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

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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