The US heart valve device market is the largest in the world and it continues to grow rapidly, due largely to the swift adoption of THV devices and an aging population. Clinical  investigations continue to generate positive results and propel the THV market forward; large companies, in particular, are vying to secure and expand their market share by launching clinical trials and targeting small companies with innovative devices for acquisition to add new, cutting-edge THV devices to their portfolios. Furthermore, novel devices and device types will continue to emerge in the coming years and access new patient populations, generating continued growth in this market. However, the COVID-19 global pandemic will have a significant impact on the US heart valve device market, resulting in lost procedure volumes in the short term followed by a period of recovery.

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.

In 2019, the TAVR space has seen multiple new FDA approvals that will shape its future.

How will the market react to the approval of TAVR devices in the treatment of low surgical risk patients? How will this compare to when TAVR devices received approval for intermediate- and high-risk patient populations?

How will new TAVR devices entering the market impact market shares and ASPs?

Will these new approvals spur new companies to enter the market?

Coverage decisions made by the CMS will continue to have a significant impact on this market.

Will the new procedural requirements for TAVR influence the TAVR device market as a whole?

Is the CMS expected to announce further coverage changes in the coming years? How will this affect the TMVR patient population and the TMVR device market?

The competitive landscape for the transcatheter mitral valve device market is evolving. 

Will TMVI and TMVR devices compete for market share?

Which companies are poised to earn FDA approval for their TMVI devices first?

Will the future TTVR market be impacted by the launch of TMVR devices?

Large companies with sizable market shares have continued to acquire small companies with original, albeit unapproved, devices.

Which companies are poised to benefit the most from these acquisitions?

Which larger companies exercised options to buy smaller companies they had previously invested in? How will this impact these companies' positions in the market?

The COVID-19 pandemic is having a significant impact on cardiovascular medtech markets.

Which upcoming products and clinical trials will be delayed as a result of the pandemic?

How significantly are heart valve procedure volumes being reduced in the wake of the crisis?

Table of contents

  • Heart Valve Devices - Market Insights - United States
    • Abstract
    • Executive Summary
      • COVID-19 Updates
        • Market Highlights
          • Factors Impacting the Heart Valve Device Market, by Product Type, US
          • Heart Valve Device Market, by Product Type, US (USD), 2019–2029
          • Heart Valve Device Market Landscape, US (USD), 2019 and 2029
        • Competitive Highlights
          • Competitive Factors and Strategies, by Procedure Type, US
          • Heart Valve Device Revenue Market Share Rankings, by Product Type, US, 2019
          • Companies Mentioned
        • Market Developments
          • Recent Events in the Heart Valve Device Market, US
          • Key Clinical Trials in the Heart Valve Devices Market, US
          • Emerging Products for the Heart Valve Device Market, US
          • Companies Developing Transcatheter Devices
        • Procedures Covered
          • Heart Valve Device Procedures Covered, US
        • Products Covered
          • Heart Valve Devices Covered, US
      • Key Report Updates
        • COVID-19 Analysis
          • Market Impact
            • COVID-19 Impact Assessment Summary, Heart Valve Device Market, US
          • Guidance and Recommendations
            • Guidance and Recommendations for Heart Valve Device Procedures
          • Major Market Forecast Changes and Assumptions
            • Heart Valve Device Market, by Product Type, US (USD), 2019–2029 (Excluding COVID-19 Impact)
            • Heart Valve Device Market, by Product Type, US (USD), 2019–2029 (Including COVID-19 Impact)
          • Competitive Impact
            • COVID-19 Competitive Factors and Strategies, Heart Valve Device Market, US
            • COVID-19 Impact by Competitor, Heart Valve Device Market, US
        • Heart Valve Device Market
          • Market Highlights
            • Factors Impacting the Heart Valve Device Market, by Product Type, US
            • Heart Valve Device Market, by Product Type, US (USD), 2019–2029
            • Heart Valve Device Procedures, by Position, US, 2019–2029
          • Market Definitions
            • Market Forecast Data
              • Heart Valve Device Procedures, by Procedure Type, US, 2019–2029
              • Heart Valve Replacement and Repair Device Procedures, by Position, US, 2019–2029
              • Aortic Heart Valve Device Procedures, by Product Type, US, 2019–2029
              • Mitral Heart Valve Device Procedures, by Procedure Type, US, 2019–2029
              • Mitral Heart Valve Device Procedures, by Product Type, US, 2019–2029
              • Pulmonary Heart Valve Device Procedures, by Product Type, US, 2019–2029
              • Tricuspid Heart Valve Device Procedures, by Procedure Type, US, 2019–2029
              • Tricuspid Heart Valve Device Procedures, by Product Type, US, 2019–2029
              • Heart Valve Device Market, by Procedure Type, US (USD), 2019–2029
              • Heart Valve Device Market Growth, by Procedure Type, US, 2020–2029
              • Heart Valve Device Market, by Product Type, US (USD), 2019–2029
              • Heart Valve Device Market Growth, by Product Type, US, 2020–2029
            • Competitive Highlights
              • Market Shares
                • Heart Valve Device Revenue Market Shares, US, 2019
                • Heart Valve Device Revenue Market Shares, by Procedure Type, US, 2019
              • Competitive Factors and Strategies
                • Competitive Factors and Strategies, by Procedure Type, US
              • Market Developments
                • Recent Events in the Heart Valve Device Market, US
                • Key Clinical Trials in the Heart Valve Devices Market, US
                • Emerging Products for the Heart Valve Device Market, US
                • Companies Developing Transcatheter Devices
            • Heart Valve Replacement Device Market
              • Market Highlights
                • Heart Valve Replacement Device Market, by Technique, US (USD), 2019–2029
                • Heart Valve Replacement Device Market, by Product Type, US (USD), 2019–2029
              • Market Definitions
                • Market Forecast Data
                  • Heart Valve Replacement Device Procedures, by Position, US, 2019–2029
                  • Heart Valve Replacement Device Procedures, by Technique, US, 2019–2029
                  • Heart Valve Replacement Device Procedures, by Product Type, US, 2019–2029
                  • Aortic Heart Valve Replacement Device Procedures, by Technique, US, 2019–2029
                  • Aortic Heart Valve Replacement Device Procedures, by Product Type, US, 2019–2029
                  • Mitral Heart Valve Replacement Device Procedures, by Technique, US, 2019–2029
                  • Mitral Heart Valve Replacement Device Procedures, by Product Type, US, 2019–2029
                  • Pulmonary Heart Valve Replacement Device Procedures, by Technique, US, 2019–2029
                  • Pulmonary Heart Valve Replacement Device Procedures, by Product Type, US, 2019–2029
                  • Tricuspid Heart Valve Replacement Device Procedures, by Technique, US, 2019–2029
                  • Tricuspid Heart Valve Replacement Device Procedures, by Product Type, US, 2019–2029
                  • Heart Valve Replacement Device Market, by Product Type, US (USD), 2019–2029
                  • Heart Valve Replacement Device Market Growth, by Product Type, US, 2020–2029
                  • Heart Valve Replacement Device Market, by Technique, US (USD), 2019–2029
                  • Heart Valve Replacement Device Market Growth, by Technique, US, 2020–2029
                  • Surgical Heart Valve Replacement Device Procedures, by Position, US, 2019–2029
                  • Surgical Heart Valve Replacement Device Procedures, by Product Type, US, 2019–2029
                  • Aortic Surgical Heart Valve Replacement Device Procedures, by Product Type, US, 2019–2029
                  • Mitral Surgical Heart Valve Replacement Device Procedures, by Product Type, US, 2019–2029
                  • Pulmonary Surgical Heart Valve Replacement Device Procedures, by Product Type, US, 2019–2029
                  • Tricuspid Surgical Heart Valve Replacement Device Procedures, by Product Type, US, 2019–2029
                  • Surgical Heart Valve Replacement Device Market, by Product Type, US (USD), 2019–2029
                  • Surgical Heart Valve Replacement Device Market Growth, by Product Type, US, 2020–2029
                  • Tissue Heart Valve Procedures, by Position, US, 2019–2029
                  • Tissue Heart Valve Procedures, by Material, US, 2019–2029
                  • Xenograft Tissue Heart Valve Procedures, by Position, US, 2019–2029
                  • Aortic Xenograft Tissue Heart Valve Procedures, by Product Feature, US, 2019–2029
                  • Allograft Tissue Heart Valve Procedures, by Position, US, 2019–2029
                  • Tissue Heart Valve Market, by Material, US (USD), 2019–2029
                  • Tissue Heart Valve Market Growth, by Material, US, 2020–2029
                  • Xenograft Tissue Heart Valve Market, by Product Feature, US (USD), 2019–2029
                  • Xenograft Tissue Heart Valve Market Growth, by Product Feature, US, 2020–2029
                  • Mechanical Heart Valve Replacement Device Procedures, by Position, US, 2019–2029
                  • Aortic Mechanical Heart Valve Procedures, by Product Feature, US, 2019–2029
                  • Mechanical Heart Valve Market, by Product Feature, US (USD), 2019–2029
                  • Mechanical Heart Valve Market Growth, by Product Feature, US, 2020–2029
                  • Aortic Mechanical Heart Valve Market, by Product Feature, US (USD), 2019–2029
                  • Aortic Mechanical Heart Valve Market Growth, by Product Feature, US, 2020–2029
                  • THV Replacement Device Procedures, by Product Type, US, 2019–2029
                  • THV Replacement Device Market, by Product Type, US (USD), 2019–2029
                  • THV Replacement Device Market Growth, by Product Type, US, 2020–2029
                • Competitive Highlights
                  • Market Shares
                    • Heart Valve Replacement Device Revenue Market Shares, US, 2019
                    • Heart Valve Replacement Device Revenue Market Shares, by Product Type, US, 2019
                  • Competitive Factors and Strategies
                    • Competitive Factors and Strategies, by Technique, US
                • Heart Valve Repair Device Market
                  • Market Highlights
                    • Heart Valve Repair Device Market, by Technique, US (USD), 2019–2029
                    • Heart Valve Repair Device Market, by Product Type, US (USD), 2019–2029
                  • Market Definitions
                    • Market Forecast Data
                      • Heart Valve Repair Device Procedures, by Position, US, 2019–2029
                      • Heart Valve Repair Device Procedures, by Technique, US, 2019–2029
                      • Mitral Heart Valve Repair Device Procedures, by Technique, US, 2019–2029
                      • Tricuspid Heart Valve Repair Device Procedures, by Technique, US, 2019–2029
                      • Heart Valve Repair Device Market, by Technique, US (USD), 2019–2029
                      • Heart Valve Repair Device Market Growth, by Technique, US, 2020–2029
                      • Surgical Annuloplasty Device Procedures, by Position, US, 2019–2029
                      • Surgical Annuloplasty Device Procedures, by Shape, US, 2019–2029
                      • Surgical Annuloplasty Device Market, by Shape, US (USD), 2019–2029
                      • Surgical Annuloplasty Device Market Growth, by Shape, US, 2020–2029
                      • THV Repair Device Procedures, by Product Type, US, 2019–2029
                      • THV Repair Device Market, by Product Type, US (USD), 2019–2029
                      • THV Repair Device Market Growth, by Product Type, US, 2020–2029
                    • Competitive Highlights
                      • Market Shares
                        • Heart Valve Repair Device Revenue Market Shares, US, 2019
                        • Heart Valve Repair Device Revenue Market Shares, by Technique, US, 2019
                      • Competitive Factors and Strategies
                        • Competitive Factors and Strategies, by Technique, US
                    • Heart Valve Accessory Device Market
                      • Market Highlights
                        • Heart Valve Accessory Device Market, by Product Type, US (USD), 2019–2029
                      • Market Definitions
                        • Market Forecast Data
                          • Heart Valve Accessory Device Procedures, by Product Type, US, 2019–2029
                          • Valvuloplasty Balloon Procedures, by Position, US, 2019–2029
                          • Heart Valve Accessory Device Market, by Product Type, US (USD), 2019–2029
                          • Heart Valve Accessory Device Market Growth, by Product Type, US, 2020–2029
                        • Competitive Highlights
                          • Market Shares
                            • Heart Valve Accessories Device Revenue Market Shares, US, 2019
                            • Heart Valve Accessories Device Revenue Market Shares, by Product Type, US, 2019
                          • Competitive Factors and Strategies
                            • Competitive Factors and Strategies, by Technique, US
                        • Appendix
                          • Abbreviations
                            • Bibliography

                          Author(s): Drew Wallace

                          Drew C. Wallace is an analyst on the Cardiovascular Medtech Insights team, specializing in heart valve and cardiac rhythm management device markets. Drew holds a Master's degree in Developmental Biology from the University of Western Ontario. Prior to his current position, Drew worked at the Princess Margaret Cancer Centre on the immunotherapy clinical trial program. 


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