2.6.1 Disease Development 
		1.2.6.2 Classification/Staging Systems 

Exhibit 1-1: Cross-Section Diagram of the Heart 
Exhibit 1-2: Cross-Section Diagram of the Heart Valves 
Exhibit 1-3: Statistics for Selected Heart Disease Risk Factors 
Exhibit 1-4: Standard Angina Pectoris Classification 
Exhibit 1-5: Angina Pectoris, Selected Statistics 
Exhibit 1-6: Myocardial Infarction, Selected Statistics 
Exhibit 1-7: 2011, Percentage of Adults Who Have Been Told They Have High Blood Pressure, by State 
Exhibit 1-8: Hypertension, Selected Statistics 
Exhibit 1-9: Cardiac Dysrhythmia, Selected Statistics 
Exhibit 1-10: Cardiomyopathy, Selected Statistics 
Exhibit 1-11: Heart Valve Disorders, Selected Statistics 
Exhibit 1-12: Heart Failure, Selected Statistics 
Exhibit 1-13: Summary, New York Heart Association Heart Failure Classification System 
Exhibit 1-14: Summary, American College of Cardiology/American Heart Association Heart Failure Staging System 
Exhibit 1-15: Patient Breakdown Based on New York Heart Association and American College of Cardiology/American Heart Association Heart Failure Classifications 

2. CURRENT AND EMERGING MYOCARDIAL REVASCULARIZATION PROCEDURES AND THERAPIES

2.1 Coronary Artery Bypass Graft Surgery 
	2.1.1 Conventional Coronary Artery Bypass Graft Surgery 
	2.1.2 Less Invasive Coronary Artery Bypass Graft Surgery 
		2.1.2.1 Minimally Invasive Direct Coronary Artery Bypass 
		2.1.2.2 Robotic-Assisted Coronary Artery Bypass 
		2.1.2.3 Off-Pump Coronary Artery Bypass 
		2.1.2.4 Port Access Coronary Artery Bypass 
		2.1.2.5 Hybrid Coronary Artery Bypass 
	2.1.3 Complications/Efficacy 
	2.1.4 Procedure Volumes 
2.2 Facilitated Anastomosis 
	2.2.1 Benefits Compared to Conventional Suturing 
	2.2.2 Technologies 
	2.2.3 Procedure Volumes 
2.3 Percutaneous Transluminal Coronary Angioplasty 
	2.3.1 Approaches 
	2.3.2 Applications 
	2.3.3 Complications/Efficacy 
	2.3.4 Procedure Volumes 
2.4 Drug-Eluting Balloon Angioplasty 
	2.4.1 Clinical Trials 
		2.4.1.1 Studies Involving the Paccocath Drug-Eluting Balloon 
		2.4.1.2 Studies Involving the SeQuent Please Drug-Eluting Balloon 
	2.4.2 Regulatory Outlook for Drug-Eluting Balloons 
2.5 Coronary Stenting 
	2.5.1 Stenting with Bare-Metal and Drug-Eluting Devices 
		2.5.1.1 Stent Materials 
			2.5.1.1.1 Stainless Steel 
			2.5.1.1.2 Nitinol 
			2.5.1.1.3 Tantalum 
			2.5.1.1.4 Cobalt-Chromium Alloys 
		2.5.1.2 Drug-Eluting Stents 
			2.5.1.2.1 Stent Coatings/Surfaces and Anti-Restenosis Agents 
				2.5.1.2.1.1 Sirolimus 
				2.5.1.2.1.2 Paclitaxel 
				2.5.1.2.1.3 Everolimus 
				2.5.1.2.1.4 Zotarolimus 
				2.5.1.2.1.5 Tacrolimus 
				2.5.1.2.1.6 Biolimus A9 
				2.5.1.2.1.7 Pimecrolimus 
		2.5.1.3 Drug Delivery Techniques 
		2.5.1.4 Stent Delivery 
		2.5.1.5 Stent Deployment 
		2.5.1.6 Indications 
			2.5.1.6.1 Patients with Small Vessel Disease 
			2.5.1.6.2 Patients with Left Main Disease 
		2.5.1.7 Complications/Efficacy 
			2.5.1.7.1 Repeat Revascularization 
			2.5.1.7.2 Stent Thrombosis 
			2.5.1.7.3 Diabetes and Stenting 
			2.5.1.7.4 Stent-Associated ST-Segment Elevation Myocardial Infarction 
			2.5.1.7.5 Long Lesion Length and Restenosis 
		2.5.1.8 Procedure Volumes 
			2.5.1.8.1 Drug-Eluting Stents 
			2.5.1.8.2 Bare-Metal Stents 
	2.5.2 Stenting with Bioabsorbable Devices 
		2.5.2.1 The Absorb Bioresorbable Vascular Scaffold  (Abbott Vascular/Abbott Laboratories) 
		2.5.2.2 The Absorbable Metal Stent (Biotronik) 
		2.5.2.3 The ReZolve Stent (REVA Medica) 
		2.5.2.4 Procedure Volumes 
	2.5.3 Stenting with Biological Material-Carrying Devices 
		2.5.3.1 Endothelial Progenitor Cell Capture Antibodies 
2.6 Alternative Anti-Restenotic Technologies Under Development 
	2.6.1 Anti-Restenotic Gene Therapy 
	2.6.2 Therapeutic Angiogenesis 
		2.6.2.1 Growth Factor-Based Therapy 
		2.6.2.2 Stem Cell-/Progenitor Cell-Based Therapy 
2.7 Transmyocardial Revascularization 
	2.7.1 Laser-Based Transmyocardial Revascularization 
	2.7.2 Indications 
	2.7.3 Procedure Volumes 
2.8 Atherosclerosis Management Biotherapies 
	2.8.1 Caseload Volumes 
2.9 Combined Procedure Volumes Forecast 

Exhibit 2-1: Advantages and Disadvantages of Conventional and Selected Minimally Invasive Coronary Artery Bypass Techniques 
Exhibit 2-2: Coronary Artery Bypass Graft Surgery, Procedure Volumes Forecast, 2011-2016 
Exhibit 2-3: Advantages and Disadvantages of Facilitated Anastomosis Systems 
Exhibit 2-4: Facilitated Anastomosis Performed in Conjunction with Coronary Artery Bypass Graft Surgery, Procedure Volumes Forecast, 2011-2016 
Exhibit 2-5: Advantages and Disadvantages of Conventional Percutaneous Transluminal Coronary Angioplasty and Stenting Compared to Coronary Artery Bypass Graft Surgery 
Exhibit 2-6: Percutaneous Transluminal Coronary Angioplasty, Procedure Volumes Forecast, 2011-2016 
Exhibit 2-7: Pooled 24-Month Follow-Up Data for the PACCOCATH-ISR I/II Trials 
Exhibit 2-8: Six-Month Follow-Up Data for the PEPCAD I-SVD Trial 
Exhibit 2-9: Six-Month Follow-Up Data for the PEPCAD II-ISR Trial 
Exhibit 2-10: Key Findings from the PICCOLETO and PEPCAD-CTO Studies with Drug-Eluting Balloon Treatment of De Novo Lesions 
Exhibit 2-11: Selected Anti-Restenosis Agents Used in Drug-Eluting Stents 
Exhibit 2-12: Advantages and Disadvantages of Drug Carriers for Drug-Eluting Stents 
Exhibit 2-13: Coronary Stenting, Procedure Volumes Forecast, 2011-2016 
Exhibit 2-14: Bioabsorbable Coronary Stents, Selected Clinical Data 
Exhibit 2-15: Bioabsorbable Drug-Eluting Coronary Stenting, Procedure Volumes Forecast, 2011-2016 
Exhibit 2-16: Advantages and Disadvantages of Growth Factor- and Stem Cell-Based Therapeutic Angiogenesis 
Exhibit 2-17: Transmyocardial Revascularization, Procedure Volumes Forecast, 2011-2016 
Exhibit 2-18: Atherosclerosis Management Biotherapies, Caseload Volumes Forecast, 2011-2016 
Exhibit 2-19: Current and Emerging Myocardial Revascularization Procedures and Therapies, Combined Procedure Volumes Forecast, 2011-2016 

3. CURRENT AND EMERGING MYOCARDIAL REPAIR/REGENERATION TECHNOLOGIES

3.1 Cell-Based Myocardial Tissue Repair/Regeneration Technologies 
	3.1.1 Cell Graft Sources 
	3.1.2 Cell Therapy Delivery Methods 
	3.1.3 Clinical Experience with Stem Cell-Based Myocardial Tissue Repair/Regeneration Technologies 
3.2 Gene-Based Myocardial Tissue Repair/Regeneration Technologies 
	3.2.1 Therapeutic Approaches 
3.3 Cardiac Structural Support and Modification Technologies 
	3.3.1 Myocardial Support 
	3.3.2 Surgical Ventricular Restoration 

Exhibit 3-1: Selected Cell Types Under Investigation for Myocardial Tissue Repair and Regeneration 

4. CURRENT AND EMERGING MARKETS FOR SELECTED MYOCARDIAL REVASCULARIZATION PRODUCTS

4.1 Facilitated Anastomosis Devices 
	4.1.1 Products 
			4.1.1.1.1 Cardica 
			4.1.1.1.2 MAQUET Cardiovascular/Getinge Group 
			4.1.1.1.3 Medtronic 
			4.1.1.1.4 Vitalitec International 
	4.1.2 Market Forecast 
	4.1.3 Competitive Analysis 
4.2 Drug-Eluting Balloon Angioplasty Systems 
	4.2.1 Products 
	4.2.2 Market Forecast 
4.3 Drug-Eluting Stent Systems 
	4.3.1 Products 
		4.3.1.1 Emerging Technologies 
			4.3.1.1.1 Boston Scientific 
			4.3.1.1.2 CID (Carbostent & Implantable Devices) 
			4.3.1.1.3 Medtronic 
	4.3.2 Market Forecast 
	4.3.3 Competitive Analysis 
4.4 Bioresorbable Drug-Eluting Stent Systems 
	4.4.1 Products 
		4.4.1.1 Abbott Vascular/Abbott Laboratories 
		4.4.1.2 Biotronik 
		4.4.1.3 Elixir Medical 
		4.4.1.4 REVA Medical 
	4.4.2 Market Forecast 
4.5 Transmyocardial Laser Revascularization Systems 
	4.5.1 Products 
	4.5.2 Market Forecast 
	4.5.3 Competitors 
4.6 Atherosclerosis Management Biotherapy 
	4.6.1 Products 
		4.6.1.1 High-Density Lipoprotein-Boosting Biotherapies 
			4.6.1.1.1 Esperion Therapeutics 
			4.6.1.1.2 Eli Lilly 
			4.6.1.1.3 The Medicines Company 
			4.6.1.1.4 Merck 
			4.6.1.1.5 Roche Pharmaceuticals/F. Hoffmann-La Roche 
		4.6.1.2 Inflammatory Process-Targeting Biotherapies 
			4.6.1.2.1 Anthera Pharmaceuticals 
			4.6.1.2.2 GlaxoSmithKline 
			4.6.1.2.3 Via Pharmaceuticals 
	4.6.2 Market Forecast 
4.7 Combined Market Forecast for Myocardial Revascularization Products 

Exhibit 4-1: 2013, Selected Facilitated Anastomosis Devices for Cardiac Applications 
Exhibit 4-2: Facilitated Anastomosis Devices Used in Coronary Artery Bypass Graft Surgery, Market Forecast, 2011-2016 
Exhibit 4-3: 2011, Market for Facilitated Anastomosis Devices Used in Coronary Artery Bypass Graft Surgery, Share by Supplier 
Exhibit 4-4: 2013, Selected Drug-Eluting Balloon Catheters for Coronary Indications 
Exhibit 4-5: 2013, Selected Drug-Eluting Coronary Stents 
Exhibit 4-6: 2013, Selected Drug-Eluting Coronary Stents Under Development 
Exhibit 4-7: Drug-Eluting Coronary Stents, Market Forecast, 2011-2016 
Exhibit 4-8: 2011, Drug-Eluting Coronary Stents Market, Share by Supplier 
Exhibit 4-9: 2013, Selected Bioabsorbable Drug-Eluting Coronary Stents Under Development 
Exhibit 4-10: Bioabsorbable Drug-Eluting Coronary Stents, Market Forecast, 2011-2016 
Exhibit 4-11: 2013, Selected Transmyocardial Laser Revascularization Products 
Exhibit 4-12: Transmyocardial Laser Revascularization Products, Market Forecast, 2011-2016 
Exhibit 4-13: 2011, Transmyocardial Laser Revascularization Products Market, Share by Supplier 
Exhibit 4-14: 2013, Selected Atherosclerosis Management Biotherapies Under Development 
Exhibit 4-15: Atherosclerosis Management Biotherapy Products, Market Forecast, 2011-2016 
Exhibit 4-16: Current and Emerging Myocardial Revascularization Products,  Combined Market Forecast, 2011-2016 

5. CURRENT AND EMERGING MARKETS FOR SELECTED MYOCARDIAL REPAIR/REGENERATION PRODUCTS

5.1 Selected Cell-Based Myocardial Repair/Regeneration Technologies Under Development 
	5.1.1 Aastrom Biosciences 
	5.1.2 Advanced Cell Technology 
	5.1.3 Amorcyte/NeoStem 
	5.1.4 Athersys 
	5.1.5 Baxter Healthcare/Baxter International 
	5.1.6 Bioheart 
	5.1.7 Capricor 
	5.1.8 Cardio3 BioSciences 
	5.1.9 Cytomedix 
	5.1.10 Cytori Therapeutics 
	5.1.11 Geron and BioTime 
	5.1.12 Mesoblast 
	5.1.13 Osiris Therapeutics 
	5.1.14 Terumo 
	5.1.15 Market Status 
5.2 Selected Gene-Based Myocardial Repair/Regeneration Technologies Under Development 
	5.2.1 AnGes MG 
	5.2.2 Baylor College of Medicine, Stony Brook University Medical Center, and Weill Cornell Medical College 
	5.2.3 Cardium Therapeutics 
	5.2.4 Celladon 
	5.2.5 Center for Translational Medicine/Thomas Jefferson University 
	5.2.6 Harvard Medical School 
	5.2.7 LoneStar Heart 
	5.2.8 Renova Therapeutics 
	5.2.9 University of Pittsburgh Medical Center 
	5.2.10 Market Status 
5.3 Selected Myocardial Support and Remodeling Devices and Technologies Under Development 
	5.3.1 BioVentrix 
	5.3.2 CorAssist Cardiovascular 
	5.3.3 LoneStar Heart 
	5.3.4 Surgical Ventricular Restoration Devices 
	5.3.5 Market Analysis 

Exhibit 5-1: 2013, Selected Cell-Based Myocardial Repair/Regeneration Therapies Under Development 
Exhibit 5-2: Cell-Based Myocardial Tissue Repair/Regeneration, Potential Procedure Volumes, 2011-2016 
Exhibit 5-3: 2013, Selected Gene-Based Myocardial Tissue Repair/Regeneration Therapies Under Development 
Exhibit 5-4: 2013, Selected Ventricular Support and Remodeling Devices and Technologies Under Development 
Exhibit 5-5: The Mannequin Surgical Ventricular Restoration System 

6. COMPANY PROFILES

6.1 Abbott Laboratories 
6.2 Baxter International, Inc. 
6.3 Boston Scientific Corporation 
6.4 Cardica, Inc. 
6.5 Cardiogenesis Corporation/CryoLife, Inc. 
6.6 Medtronic, Inc. 

APPENDIX:  COMPANY LISTING


COMPANIES COVERED:

  1. Aachen Resonance GmbH
  2. Aastrom Biosciences, Inc.
  3. Abbott Vascular/Abbott Laboratories
  4. Advanced Cell Technology, Inc.
  5. Amorcyte, Inc./NeoStem, Inc.
  6. AnGes MG, Inc.
  7. Anthera Pharmaceuticals, Inc.
  8. Athersys, Inc.
  9. B. Braun Melsungen AG
  10. Baxter Healthcare Corporation/Baxter International, Inc.
  11. Bioheart, Inc.
  12. Biosense Webster, Inc./Johnson & Johnson
  13. Biosensors International Group LTD
  14. BioTime, Inc.
  15. Biotronik GmbH & Company KG
  16. BioVentrix, Inc.
  17. Blue Medical Devices BV
  18. Boston Scientific Corporation
  19. Capricor, Inc.
  20. Cardica, Inc.
  21. Cardio3 BioSciences SA
  22. Cardiogenesis Corporation/CryoLife, Inc.
  23. Cardium Therapeutics, Inc.
  24. Celladon Corporation
  25. Chase Medical, Inc.
  26. CID S.p.a.
  27. CorAssist Cardiovascular LTD
  28. Cordis Corporation/Johnson & Johnson
  29. CryoLife, Inc.
  30. CV Ingenuity/Covidien PLC
  31. Cytomedix, Inc.
  32. Cytori Therapeutics, Inc.
  33. Eli Lilly and Company
  34. Elixir Medical Corporation
  35. Esperion Therapeutics, Inc.
  36. Ethicon, Inc./Johnson & Johnson
  37. Eurocor GmbH/Opto Circuits India LTD
  38. Genzyme Corporation/Sanofi SA
  39. Geron Corporation
  40. GlaxoSmithKline PLC
  41. Grupo Vitalmex SA de CV
  42. InspireMD, Inc.
  43. Johnson & Johnson
  44. Kensey Nash Corporation/Royal DSM NV
  45. Lincoln Park Capital LLC
  46. LoneStar Heart, Inc.
  47. Lonza Group LTD
  48. Lutonix, Inc./C.R. Bard, Inc.
  49. Madrigal Pharmaceuticals, Inc.
  50. MAQUET Cardiovascular/Getinge Group
  51. Medrad, Inc./Bayer AG
  52. Medtronic, Inc.
  53. Merck & Company, Inc.
  54. Mesoblast LTD
  55. Micell Technologies, Inc.
  56. Mytogen, Inc./Advanced Cell Technology, Inc.
  57. Novadaq Technologies, Inc.
  58. Novartis Pharmaceuticals Corporation/Novartis AG
  59. OrbusNeich Co. LTD
  60. Osiris Therapeutics, Inc.
  61. Pfizer, Inc.
  62. Renova Therapeutics, Inc.
  63. REVA Medical, Inc.
  64. Roche Group/F. Hoffmann-La Roche LTD
  65. Sahajanand Medical Technologies Pvt LTD
  66. St. Jude Medical, Inc.
  67. SuturTek, Inc.
  68. Tepha, Inc.
  69. Terumo Corporation
  70. Teva Pharmaceutical Industries LTD
  71. The Medicines Company
  72. TissueGen, Inc.
  73. Vitalitec International, Inc./Vitalitec Surgical Group
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