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  1. Aastrom Biosciences, Inc.
  2. Abbott Diagnostics/ Abbott Laboratories Corporation
  3. Abiomed, Inc.
  4. Advanced Cell Technology, Inc.
  5. Aldagen, Inc.
  6. Alere, Inc.
  7. Amorcyte, Inc./NeoStem, Inc.
  8. AnGes MG, Inc.
  9. Applied Cardiac Systems, Inc.
  10. Athersys, Inc.
  11. Baxter Healthcare Corporation/ Baxter International, Inc.
  12. Bayer AG
  13. Beckman Coulter, Inc./ Danaher Corporation
  14. Berlin Heart GmbH
  15. BG Medicine, Inc.
  16. Bioheart, Inc.
  17. bioMérieux, Inc.
  18. Biotronik SE & Co. KG
  19. BioVentrix, Inc.
  20. Boston Scientific Corporation
  21. CardiacAssist, Inc.
  22. Cardio3 BioSciences SA
  23. Cardiomedics, Inc.
  24. Cardium Therapeutics, Inc.
  25. Celladon Corporation
  26. Chase Medical, Inc.
  27. CircuLite, Inc.
  28. Covidien plc
  29. Cytori Therapeutics, Inc.
  30. Dualis MedTech GmbH/ AVRA Surgical, Inc.
  31. Epoch Biosciences, Inc./ ELITech Group
  32. Estech, Inc.
  33. Evaheart Medical USA, Inc./ Sun Medical Technology Research Corporation
  34. Geron Corporation
  35. HeartWare International, Inc.
  36. Insightra Medical, Inc.
  37. Jarvik Heart, Inc.
  38. LVAD Technology
  39. Maquet GmbH & Co. KG/ Getinge Group
  40. Medtronic, Inc.
  41. Mesoblast LTD
  42. MicroMed Cardiovascular, Inc.
  43. Ortho-Clinical Diagnostics, Inc./ Johnson & Johnson
  44. Osiris Therapeutics, Inc.
  45. Paracor Medical, Inc.
  46. Progenitor Cell Therapy LLC/ NeoStem, Inc.
  47. Response Biomedical Corporation
  48. Roche Diagnostics/ F. Hoffmann-La Roche LTD
  49. ScottCare Corporation/ Scott Fetzer Company/ Berkshire Hathaway, Inc.
  50. Siemens Healthcare/Siemens AG
  51. Sorin Group
  52. St. Jude Medical, Inc.
  53. Sunshine Heart, Inc.
  54. SynCardia Systems, Inc.
  55. Teleflex, Inc.
  56. Terumo Heart, Inc./ Terumo Corporation
  57. Teva Pharmaceutical Industries LTD
  58. Thoratec Corporation
  59. Vasomedical, Inc.
  60. Vical, Inc.
  61. World Heart Corporation
Market Reports


U.S. MARKETS FOR CURRENT AND EMERGING TECHNOLOGIES FOR THE TREATMENT OF HEART FAILURE


256 Pages | 54 Exhibits | 2012 Analysis | Forecasts Through 2016




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Demographics, the aging of the population, and accompanying rates of heart failure are the main drivers of the United States (U.S.) market for heart failure-specific diagnostic and therapeutic technologies. In the U.S., approximately 6.6 million adults age 18 and older (or 2.8% of the population) have heart failure, and it is estimated that by the year 2030, an additional 3.0 million people will have the disease, representing a 25.0% increase in prevalence. The condition is the most common Medicare diagnosis-related group (i.e., hospital discharge diagnosis), and more Medicare dollars are spent for the diagnosis and treatment of heart failure than for any other diagnosis.

In 2010, U.S. sales of heart failure-specific diagnostic and therapeutic technologies totaled approximately $3,193.8 million; over the forecast period covered by this report, this market is expected to increase in value at a compound annual rate of 2.8%, with sales reaching an estimated $3,683.6 million in the year 2016.

This dynamic new report from Medtech Insight includes analyses of products, markets, competitors, and opportunities in the area of heart failure-specific diagnostic and therapeutic technologies. The market segments that are covered by this report include B-type natriuretic peptide immunoassays, cardiac resynchronization therapy devices, mechanical circulatory support systems (including ventricular assist devices, intra-aortic balloon pumps, counterpulsation systems, and total artificial hearts), surgical ventricular restoration devices, and emerging cell and gene-based therapeutic technologies aimed at myocardial repair and regeneration.





EXECUTIVE SUMMARY

i. Clinical Overview 
ii. B-Type Natriuretic Peptide Testing Products 
	a. Market Forecast 
iii. Heart Failure Therapeutic Devices 
	a. Cardiac Resynchronization Therapy Devices 
	b. Mechanical Circulatory Support Devices 
	c. Surgical Ventricular Restoration Products 
	d. Market Forecast 
iv. Emerging Cell- and Gene-Based Myocardial Tissue Repair/Regeneration Products 
	a. Cell-Based Myocardial Tissue Repair/Regeneration Technologies 
		i. Market Forecast 
	b. Gene-Based Myocardial Tissue Repair/Regeneration Technologies 
v. Combined Market Forecast 

Exhibit ES-1: United States Population, by Selected Ages, 1990-2050 
Exhibit ES-2: Heart Failure-Related B-Type Natriuretic Peptide Testing Products, Market Forecast, 2010-2016 
Exhibit ES-3: Heart Failure Therapeutic Devices, Market Forecast, 2010-2016 
Exhibit ES-4: Cell-Based Myocardial Tissue Repair/Regeneration Products, Market Forecast, 2010-2016 
Exhibit ES-5: Heart Failure-Specific Diagnostic and Therapeutic Technologies, Combined Market Forecast, 2010-2016 

1. OVERVIEW OF HEART FAILURE

1.1 Anatomy and Physiology of the Heart 
1.2 Heart Failure Etiology 
1.3 Diseases/Disorders Associated with the Development of Heart Failure 
	1.3.1 Coronary Artery Disease and Acute Myocardial Infarction 
	1.3.2 Hypertension 
	1.3.3 Cardiomyopathy 
		1.3.3.1 Dilated Cardiomyopathy 
		1.3.3.2 Hypertrophic Cardiomyopathy 
		1.3.3.3 Restrictive Cardiomyopathy 
	1.3.4 Valvular Heart Disease 
	1.3.5 Cardiac Dysrhythmias 
		1.3.5.1 Atrial Fibrillation 
		1.3.5.2 Bradycardia 
		1.3.5.3 Heart Block 
		1.3.5.4 Tachycardia 
		1.3.5.5 Ventricular Fibrillation 
1.4 Epidemiology and Economic Impact of Heart Failure 

Exhibit 1-1: New York Heart Association Classification System for Heart Failure 
Exhibit 1-2: Summary, American College of Cardiology/American Heart Association Heart Failure Staging System 
Exhibit 1-3: Patient Breakdown Based on New York Heart Association and American College of Cardiology/American Heart Association Heart Failure Classifications 
Exhibit 1-4: Incidence, Prevalence, Mortality, and Hospital Discharges for Conditions Associated with the Onset of Heart Failure 
Exhibit 1-5: Heart Failure Facts and Figures 

2. HEART FAILURE DIAGNOSIS

2.1 Initial Evaluation 
	2.1.1 Patient History and Physical Examination 
	2.1.2 Laboratory Testing 
		2.1.2.1 Natriuretic Peptide Testing 
	2.1.3 Electrocardiography 
		2.1.3.1 Resting Electrocardiography 
		2.1.3.2 Holter Monitoring 
		2.1.3.3 Exercise Stress Testing 
2.2 Diagnostic Imaging 
	2.2.1 X-Ray-Based Imaging 
		2.2.1.1 Conventional X-Ray-Based Imaging 
		2.2.1.2 Angiography 
	2.2.2 Computed Tomography 
	2.2.3 Magnetic Resonance Imaging 
	2.2.4 Nuclear Medicine Imaging 
	2.2.5 Ultrasound Imaging 

Exhibit 2-1: Primary Clinical Goals of Heart Failure Diagnostic Modalities 
Exhibit 2-2: Medical Conditions Associated with Elevated B-Type Natriuretic Peptide Levels 

3. B-TYPE NATRIURETIC PEPTIDE TESTING PRODUCTS MARKET

3.1 Approved Indications for B-Type Natriuretic Peptide Testing 
3.2 Clinical Trials 
3.3 Reimbursement 
3.4 Guidelines for the Management of Heart Failure 
3.5 Selected B-Type Natriuretic Peptide Testing Products for Heart-Failure Related Applications 
3.6 Procedure Volumes Forecast 
3.7 Market Forecast 
	3.7.1 Market Drivers 
	3.7.2 Market Limiters 
3.8 Competitive Analysis 

Exhibit 3-1: Approved Clinical Applications for Heart Failure-Related Natriuretic Peptide Testing 
Exhibit 3-2: B-Type Natriuretic Peptide Cut-Off/Scaling Levels for the Differentiation of Heart Failure and Non-Heart Failure Patients 
Exhibit 3-3: Correlation of B-Type Natriuretic Peptide Levels with New York Heart Association Heart Failure Classes 
Exhibit 3-4: Proposed Algorithms for Interpretation of Natriuretic Peptide Levels in Patients Presenting with Acute Dyspnea 
Exhibit 3-5: 2012, Selected Heart Failure-Related B-Type Natriuretic Peptide Assays 
Exhibit 3-6: B-Type Natriuretic Peptide Testing, Procedure Volumes Forecast, 2010-2016 
Exhibit 3-7: Heart Failure-Related B-Type Natriuretic Peptide Testing Products, Market Forecast, 2010-2016 
Exhibit 3-8: 2010, Heart Failure-Related B-Type Natriuretic Peptide Testing Products Market, Share by Supplier 

4. HEART FAILURE THERAPEUTIC DEVICES MARKET

4.1 Cardiac Resynchronization Therapy Devices 
	4.1.1 Clinical Trials 
	4.1.2 Indications and Contraindications 
	4.1.3 Products 
	4.1.4 Procedure Volumes 
	4.1.5 Market Forecast 
	4.1.6 Competitive Analysis 
4.2 Mechanical Circulatory Support Systems 
	4.2.1 Ventricular Assist Devices 
		4.2.1.1 Device Types 
			4.2.1.1.1 External Ventricular Assist Devices 
			4.2.1.1.2 Internal Ventricular Assist Devices 
			4.2.1.1.3 Percutaneous Ventricular Assist Devices 
			4.2.1.1.4 Pulsatile Flow Ventricular Assist Devices 
			4.2.1.1.5 Continuous Flow VentricularAssist Devices 
		4.2.1.2 Indications 
		4.2.1.3 Device and Patient Selection 
		4.2.1.4 Products 
		4.2.1.5 Procedure Volumes 
		4.2.1.6 Market Forecast 
		4.2.1.7 Competitive Analysis 
	4.2.2 Intra-Aortic Balloon Pumps 
		4.2.2.1 Technology Overview 
		4.2.2.2 Indications and Contraindications 
		4.2.2.3 Products 
		4.2.2.4 Procedure Volumes 
		4.2.2.5 Market Forecast 
		4.2.2.6 Competitive Analysis 
	4.2.3 Counterpulsation Systems 
		4.2.3.1 Clinical Trials 
		4.2.3.2 Indications and Contraindications 
		4.2.3.3 Products 
		4.2.3.4 Procedure Volumes 
		4.2.3.5 Market Forecast 
		4.2.3.6 Competitive Analysis 
		4.2.3.7 Implantable Counterpulsation Systems 
			4.2.3.7.1 Implantable Intra-Aortic Counterpulsation Systems 
			4.2.3.7.2 Implantable Extra-Aortic Counterpulsation Systems 
			4.2.3.7.3 Plausible Market for Implantable Counterpulsation Systems 
	4.2.4 Total Artificial Hearts 
		4.2.4.1 Clinical Experience 
		4.2.4.2 Total Artificial Heart Indications and Potential Patient Caseloads 
		4.2.4.3 Products 
		4.2.4.4 Market Analysis 
4.3 Surgical Ventricular Restoration 
	4.3.1 Products 
	4.3.2 Market Analysis 
4.4 Combined Procedure Volumes Forecast 
4.5 Combined Market Forecast 

Exhibit 4-1: Summary, Recommended Heart Failure Treatment Regimens, by Stage and Class 
Exhibit 4-2: Indications and Contraindications for Cardiac Resynchronization Therapy 
Exhibit 4-3: 2012, Selected Cardiac Resynchronization Therapy Devices 
Exhibit 4-4: Cardiac Resynchronization Therapy Device Implants, Procedure Volumes Forecast, 2010-2016 
Exhibit 4-5: Cardiac Resynchronization Therapy Devices, Market Forecast, 2010-2016 
Exhibit 4-6: 2010, Cardiac Resynchronization Therapy Devices Market, Share by Supplier 
Exhibit 4-7: Advantages and Disadvantages of Pulsatile and Continuous Flow Ventricular Assist Devices 
Exhibit 4-8: 2012, Selected Ventricular Assist Devices 
Exhibit 4-9: 2012, Selected Ventricular Assist Devices Under Development 
Exhibit 4-10: Ventricular Assist Device Placement, Procedure Volumes Forecast, 2010-2016 
Exhibit 4-11: Ventricular Assist Devices, Market Forecast, 2010-2016 
Exhibit 4-12: 2010, Ventricular Assist Devices Market, Share by Supplier 
Exhibit 4-13: Indications and Contraindications for Intra-Aortic Balloon Pump Therapy 
Exhibit 4-14: 2012, Selected Intra-Aortic Balloon Pump Consoles and Catheters 
Exhibit 4-15: Intra-Aortic Balloon Pump Therapy, Procedure Volumes Forecast, 2010-2016 
Exhibit 4-16: Intra-Aortic Balloon Pump Systems, Market Forecast, 2010-2016 
Exhibit 4-17: 2010, Intra-Aortic Balloon Pump Systems Market, Share by Supplier 
Exhibit 4-18: Indications and Contraindications for External Counterpulsation Therapy 
Exhibit 4-19: 2012, Selected External Counterpulsation Systems 
Exhibit 4-20: External Counterpulsation, Procedure Volumes Forecast, 2010-2016 
Exhibit 4-21: External Counterpulsation Systems, Market Forecast, 2010-2016 Exhibit 4-22: 2010, External Counterpulsation Systems Market, Share by Supplier 
Exhibit 4-23: 2012, Selected Implantable Counterpulsation Systems Under Development 
Exhibit 4-24: 2012, Selected Total Artificial Heart Systems 
Exhibit 4-25: Total Artificial Heart Implantation,Procedure Volumes Forecast, 2010-2016 
Exhibit 4-26: Total Artificial Heart Systems, Market Forecast, 2010-2016 
Exhibit 4-27: 2012, Features of Chase Medical’s Surgical Ventricular Restoration Device 
Exhibit 4-28: Surgical Ventricular Reconstruction, Market and Procedure Volumes Forecast, 2010-2016 
Exhibit 4-29: Device-Based Heart Failure Therapy, Combined Procedure Volumes Forecast, 2010-2016 
Exhibit 4-30: Heart Failure Therapeutic Devices, Combined Market Forecast, 2010-2016 

5. EMERGING CELL- AND GENE-BASED MYOCARDIAL TISSUE REPAIR/REGENERATION PRODUCTS MARKET

5.1 Cell-Based Myocardial Tissue Repair/Regeneration Technologies 
	5.1.1 Cell Graft Sources 
	5.1.2 Administration of Cell Therapy 
	5.1.3 Clinical Experience with Stem Cell-Based Myocardial Tissue Repair/Regeneration Technologies
	5.1.4 Selected Cell-Based Myocardial Repair/Regeneration Technologies Under Development 
		5.1.4.1 Aastrom Biosciences 
		5.1.4.2 Advanced Cell Technology 
		5.1.4.3 Aldagen 
		5.1.4.4 Amorcyte/NeoStem 
		5.1.4.5 Baxter Healthcare/Baxter International 
		5.1.4.6 Bioheart 
		5.1.4.7 Cardio3 BioSciences 
		5.1.4.8 Cytori Therapeutics 
		5.1.4.9 Geron 
		5.1.4.10 Mesoblast 
		5.1.4.11 Osiris Therapeutics 
5.2 Gene-Based Myocardial Tissue Repair/Regeneration Technologies 
	5.2.1 Gene Therapy Technologies Under Development for the Treatment of Heart Failure 
		5.2.1.1 AnGes MG 
		5.2.1.2 Cardium Therapeutics 
		5.2.1.3 Celladon 
		5.2.1.4 Center for Translational Medicine/Thomas Jefferson University 
		5.2.1.5 Southwestern Medical Center/University of Texas 
		5.2.1.6 University of Pittsburgh Medical Center 
5.3 Emerging Market for Cell-Based Myocardial Repair/Regeneration Products 

Exhibit 5-1: Advantages and Disadvantages of Selected Cell Grafts for Myocardial Repair/Regeneration 
Exhibit 5-2: 2012, Selected Cell-Based Myocardial Repair/Regeneration Therapies Under Development 
Exhibit 5-3: 2012, Selected Gene-Based Myocardial Tissue Repair/Regeneration Therapies Under Development 
Exhibit 5-4: Cell-Based Myocardial Tissue Repair/Regeneration Products, Market Forecast, 2010-2016 

6. COMPANY PROFILES

6.1 Alere, Inc. 
6.2 Chase Medical, Inc. 
6.3 Maquet GmbH/Getinge Group AB 
6.4 Medtronic, Inc. 
6.5 Mesoblast LTD 
6.6 SynCardia Systems, Inc. 
6.7 Thoratec Corporation 
6.8 Vasomedical, Inc. 

APPENDIX:  COMPANY LISTING 

Published by Medtech Insight and distributed exclusively by LSI



This report is listed in the following markets:
Biomaterials, Biotechnology, Cardiovascular, Diagnostics, Imaging, Surgery, Vascular and Wound Management