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.

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?

Table of contents

  • United States
    • Abstract
    • Executive Summary
      • Market Highlights
      • Competitive Highlights
      • Market Developments
      • Procedures Covered
      • Products Covered
    • Key Report Updates
    • Heart Valve Device Market
      • Market Highlights
      • Market Definitions
      • Market Forecast Data
      • Competitive Highlights
      • Market Shares
      • Competitive Factors and Strategies
        • Clinical Data
        • Emerging Technologies
        • Market Appeal
        • Physician Training and Marketing
        • Product Improvements and Innovations
        • Mergers, Acquisitions, and Partnerships
        • Product Portfolio Management
        • Intellectual Property
      • Market Developments
    • Heart Valve Replacement Device Market
      • Market Highlights
      • Market Definitions
      • Market Forecast Data
        • Surgical Heart Valve Replacement Devices
        • Transcatheter Heart Valve Replacement Devices
      • Competitive Highlights
      • Market Shares
      • Competitive Factors and Strategies
        • Clinical Data
        • Emerging Technologies
        • Product Improvements and Innovations
        • Intellectual Property
    • Heart Valve Repair Device Market
      • Market Highlights
      • Market Definitions
      • Market Forecast Data
        • Surgical Annuloplasty Devices
        • Transcatheter Heart Valve Repair Devices
      • Competitive Highlights
      • Market Shares
      • Competitive Factors and Strategies
        • Clinical Data
        • Emerging Technologies
        • Market Appeal
        • Mergers, Acquisitions, and Partnerships
    • Heart Valve Accessory Device Market
      • Market Highlights
      • Market Definitions
      • Market Forecast Data
      • Competitive Highlights
      • Market Shares
      • Competitive Factors and Strategies
    • Appendix
      • Abbreviations
      • Bibliography

Author(s): Drew Wallace

Drew C. Wallace is an analyst on the Cardiovascular Medtech Insights team, specializing in heart valve device markets. Drew holds a Master's degree in Developmental Biology from the University of Western Ontario.


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