MediPoint: Prosthetic Heart Valves - US Analysis and Market Forecasts




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The US prosthetic heart valves (PHV) market is a dynamic market that is expected to grow through 2020. This growth is driven by the rising prevalence of disease, an aging population, and the development of innovative next-generation devices. Recent advancements in the field of interventional cardiology have greatly improved clinical outcomes for patients. Prosthetic heart valves, including mechanical valves, tissue valves, and transcatheter valves, can be used to treat patients with valvular heart disease affecting the aortic or mitral valves. They can be delivered either via open-heart surgery or transcatheter aortic valve implantation (TAVR).

The report provides insights into the competitive landscape, the marketed and pipeline products, the current and emerging players and market analysis of the different device segments within the PHV market in the US. The report also provides insight into the unmet needs and an understanding of physician perceptions and decision-making process in using prosthetic heart valves. This report is built using data and information sourced from secondary sources and primary research interviews with leading Interventional Cardiologists, with in-house analysis conducted by GlobalDatas team of industry experts.


Key Questions Answered

  • What is the current and future prosthetic heart valves market outlook in the US? What trends are affecting the US PHV market?
  • Which are the key, high growth markets that valve manufacturers should expand into? Which markets are growing the fastest, and what are the top-selling products in each segment?
  • What are the unmet needs with PHVs currently on the market? How will emerging technologies such as repositionable and retrievable valves fulfill these unmet needs?
  • What clinical factors and technical specifications influence a physician to use one type of valve over another? What is physician perception and market outlook of PHV?
  • What are the challenges and complications of TAVR that have hindered widespread adoption?
  • With developing the next-generation of heart valves, what aspects of the technology are device manufacturers focused on optimizing? How will new entrants impact the PHV market?

Key Benefits

What Physicians Think quotes provide a unique insight into how healthcare professionals are reacting to events within the industry, and what their responses could mean for industry strategists. In this report you will understand the perceptions of leading Interventional Cardiologists and Cardiac Surgeons from around the world. This information is essential for all strategic decision makers in every organization allowing them to act on high quality information.


  • Overview of valvular heart disease, including anatomy, epidemiology, pathophysiology, symptoms, diagnosis, and treatment guidelines and modalities.
  • Annualized total PHV market revenue from 2011-2020 including adoption patterns in the US.
  • Key topics covered include strategic competitor assessment, market characterization, identification of unmet needs, reimbursement and regulatory considerations, and implications for the PHV market.
  • Pipeline analysis: Comprehensive list of products split across different stages of development, emerging trends and valve designs in development, including investigation of delivery and deployment methods, materials and coatings used, and sizes available.
  • Analysis of the current and future market competition in the US PHV market. Insightful review of the key industry drivers, opportunities, barriers and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

  • Understand the trends shaping and driving the US PHV market.
  • Realize device preferences of physicians who have performed the tests already.
  • Access market sizing, forecasts and quantified growth opportunities in US PHV market through 2018.
  • Quantify candidate patient populations to better design product pricing & launch plans.
  • Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
  • Perform benchmarking analysis of growth opportunities against currently marketed products.
  • Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
  • Take a comprehensive look at the markets device pipeline and identify promising, paradigm-shifting products.
  • Create an effective counter-strategy to gain a competitive advantage against those currently in the market.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.
  • Whats the next big thing in US PHV market landscape? Identify, understand and capitalize.
Table of Contents

1 Table of Contents
1.1 List of Tables
1.2 List of Figures

2 Introduction
2.1 Anatomy
2.2 Epidemiology
2.3 Related Reports

3 Industry Overview
3.1 Overview
3.1.1 Mechanical Heart Valves
3.1.2 Tissue Heart Valves
3.1.3 Transcatheter Heart Valves
3.2 Indications
3.2.1 Valvular Stenosis
3.2.2 Valvular Regurgitation
3.3 Clinical Presentation
3.3.1 Diagnosis
3.3.2 Risk Assessment Tools
3.4 Clinical Outcomes
3.4.1 Treatment Options
3.4.2 Life Style Changes
3.4.3 Complications
3.5 Applications of Technology
3.6 Market Access
3.6.1 Purchasing Decisions
3.7 Influence of Clinical Trials
3.8 Brand Loyalty
3.9 Adoption
3.10 Regulation
3.11 Reimbursement
3.12 Procedure Trends
3.13 Regulatory Issues/Recalls
3.13.1 Portico TAVR Implants Halted Due to Safety Concerns
3.14 M&A, Key Partnerships
3.14.1 Licensing Agreement Between Symetis and Endoluminal Sciences
3.14.2 Manufacturing Agreement Between Sorin Group and Boston Scientific
3.15 Economic Impact
3.15.1 Indirect Costs
3.15.2 Direct Costs

4 Unmet Needs
4.1 Delivery & Implantation
4.1.1 Mechanism of Deployment
4.1.2 Anchoring
4.1.3 Retrievability
4.1.4 Repositionability
4.1.5 Artery Accessibility
4.1.6 Rapid Pacing
4.1.7 Coronary Ostia Occlusion
4.1.8 Motorized Delivery Systems
4.2 Performance
4.2.1 Durability
4.2.2 Thrombogenicity
4.2.3 Effective Orifice Area
4.2.4 Coefficient of Friction
4.3 Crimping
4.5 Replaceable Leaflets
4.6 Embolic Protection
4.7 Pacemaker Placement

5 Market Opportunity Analysis
5.1 Overview
5.2 Emerging Markets for TAVR
5.3 Increasing Tissue Valve Lifespan
5.4 Valve-in-Valve Procedures (Re-replacement)
5.5 Transcatheter Mitral Valve Replacement
5.6 Balloon Valvuloplasty

6 Market Drivers and Barriers
6.1 Driver: Rising Disease Prevalence
6.2 Driver: Multimodality Imaging
6.3 Driver: Alternative Access Routes
6.4 Driver: Lower Risk Patient Access
6.5 Driver: Patient Demand and Awareness
6.6 Driver: Advanced Computational Tools
6.7 Driver: Rising Competition and Innovation
6.8 Barrier: High Device and Procedure Cost
6.9 Barrier: Burden of Rising Regulation
6.10 Barrier: Medical Device Excise Tax
6.11 Barrier: Proving Long-Term Efficacy
6.12 Substitute: Valve Repair
6.13 Substitute: Balloon Valvuloplasty

7 Competitive Assessment
7.1 Overview
7.2 Classification Based on Features
7.2.1 Mechanical Heart Valves
7.2.2 Tissue Heart Valves
7.2.3 Transcatheter Heart Valves
7.3 Market Dynamics Analysis
7.4 Product Profiles
7.4.1 Mechanical Heart Valves
7.4.2 Tissue Heart Valves
7.4.3 Transcatheter Heart Valves

8 Pipeline Assessment
8.1 Overview
8.2 Product Profiles
8.2.1 Cytograft Tissue Valve (Cytograft Tissue Engineering)
8.2.2 Centera Valve (Edwards Lifesciences)
8.2.3 Colibri Heart Valve (Colibri Heart Valve)
8.2.4 Cormove (Perouse Medical)
8.2.5 Endovalve (Micro Interventional Devices)
8.2.6 HLT Transcatheter Valve System (Heart Leaflet Technology)
8.2.7 Inovare Valve (Braile Biomdica)
8.2.8 Kalangos Valve (Leman Cardiovascular)
8.2.9 Tiara Valve (Neovasc)
8.2.10 Trinity Valve (Transcatheter Technologies GmbH)
8.2.11 Vanguard Exchangeable Heart Valve System (ValveXchange)

9 Clinical Trials to Watch
9.1 Overview
9.2 CoreValve Evolut R (Medtronic)
9.3 TRANSFORM Trial - Intuity Valve System (Edwards Lifesciences)
9.4 PROACT Trial - On-X Plus 1.5 Mechanical Heart Valve (On-X Life Technologies)
9.5 PARTNER II Trial - Sapien XT (Edwards Lifesciences)
9.6 PARTNER III Trial - Sapien 3 (Edwards Lifesciences)
9.7 REPRISE III IDE/PMA Trial - Lotus Valve System (Boston Scientific)
9.8 SENTINEL-H Trial - Sentinel Cerebral Protection System (Claret Medical)

10 Current and Future Players
10.1 Overview
10.2 Trends in Corporate Strategy
10.3 Company Profiles
10.3.1 AorTech International
10.3.2 Boston Scientific
10.3.3 Braile Biomdica
10.3.4 CardiAQ Valve Technologies
10.3.5 Claret Medical
10.3.6 Colibri Heart Valve
10.3.7 Cytograft Tissue Engineering
10.3.8 Direct Flow Medical
10.3.9 Edwards Lifesciences
10.3.10 Heart Leaflet Technologies
10.3.11 JenaValve Technology
10.3.12 Leman Cardiovascular
10.3.13 Micro Interventional Devices
10.3.14 Neovasc
10.3.15 On-X Life Technologies, Inc
10.3.16 Perouse Medical
10.3.17 Sorin Group
10.3.18 St Jude Medical
10.3.19 Symetis
10.3.20 Transcatheter Technologies GmbH
10.3.21 TTK Healthcare
10.3.22 ValveXchange

11 Strategic Competitive Assessment
11.1 Company Market Share

12 Market Outlooks

13 Appendix.
13.1 Bibliography
13.2 Abbreviations
13.3 Report Methodology
13.3.1 Overview
13.3.2 Coverage
13.3.3 Secondary Research
13.4 Forecasting Methodology
13.5 Physicians and Specialists Included in This Study
13.6 About the Authors
13.6.1 Analysts
13.6.2 Global Head of Healthcare
13.7 About GlobalData
13.8 Disclaimer

Table 1: Overview of Symptoms, Risk Factors, and Treatments
Table 2: Evolution of the Mechanical Heart Valve
Table 3: Evolution of the Tissue Heart Valve
Table 4: Comparison of Surgical and Transcatheter Procedures
Table 5: NYHA Functional Classification of Cardiac Disease Patients
Table 6: Drug Treatment Paradigm for Aortic Valve Disease
Table 8: Medicare National Average of Inpatient Hospital Reimbursement for Valve Replacement, 2014-2015
Table 9: ICD-9 Coding Guide for Valvular Heart Disease, 2014
Table 10: Forecast Indirect National Costs For Aortic Valve Disease in the US ($bn), 2011-2020
Table 12: Minimum Arterial Diameter Required for TAVR Systems
Table 13: Global Projected Prevalence of Aortic Stenosis, 2013-2020
Table 14: Current Access Routes for Transcatheter Aortic Valve Replacement
Table 15: Mechanical Heart Valves, SWOT Analysis, 2014
Table 16: Marketed Mechanical Heart Valve Products, 2014
Table 17: Tissue Heart Valves, SWOT Analysis, 2014
Table 18: Marketed Tissue Heart Valve Products, 2014
Table 19: Transcatheter Heart Valves, SWOT Analysis, 2014
Table 20: Marketed Transcatheter Heart Valve Products, 2014
Table 21: Product Profile - Carbomedics Standard Aortic Mechanical Valve (Sorin Group)
Table 22: Carbomedics Standard Aortic Mechanical Valve, SWOT Analysis, 2014
Table 23: Product Profile - Open Pivot Mechanical Valve (Medtronic)
Table 24: Open Pivot Mechanical Valve, SWOT Analysis, 2014
Table 25: Product Profile - On-X Mechanical Heart Valve (On-X Life Technologies)
Table 26: On-X Mechanical Heart Valve, SWOT Analysis, 2014
Table 27: Product Profile - On-X Plus 1.5 Mechanical Heart Valve (On-X Life Technologies)
Table 28: On-X Plus 1.5 Mechanical Heart Valve, SWOT Analysis, 2014
Table 29: Product Profile - Regent Valve (St Jude Medical)
Table 30: Regent Valve, SWOT Analysis, 2014
Table 31: Product Profile - Carpentier-Edwards Perimount Pericardial Valve (Edwards Lifesciences)
Table 32: Carpentier-Edwards Perimount Pericardial Valve, SWOT Analysis, 2014
Table 33: Product Profile - 3f Enable Sutureless Aortic Bioprosthesis (Medtronic)
Table 34: 3f Enable Sutureless Aortic Bioprosthesis, SWOT Analysis, 2014
Table 35: Product Profile - Hancock II (Medtronic)
Table 36: Medtronic Hancock II, SWOT Analysis, 2014
Table 37: Product Profile - Mitroflow Aortic Pericardial Heart Valve (Sorin Group)
Table 38: Sorin Group Mitroflow Aortic Pericardial Heart Valve, SWOT Analysis, 2014
Table 39: Product Profile - Trifecta Heart Valve (St Jude Medical)
Table 40: St Jude Medical Trifecta Heart Valve, SWOT Analysis, 2014
Table 41: Product Profile - Acurate TA/Acurate neo (Symetis)
Table 42: Acurate TA/Acurate neo, SWOT Analysis, 2014
Table 43: Product Profile - Lotus Valve System (Boston Scientific)
Table 44: Boston Scientific Lotus Valve System, SWOT Analysis, 2014
Table 45: Product Profile - Direct Flow Medical Transcatheter Valve (Direct Flow Medical)
Table 46: Direct Flow Medical Valve, SWOT Analysis, 2014
Table 47: Product Profile - Sapien XT Valve (Edwards Lifesciences)
Table 48: Sapien XT Valve, SWOT Analysis, 2014
Table 49: Product Profile - JenaValve (JenaValve Technology)
Table 50: JenaValve, SWOT Analysis, 2014
Table 51: Product Profile - CoreValve (Medtronic)
Table 52: CoreValve, SWOT Analysis, 2014
Table 53: Product Profile - CoreValve Evolut R (Medtronic)
Table 54: CoreValve Evolut R, SWOT Analysis, 2014
Table 55: Product Profile - Portico Valve (St Jude Medical)
Table 56: Portico Valve, SWOT Analysis, 2014
Table 57: Product Profile - Cytograft Tissue Valve (Cytograft Tissue Engineering)
Table 58: Cytograft Tissue Valve, SWOT Analysis, 2014
Table 59: Product Profile - Centera Valve (Edwards Lifesciences Corporation)
Table 60: Centera Valve, SWOT Analysis, 2014
Table 61: Product Profile - Colibri Heart Valve (Colibri Heart Valve)
Table 62: Colibri Heart Valve, SWOT Analysis, 2014
Table 63: Product Profile - Cormove (Perouse Medical)
Table 64: Cormove, SWOT Analysis, 2014
Table 65: Product Profile - Endovalve (Micro Interventional Devices)
Table 66: Endovalve, SWOT Analysis, 2014
Table 67: Product Profile - HLT Transcatheter Valve System (Heart Leaflet Technology)
Table 68: HLT Transcatheter Valve System, SWOT Analysis, 2014
Table 69: Product Profile - Inovare Valve (Braile Biomdica)
Table 70: Inovare Valve, SWOT Analysis, 2014
Table 71: Product Profile - Kalangos Valve (Leman Cardiovascular)
Table 72: Kalangos Valve, SWOT Analysis, 2014
Table 73: Product Profile - Tiara Valve (Neovasc.)
Table 74: Tiara Valve, SWOT Analysis, 2014
Table 75: Product Profile - Trinity Valve (Transcatheter Technologies GmbH)
Table 76: Trinity VALVE, SWOT Analysis, 2014
Table 77: Product Profile - Vanguard Exchangeable Heart Valve System (ValveXchange)
Table 78: Vanguard Exchangeable Heart Valve System, SWOT Analysis, 2014
Table 79: AorTech International plc, Company Profile, 2014
Table 80: AorTech International, SWOT Analysis, 2014
Table 81: Boston Scientific Corporation, Company Profile, 2014
Table 82: Boston Scientific Corporation, SWOT Analysis, 2014
Table 83: Braile Biomdica, Company Profile, 2014
Table 84: Braile Biomdica, SWOT Analysis, 2014
Table 85: CardiAQ Valve Technologies, Company Profile, 2014
Table 86: CardiAQ Valve Technologies, SWOT Analysis, 2014
Table 87: Claret Medical, Inc., Company Profile, 2014
Table 88: Claret Medical, SWOT Analysis, 2014
Table 89: Colibri Heart Valve, LLC, Company Profile, 2014
Table 90: Colibri Heart Valve, SWOT Analysis, 2014
Table 91: Cytograft Tissue Engineering, Inc., Company Profile, 2014
Table 92: Cytograft Tissue Engineering, SWOT Analysis, 2014
Table 93: Direct Flow Medical, Inc., Company Profile, 2014
Table 94: Direct Flow Medical, SWOT Analysis, 2014
Table 95: Edwards Lifesciences Corporation, Company Profile, 2014
Table 96: Edwards Lifesciences, SWOT Analysis, 2014
Table 97: Heart Leaflet Technologies, Company Profile, 2014
Table 98: Heart Leaflet Technologies, SWOT Analysis, 2014
Table 99: JenaValve Technology, Company Profile, 2014
Table 100: JenaValve Technology, SWOT Analysis, 2014
Table 101: Leman Cardiovascular, Company Profile, 2014
Table 102: Leman Cardiovascular, SWOT Analysis, 2014
Table 103: Micro Interventional Devices, Inc., Company Profile, 2014
Table 104: Micro Interventional Devices, SWOT Analysis, 2014
Table 105: Neovasc, Inc., Company Profile, 2014
Table 106: Neovasc, SWOT Analysis, 2014
Table 107: On-X Life Technologies, Inc., Company Profile, 2014
Table 108: On-X Life Technologies, SWOT Analysis, 2014
Table 109: Perouse Medical, Company Profile, 2014
Table 110: Perouse Medical, SWOT Analysis, 2014
Table 111: Sorin Group, Company Profile, 2014
Table 112: Sorin Group, SWOT Analysis, 2014
Table 113: St Jude Medical, Inc., Company Profile, 2014
Table 114: St Jude Medical, Inc., SWOT Analysis, 2014
Table 115: Symetis, Company Profile, 2014
Table 116: Symetis, SWOT Analysis, 2014
Table 117: Transcatheter Technologies GmbH, Company Profile, 2014
Table 118: Transcatheter Technologies, SWOT Analysis, 2014
Table 119: TTK Healthcare, Company Profile, 2014
Table 120: TTK Healthcare, SWOT Analysis, 2014
Table 121: ValveXchange, Inc., Company Profile, 2014
Table 122: ValveXchange, SWOT Analysis, 2014
Table 123:US Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011-2020

Figure 1: Hierarchy of Valvular Heart Disease
Figure 2: Operative Risk for Severe, Symptomatic Aortic Valve Disease Patients, 2009
Figure 3: US Procedure Volume Forecast by Market Segment, 2011-2020
Figure 4: US Procedure Volume Comparison by Market Segment, 2013 & 2020
Figure 5: US Company Market Shares for Prosthetic Heart Valves, 2012
Figure 6: US Market Value Forecast by Market Segment, $m, 2011-2020
Figure 7: US Market Value Comparison by Market Segment, 2013 & 2020
Figure 8: US Average Selling Price by Market Segment, 2011-2020