United States (US) Structural Heart Devices Market (2025-2031) Outlook | Forecast, Size, Analysis, Trends, Companies, Value, Share, Growth, Revenue & Industry

Market Forecast By Product (Herat Valve Devices, Surgical Heart Valves, Transcatheter Heart Valves, Occluders and Delivery Systems, Annuloplasty Rings, Other Devices, Accessories), By Procedure (Replacement Procedures, TAVR Procedures, SAVR Procedures, Repair Procedures, Closure Procedures, Annuloplasty, Valvuloplasty, TMVR Procedures) And Competitive Landscape
Product Code: ETC348241 Publication Date: Aug 2022 Updated Date: Jun 2025 Product Type: Market Research Report
Publisher: 6Wresearch Author: Sachin Kumar Rai No. of Pages: 75 No. of Figures: 35 No. of Tables: 20

United States (US) Structural Heart Devices Market Overview

The United States Structural Heart Devices Market is a rapidly growing sector within the medical device industry, focused on treating structural abnormalities of the heart through minimally invasive procedures. Key products in this market include transcatheter aortic valve replacement (TAVR) devices, transcatheter mitral valve repair (TMVR) devices, and left atrial appendage closure devices. Factors driving market growth include the increasing prevalence of heart diseases, aging population, technological advancements in device design, and rising demand for less invasive treatment options. Major players in the US Structural Heart Devices Market are Edwards Lifesciences, Medtronic, Abbott Laboratories, Boston Scientific, and LivaNova. As healthcare providers and patients continue to seek innovative solutions for heart conditions, the market is expected to expand further in the coming years.

United States (US) Structural Heart Devices Market Trends

The US Structural Heart Devices Market is witnessing several key trends. One trend is the increasing adoption of minimally invasive procedures for treating structural heart conditions, such as transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair/replacement. These procedures offer shorter recovery times and reduced complications compared to traditional open-heart surgeries. Another trend is the rising prevalence of structural heart diseases, driven by an aging population and lifestyle factors, leading to a growing demand for innovative devices and technologies. Additionally, advancements in imaging techniques and materials are enhancing the precision and effectiveness of structural heart interventions. Market players are also focusing on developing next-generation devices with improved outcomes and patient safety. Overall, the US Structural Heart Devices Market is poised for significant growth and innovation in the coming years.

United States (US) Structural Heart Devices Market Challenges

In the US Structural Heart Devices Market, challenges include stringent regulatory requirements for product approvals, increasing competition among market players, and the high cost associated with these advanced medical devices. Regulatory hurdles often lead to delays in product launches and market penetration, impacting companies` revenue streams. Additionally, the market is witnessing a surge in the number of new entrants and innovative technologies, intensifying competition and putting pressure on established companies to differentiate their offerings. The high cost of structural heart devices poses a barrier to adoption, particularly for patients without adequate insurance coverage or in regions with limited healthcare resources. Overcoming these challenges requires companies to invest in research and development, navigate complex regulatory pathways, and explore cost-effective strategies to ensure market growth and sustainability.

United States (US) Structural Heart Devices Market Investment Opportunities

The US Structural Heart Devices Market presents lucrative investment opportunities due to factors such as a growing aging population, increasing prevalence of cardiovascular diseases, and technological advancements in minimally invasive procedures. Key areas for investment include transcatheter aortic valve replacement (TAVR), transcatheter mitral valve repair, and left atrial appendage closure devices. TAVR, in particular, has witnessed significant growth and adoption, with potential for further expansion as it offers a less invasive alternative to traditional open-heart surgery for aortic valve replacement. Companies involved in developing innovative devices, expanding market presence, and strategic collaborations in this market segment are likely to attract investor interest and drive growth in the US structural heart devices market.

United States (US) Structural Heart Devices Market Government Policy

The US government regulates the Structural Heart Devices Market through the Food and Drug Administration (FDA), which oversees the approval of these medical devices to ensure safety and efficacy. Market approval requires companies to conduct rigorous clinical trials to demonstrate product effectiveness and safety before entering the market. The FDA also monitors post-market surveillance to track device performance and any potential adverse events. Reimbursement policies under government programs such as Medicare play a crucial role in market access for these devices, with coverage decisions impacting adoption rates. Additionally, ongoing healthcare policy changes and initiatives, such as value-based care and healthcare affordability efforts, can influence market dynamics and opportunities for structural heart device manufacturers in the US.

United States (US) Structural Heart Devices Market Future Outlook

The United States Structural Heart Devices Market is expected to witness significant growth in the coming years due to factors such as the increasing prevalence of structural heart diseases, advancements in minimally invasive procedures, and a growing aging population. Additionally, the rising demand for innovative treatment options, such as transcatheter aortic valve replacement (TAVR) and left atrial appendage closure devices, is driving market expansion. Technological developments and ongoing research in the field are likely to further propel market growth. However, challenges like stringent regulatory requirements and the high cost associated with these devices may hinder market growth to some extent. Overall, the US Structural Heart Devices Market is poised for steady growth and offers opportunities for manufacturers to introduce novel products and expand their market presence.

Key Highlights of the Report:

  • United States (US) Structural Heart Devices Market Outlook
  • Market Size of United States (US) Structural Heart Devices Market, 2024
  • Forecast of United States (US) Structural Heart Devices Market, 2031
  • Historical Data and Forecast of United States (US) Structural Heart Devices Revenues & Volume for the Period 2021 - 2031
  • United States (US) Structural Heart Devices Market Trend Evolution
  • United States (US) Structural Heart Devices Market Drivers and Challenges
  • United States (US) Structural Heart Devices Price Trends
  • United States (US) Structural Heart Devices Porter's Five Forces
  • United States (US) Structural Heart Devices Industry Life Cycle
  • Historical Data and Forecast of United States (US) Structural Heart Devices Market Revenues & Volume By Product for the Period 2021 - 2031
  • Historical Data and Forecast of United States (US) Structural Heart Devices Market Revenues & Volume By Herat Valve Devices for the Period 2021 - 2031
  • Historical Data and Forecast of United States (US) Structural Heart Devices Market Revenues & Volume By Surgical Heart Valves for the Period 2021 - 2031
  • Historical Data and Forecast of United States (US) Structural Heart Devices Market Revenues & Volume By Transcatheter Heart Valves for the Period 2021 - 2031
  • Historical Data and Forecast of United States (US) Structural Heart Devices Market Revenues & Volume By Occluders and Delivery Systems for the Period 2021 - 2031
  • Historical Data and Forecast of United States (US) Structural Heart Devices Market Revenues & Volume By Annuloplasty Rings for the Period 2021 - 2031
  • Historical Data and Forecast of United States (US) Structural Heart Devices Market Revenues & Volume By Other Devices for the Period 2021 - 2031
  • Historical Data and Forecast of United States (US) Structural Heart Devices Market Revenues & Volume By Accessories for the Period 2021 - 2031
  • Historical Data and Forecast of United States (US) Structural Heart Devices Market Revenues & Volume By Procedure for the Period 2021 - 2031
  • Historical Data and Forecast of United States (US) Structural Heart Devices Market Revenues & Volume By Replacement Procedures for the Period 2021 - 2031
  • Historical Data and Forecast of United States (US) Structural Heart Devices Market Revenues & Volume By TAVR Procedures for the Period 2021 - 2031
  • Historical Data and Forecast of United States (US) Structural Heart Devices Market Revenues & Volume By SAVR Procedures for the Period 2021 - 2031
  • Historical Data and Forecast of United States (US) Structural Heart Devices Market Revenues & Volume By Repair Procedures for the Period 2021 - 2031
  • Historical Data and Forecast of United States (US) Structural Heart Devices Market Revenues & Volume By Closure Procedures for the Period 2021 - 2031
  • Historical Data and Forecast of United States (US) Structural Heart Devices Market Revenues & Volume By Annuloplasty for the Period 2021 - 2031
  • Historical Data and Forecast of United States (US) Structural Heart Devices Market Revenues & Volume By Valvuloplasty for the Period 2021 - 2031
  • Historical Data and Forecast of United States (US) Structural Heart Devices Market Revenues & Volume By TMVR Procedures for the Period 2021 - 2031
  • United States (US) Structural Heart Devices Import Export Trade Statistics
  • Market Opportunity Assessment By Product
  • Market Opportunity Assessment By Procedure
  • United States (US) Structural Heart Devices Top Companies Market Share
  • United States (US) Structural Heart Devices Competitive Benchmarking By Technical and Operational Parameters
  • United States (US) Structural Heart Devices Company Profiles
  • United States (US) Structural Heart Devices Key Strategic Recommendations

Frequently Asked Questions About the Market Study (FAQs):

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1 Executive Summary

2 Introduction

2.1 Key Highlights of the Report

2.2 Report Description

2.3 Market Scope & Segmentation

2.4 Research Methodology

2.5 Assumptions

3 United States (US) Structural Heart Devices Market Overview

3.1 United States (US) Country Macro Economic Indicators

3.2 United States (US) Structural Heart Devices Market Revenues & Volume, 2021 & 2031F

3.3 United States (US) Structural Heart Devices Market - Industry Life Cycle

3.4 United States (US) Structural Heart Devices Market - Porter's Five Forces

3.5 United States (US) Structural Heart Devices Market Revenues & Volume Share, By Product, 2021 & 2031F

3.6 United States (US) Structural Heart Devices Market Revenues & Volume Share, By Procedure, 2021 & 2031F

4 United States (US) Structural Heart Devices Market Dynamics

4.1 Impact Analysis

4.2 Market Drivers

4.3 Market Restraints

5 United States (US) Structural Heart Devices Market Trends

6 United States (US) Structural Heart Devices Market, By Types

6.1 United States (US) Structural Heart Devices Market, By Product

6.1.1 Overview and Analysis

6.1.2 United States (US) Structural Heart Devices Market Revenues & Volume, By Product, 2021 - 2031F

6.1.3 United States (US) Structural Heart Devices Market Revenues & Volume, By Herat Valve Devices, 2021 - 2031F

6.1.4 United States (US) Structural Heart Devices Market Revenues & Volume, By Surgical Heart Valves, 2021 - 2031F

6.1.5 United States (US) Structural Heart Devices Market Revenues & Volume, By Transcatheter Heart Valves, 2021 - 2031F

6.1.6 United States (US) Structural Heart Devices Market Revenues & Volume, By Occluders and Delivery Systems, 2021 - 2031F

6.1.7 United States (US) Structural Heart Devices Market Revenues & Volume, By Annuloplasty Rings, 2021 - 2031F

6.1.8 United States (US) Structural Heart Devices Market Revenues & Volume, By Other Devices, 2021 - 2031F

6.2 United States (US) Structural Heart Devices Market, By Procedure

6.2.1 Overview and Analysis

6.2.2 United States (US) Structural Heart Devices Market Revenues & Volume, By Replacement Procedures, 2021 - 2031F

6.2.3 United States (US) Structural Heart Devices Market Revenues & Volume, By TAVR Procedures, 2021 - 2031F

6.2.4 United States (US) Structural Heart Devices Market Revenues & Volume, By SAVR Procedures, 2021 - 2031F

6.2.5 United States (US) Structural Heart Devices Market Revenues & Volume, By Repair Procedures, 2021 - 2031F

6.2.6 United States (US) Structural Heart Devices Market Revenues & Volume, By Closure Procedures, 2021 - 2031F

6.2.7 United States (US) Structural Heart Devices Market Revenues & Volume, By Annuloplasty, 2021 - 2031F

6.2.8 United States (US) Structural Heart Devices Market Revenues & Volume, By TMVR Procedures, 2021 - 2031F

6.2.9 United States (US) Structural Heart Devices Market Revenues & Volume, By TMVR Procedures, 2021 - 2031F

7 United States (US) Structural Heart Devices Market Import-Export Trade Statistics

7.1 United States (US) Structural Heart Devices Market Export to Major Countries

7.2 United States (US) Structural Heart Devices Market Imports from Major Countries

8 United States (US) Structural Heart Devices Market Key Performance Indicators

9 United States (US) Structural Heart Devices Market - Opportunity Assessment

9.1 United States (US) Structural Heart Devices Market Opportunity Assessment, By Product, 2021 & 2031F

9.2 United States (US) Structural Heart Devices Market Opportunity Assessment, By Procedure, 2021 & 2031F

10 United States (US) Structural Heart Devices Market - Competitive Landscape

10.1 United States (US) Structural Heart Devices Market Revenue Share, By Companies, 2024

10.2 United States (US) Structural Heart Devices Market Competitive Benchmarking, By Operating and Technical Parameters

11 Company Profiles

12 Recommendations

13 Disclaimer

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