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US Markets for Heart Valve Devices 2014

The US heart valve device market is large and growing, driven by the continued adoption and launch of THV devices, as well as an aging population.

This Medtech 360 Report provides comprehensive data and analysis on the current state of the market for heart valve devices in the US across a 10-year period.

Questions Answered in This Report:

* THV devices represent the most significant growth opportunities in the US heart valve device market .

Will TMVR replicate the initial success of TAVR in the US?

Which factors will drive adoption of these new devices?

What types of patients will be eligible for these procedures?

Is transcatheter treatment of the mitral valve likely to be done through repair or replacement?

* The US heart valve device market is dominated by four entrenched competitors .

In which market segments do new devices have the greatest opportunity to compete successfully?

Will US physicians readily switch from their current device brand usage?

What advantages in the market do these entrenched competitors have?

* Tissue heart valves and surgical annuloplasty repair devices face competition from THV devices .

How will the new transcatheter technologies affect the surgical repair and replacement markets?

When will transcatheter devices enter the market?

Scope:

Geographies Covered : US

Procedures Covered : Millennium Research Group's analysis uses the following breakdown of procedures:

image1

Notes : (1) *Other positions include the tricuspid and pulmonary valves. (2) **The product feature segmentation into stented, stentless, and sutureless applies to aortic xenografts only. (3) ***The product feature segmentation into with conduit and without conduit applies to aortic mechanical valves only.

Products Covered : Millennium Research Group's analysis uses the following breakdown of products in the market:

image2

Notes : (1) *The product feature segmentation into stented, stentless, and sutureless applies to aortic xenografts only. (2) **The product feature segmentation into with conduit and without conduit applies to aortic mechanical valves only.

Market Forecast Features : Based on primary research with industry professionals, Millennium Research Group uses its proprietary forecasting model to provide an in-depth examination of current and future trends in procedure volumes, unit sales, ASPs, and market values over a 10-year period (2012-2022).

Competitive Analysis : Millennium Research Group provides a detailed analysis of the competitive landscape and market shares for leading competitors.

Authors:

  • Ian Swanson

Contributors

  • John Fletcher
  • Karen Gierszewski
  • Samuli Heilala, M.Sc.
  • Andrew Koo
  • Veronica Ross

Table of Contents

TABLE OF CONTENTS

LIST OF FIGURES AND TABLES

EXECUTIVE SUMMARY

1 COUNTRY OVERVIEWS

  • 1.1 US
    • 1.1.1 Demographics and Economy
    • 1.1.2 Health Care System
    • 1.1.3 Regulatory Environment

2 CLINICAL LANDSCAPE

  • 2.1 Background
    • 2.1.1 Heart Anatomy
    • 2.1.2 Heart Valve Disease
  • 2.2 Procedure Descriptions
    • 2.2.1 Heart Valve Replacement
      • 2.2.1.1 Surgical Heart Valve Replacement
      • 2.2.1.2 Transcatheter Aortic Valve Replacement
    • 2.2.2 Heart Valve Repair
      • 2.2.2.1 Surgical Heart Valve Repair
      • 2.2.2.2 Transcatheter Mitral Valve Repair
  • 2.3 Competing Treatments
    • 2.3.1 Heart Valve Disease Medical Management
    • 2.3.2 Balloon Valvuloplasty
    • 2.3.3 Aortic Valve Bypass
  • 2.4 Guidelines and Diagnosis Patterns

3 PRODUCTS

  • 3.1 Heart Valve Replacement Devices
    • 3.1.1 Surgical Heart Valve Replacement Devices
      • 3.1.1.1 Tissue Heart Valves
        • 3.1.1.1.1 Xenograft Tissue Heart Valves
          • 3.1.1.1.1.1 By Product Feature
          • 3.1.1.1.1.2 By Material
        • 3.1.1.1.2 Allograft Tissue Heart Valves
      • 3.1.1.2 Mechanical Heart Valves
    • 3.1.2 Transcatheter Heart Valve Replacement Devices
      • 3.1.2.1 Transcatheter Aortic Valve Replacement Devices
      • 3.1.2.2 Transcatheter Pulmonary Valve Replacement Devices
      • 3.1.2.3 Transcatheter Mitral and Tricuspid Valve Replacement Devices
  • 3.2 Heart Valve Repair Devices
    • 3.2.1 Annuloplasty Devices
    • 3.2.2 Transcatheter Mitral Valve Repair Devices

4 CLINICAL TRIALS

  • 4.1 Tissue Heart Valve Trials
  • 4.2 Mechanical Heart Valve Trials
  • 4.3 Surgical Repair Device Clinical Trials
  • 4.4 Transcatheter Aortic Valve Replacement Device Trials
  • 4.5 Transcatheter Mitral Valve Repair Device Trials

5 HEART VALVE DEVICE MARKET

  • 5.1 Market Snapshot
  • 5.2 Detailed Market Analysis
  • 5.3 Competitive Snapshot
  • 5.4 Detailed Competitive Landscape
  • 5.5 Market Shares
  • 5.6 Recent Events
  • 5.7 Most Promising Emerging Products

6 HEART VALVE REPLACEMENT DEVICE MARKET

  • 6.1 Market Snapshot
  • 6.2 Detailed Market Analysis
    • 6.2.1 Surgical Heart Valve Replacement Devices
    • 6.2.2 Transcatheter Heart Valve Replacement Devices
  • 6.3 Competitive Snapshot
  • 6.4 Detailed Competitive Landscape
    • 6.4.1 Surgical Heart Valve Replacement Device Market
      • 6.4.1.1 Tissue Heart Valve Market
      • 6.4.1.2 Mechanical Heart Valve Market
    • 6.4.2 Transcatheter Heart Valve Replacement
  • 6.5 Market Shares

7 HEART VALVE REPAIR DEVICE MARKET

  • 7.1 Market Snapshot
  • 7.2 Detailed Market Analysis
    • 7.2.1 Surgical Annuloplasty Devices
    • 7.2.2 Transcatheter Mitral Valve Repair Devices
  • 7.3 Competitive Snapshot
  • 7.4 Detailed Competitive Landscape
    • 7.4.1 Annuloplasty Device Market
    • 7.4.2 Transcatheter Mitral Repair Device Market
  • 7.5 Market Shares

APPENDIX: METHODOLOGY

APPENDIX: ACRONYMS AND INITIALISMS

APPENDIX: BIBLIOGRAPHY

LIST OF FIGURES AND TABLES

TABLE OF CONTENTS

LIST OF FIGURES AND TABLES

EXECUTIVE SUMMARY

  • Figure 1: Heart Valve Device Market, by Product Type, US (USD), 2012-2022
  • Table 1: Heart Valve Device Market Landscape, US (USD), 2013 and 2022
  • Table 2: Heart Valve Device Market Leaders, by Product Type and Revenue, US, 2013
  • Table 3: Companies Mentioned
  • Table 4: Factors Impacting the Heart Valve Device Market, by Product Type, US
  • Table 5: Factors Impacting the Heart Valve Device Market, by Product Type, US
  • Table 6: Recent Novel Devices in the Heart Valve Device Market, US, 2013
  • Table 7: Expected Key Events in the Heart Valve Device Market, US
  • Table 8: Key Report Updates
  • Table 9: Heart Valve Device Procedures Covered, US
  • Table 10: ICD-9-CM Procedure Codes and Descriptions
  • Table 11: Heart Valve Devices Covered, US

1 COUNTRY OVERVIEWS

  • Table 12: Key Health and Economic Indicators, US

2 CLINICAL LANDSCAPE

  • Table 13: Heart Valve Device Procedures, by Procedure Type, Technique, and Product Type
  • Table 14: Competing Treatments
  • Figure 2: Treatment Providers and Referral Patterns
  • Table 15: Treatment Providers and Referral Patterns, by Treatment Phase
  • Figure 3: Recommendations for Heart Valve Devices, by Age Group

3 PRODUCTS

  • Table 16: Advantages and Disadvantages of Heart Valve Devices, by Product Type
  • Table 17: Heart Valve Replacement Device Functions, by Technique
  • Table 18: Advantages and Disadvantages of Surgical Heart Valve Replacement Devices, by Product Type
  • Table 19: Tissue Heart Valve Functions, by Material and Product Feature
  • Table 20: Advantages and Disadvantages of Tissue Heart Valves, by Material
  • Table 21: Advantages and Disadvantages of Xenograft Tissue Heart Valves, by Product Feature
  • Table 22: Advantages and Disadvantages of Xenograft Tissue Heart Valves, by Material
  • Table 23: Heart Valve Repair Device Functions, by Technique

4 CLINICAL TRIALS

  • Table 24: Porcine Tissue Valve Long-Term Durability Trial
  • Table 25: Pericardial Tissue Valve Long-Term Durability Trial
  • Table 26: Long Term Follow Up Study of the St. Jude Medical Trifecta Valve
  • Table 27: Freedom SOLO
  • Table 28: COMMENCE
  • Table 29: TRITON
  • Table 30: TRANSFORM
  • Table 31: Perceval S
  • Table 32: PROACT
  • Table 33: Very Long-Term Results (More Than 20 Years) of Valve Repair with Carpentier's Techniques in Nonrheumatic Mitral Valve Insufficiency
  • Table 34: Very Long-Term Survival and Durability of Mitral Valve Repair for Mitral Valve Prolapse
  • Table 35: Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Mitral Operation
  • Table 36: PARTNER
  • Table 37: Medtronic CoreValve U.S. Pivotal Trial
  • Table 38: SURTAVI
  • Table 39: PARTNER II
  • Table 40: Medtronic CoreValve REDO Study
  • Table 41: SAPIEN3
  • Table 42: Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve
  • Table 43: FRANCE 2 Registry
  • Table 44: SOURCE XT Registry
  • Table 45: TVT Registry
  • Table 46: Alternative Access Approaches for Transcatheter Aortic Valve Replace (TAVR) in Inoperable Patients With Aortic Stenosis (Inop AA)
  • Table 47: CLEAN-TAVI
  • Table 48: EVEREST II
  • Table 49: COAPT
  • Table 50: RESHAPE-HF

5 HEART VALVE DEVICE MARKET

  • Figure 4: Heart Valve Device Market, by Product Type, US (USD), 2012-2022
  • Figure 5: Heart Valve Device Procedures, by Position, US, 2012-2022
  • Table 51: Factors Impacting the Heart Valve Device Market, by Product Type, US
  • Table 52: Factors Impacting the Heart Valve Device Market, by Product Type, US
  • Table 53: Heart Valve Device Procedures, by Product Type, US, 2012-2022
  • Table 54: Heart Valve Device Procedures, by Position, US, 2012-2022
  • Table 55: Heart Valve Device Procedures, by Product Type, US, 2012-2022
  • Table 56: Aortic Heart Valve Device Procedures, by Product Type, US, 2012-2022
  • Table 57: Mitral Heart Valve Device Procedures, by Product Type, US, 2012-2022
  • Table 58: Mitral Heart Valve Device Procedures, by Product Type, US, 2012-2022
  • Table 59: Other Position Heart Valve Device Procedures, by Product Type, US, 2012-2022
  • Table 60: Other Position Heart Valve Device Procedures, by Product Type, US, 2012-2022
  • Table 61: Heart Valve Device Market, by Product Type, US (USD), 2012-2022
  • Table 62: Heart Valve Device Market Growth, by Product Type, US, 2013-2022
  • Table 63: Heart Valve Device Market, by Product Type, as a % of Total, US, 2012-2022
  • Table 64: Heart Valve Device Market, by Product Type, US (USD), 2012-2022
  • Table 65: Heart Valve Device Market Growth, by Product Type, US, 2013-2022
  • Table 66: Heart Valve Device Market, by Product Type, as a % of Total, US, 2012-2022
  • Figure 6: Leading Competitors in the Heart Valve Device Market, as a % of Total, US, 2013
  • Table 67: Leading Competitors in the Heart Valve Device Market, by Product Type, as a % of Total, US, 2013
  • Table 68: Leading Competitors in the Heart Valve Device Market, by Product Type, as a % of Total, US, 2013
  • Table 69: Recent Events in the Heart Valve Device Market, US
  • Table 70: Emerging Products in Development for the Heart Valve Device Market, US

6 HEART VALVE REPLACEMENT DEVICE MARKET

  • Figure 7: Heart Valve Replacement Device Market, by Technique, US (USD), 2012-2022
  • Figure 8: Heart Valve Replacement Device Market, by Product Type, US (USD), 2012-2022
  • Table 71: Heart Valve Replacement Device Procedures, by Position, US, 2012-2022
  • Table 72: Heart Valve Replacement Device Procedures, by Technique, US, 2012-2022
  • Table 73: Heart Valve Replacement Device Procedures, by Product Type, US, 2012-2022
  • Table 74: Aortic Heart Valve Replacement Device Procedures, by Technique, US, 2012-2022
  • Table 75: Aortic Heart Valve Replacement Device Procedures, by Product Type, US, 2012-2022
  • Table 76: Mitral Heart Valve Replacement Device Procedures, by Technique, US, 2012-2022
  • Table 77: Mitral Heart Valve Replacement Device Procedures, by Product Type, US, 2012-2022
  • Table 78: Other Position Heart Valve Replacement Device Procedures, by Product Type, US, 2012-2022
  • Table 79: Heart Valve Replacement Device Market, by Technique, US (USD), 2012-2022
  • Table 80: Heart Valve Replacement Device Market Growth, by Technique, US, 2013-2022
  • Table 81: Heart Valve Replacement Device Market, by Technique, as a % of Total, US, 2012-2022
  • Table 82: Heart Valve Replacement Device Market, by Product Type, US (USD), 2012-2022
  • Table 83: Heart Valve Replacement Device Market Growth, by Product Type, US, 2013-2022
  • Table 84: Heart Valve Replacement Device Market, by Product Type, as a % of Total, US, 2012-2022
  • Table 85: Surgical Heart Valve Replacement Device Procedures, by Position, US, 2012-2022
  • Table 86: Surgical Heart Valve Replacement Device Procedures, by Product Type, US, 2012-2022
  • Table 87: Aortic Surgical Heart Valve Replacement Device Procedures, by Product Type, US, 2012-2022
  • Table 88: Mitral Surgical Heart Valve Replacement Device Procedures, by Product Type, US, 2012-2022
  • Table 89: Other Position Surgical Heart Valve Replacement Device Procedures, by Product Type, US, 2012-2022
  • Table 90: Tissue Heart Valve Procedures, by Position, US, 2012-2022
  • Table 91: Tissue Heart Valve Procedures, by Material, US, 2012-2022
  • Table 92: Xenograft Tissue Heart Valve Procedures, by Position, US, 2012-2022
  • Table 93: Aortic Xenograft Tissue Heart Valve Procedures, by Product Feature, US, 2012-2022
  • Table 94: Allograft Tissue Heart Valve Procedures, by Position, US, 2012-2022
  • Table 95: Mechanical Heart Valve Procedures, by Position, US, 2012-2022
  • Table 96: Aortic Mechanical Heart Valve Procedures, by Product Feature, US, 2012-2022
  • Table 97: Surgical Heart Valve Replacement Device Market, by Product Type, US (USD), 2012-2022
  • Table 98: Surgical Heart Valve Replacement Device Market Growth, by Product Type, US, 2013-2022
  • Table 99: Surgical Heart Valve Replacement Device Market, by Product Type, as a % of Total, US, 2012-2022
  • Table 100: Tissue Heart Valve Market, by Material, US (USD), 2012-2022
  • Table 101: Tissue Heart Valve Market Growth, by Material, US, 2013-2022
  • Table 102: Tissue Heart Valve Market, by Material, as a % of Total, US, 2012-2022
  • Table 103: Xenograft Tissue Heart Valve Market, by Product Feature, US (USD), 2012-2022
  • Table 104: Xenograft Tissue Heart Valve Market Growth, by Product Feature, US, 2013-2022
  • Table 105: Xenograft Tissue Heart Valve Market, by Product Feature, as a % of Total, US, 2012-2022
  • Table 106: Mechanical Heart Valve Market, by Product Feature, US (USD), 2012-2022
  • Table 107: Mechanical Heart Valve Market Growth, by Product Feature, US, 2013-2022
  • Table 108: Mechanical Heart Valve Market, by Product Feature, as a % of Total, US, 2012-2022
  • Table 109: Aortic Mechanical Heart Valve Market, by Product Feature, US (USD), 2012-2022
  • Table 110: Aortic Mechanical Heart Valve Market Growth, by Product Feature, US, 2013-2022
  • Table 111: Aortic Mechanical Heart Valve Market, by Product Feature, as a % of Total, US, 2012-2022
  • Table 112: THV Replacement Device Procedures, by Product Type, US, 2012-2022
  • Table 113: THV Replacement Device Market, by Product Type, US (USD), 2012-2022
  • Table 114: THV Replacement Device Market Growth, by Product Type, US, 2013-2022
  • Table 115: THV Replacement Device Market, by Product Type, as a % of Total, US, 2012-2022
  • Figure 9: Leading Competitors in the Heart Valve Replacement Device Market, as a % of Total, US, 2013
  • Table 116: Leading Competitors in the Heart Valve Replacement Device Market, by Product Type, as a % Total, US, 2013

7 HEART VALVE REPAIR DEVICE MARKET

  • Figure 10: Heart Valve Repair Device Market, by Technique, US (USD), 2012-2022
  • Table 117: Heart Valve Repair Device Procedures, by Position, US, 2012-2022
  • Table 118: Heart Valve Repair Device Procedures, by Technique, US, 2012-2022
  • Table 119: Mitral Heart Valve Repair Device Procedures, by Technique, US, 2012-2022
  • Table 120: Heart Valve Repair Device Market, by Technique, US (USD), 2012-2022
  • Table 121: Heart Valve Repair Device Market Growth, by Technique, US, 2013-2022
  • Table 122: Heart Valve Repair Device Market, by Technique, as a % of Total, US, 2012-2022
  • Table 123: Surgical Annuloplasty Device Procedures, by Position, US, 2012-2022
  • Table 124: Surgical Annuloplasty Device Procedures, by Shape, US, 2012-2022
  • Table 125: Surgical Annuloplasty Device Market, by Shape, US (USD), 2012-2022
  • Table 126: Surgical Annuloplasty Device Market Growth, by Shape, US, 2013-2022
  • Table 127: Surgical Annuloplasty Device Market, by Shape, as a % of Total, US, 2012-2022
  • Table 128: TMVR Device Market, US (USD), 2012-2022
  • Figure 11: Leading Competitors in the Heart Valve Repair Device Market, as a % of Total, US, 2013
  • Table 129: Leading Competitors in the Heart Valve Repair Device Market, by Technique, as a % of Total, US, 2013

APPENDIX: METHODOLOGY

APPENDIX: ACRONYMS AND INITIALISMS

  • Table 130: Acronyms and Initialisms

APPENDIX: BIBLIOGRAPHY

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