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Report Overview

The North America heart valve devices market was valued at USD 6.59 Billion in 2025, driven by the advancements in transcatheter technologies and favorable regulatory environment in the region. The market is anticipated to grow at a CAGR of 10.10% during the forecast period of 2026-2035, with the values likely to reach USD 17.25 Billion by 2035.

2025

Base Year

2019-2025

Historical Period

2026-2035

Forecast Period

  • The expanding aging population is leading to a growing incidence of aortic stenosis and degenerative valve disease, which is poised to augment market demand in the forecast period.

  • The shift towards advanced heart valve technologies designed for minimally invasive, high-precision interventions, especially those that address risks like coronary obstruction, is anticipated to elevate the North America heart valve devices market value.

  • Accelerated FDA approvals, such as Pi-Cardia’s ShortCut™ and next-gen self-expanding valves, are a significant market trend.

Compound Annual Growth Rate

10.1%

Value in USD Billion

2026-2035


*this image is indicative*

North America Heart Valve Devices Market Overview

In North America, the rising demand for minimally invasive cardiac procedures and a steady influx of technological innovations are the key drivers of the heart valve devices market. The region benefits from a robust healthcare infrastructure, high awareness among cardiologists and patients, and supportive reimbursement systems, which encourage early adoption of advanced valve technologies. Additionally, the high incidence of valvular heart disease and expanding clinical applications of transcatheter devices are projected to support market growth in the forecast period.

North America Heart Valve Devices Market Growth Drivers

Rising Prevalence of Valvular Heart Diseases to Drive Market Growth

The U.S. Centers for Disease Control and Prevention (CDC) reports that over 5 million individuals in the United States are diagnosed with heart valve disease annually. The condition also contributes to more than 25,000 deaths each year. The rising disease burden is influencing the demand for heart valve repair and replacement devices, which is poised to bolster the market growth in North America in the coming years.

North America Heart Valve Devices Market Trends

North America Heart Valve Devices Market Segmentation

The market report offers a detailed analysis of the market based on the following segments:

Market Breakup by Valve Type

  • Biological (Tissue) Valve
  • Mechanical Valve

Market Breakup by Product Type

  • Replacement Devices
    • Mechanical Valve
    • Bioprosthetic Valve
    • Transcatheter Aortic Valve Replacement (TAVR)
  • Repair Devices
    • Surgical Valve
    • Transcatheter Mitral Valve Replacement (TMVR)
    • Balloon Valvuloplasty Devices

Market Breakup by Procedure

  • Open Surgery
  • Minimally Invasive Surgery (MIS)

Market Breakup by End User

  • Hospitals
  • Ambulatory Surgical Centers (ASCs)
  • Others

Market Breakup by Region

  • United States of America
  • Canada

North America Heart Valve Devices Market Share

Segmentation Based on Valve Type to Witness Substantial Growth

Based on valve type, the market is segmented into biological (tissue) valves and mechanical valves. In North America, biological valves hold a significant market share due to their growing preference among elderly patients and those seeking valve replacements without long-term anticoagulation therapy. Mechanical valves are typically recommended for younger patients due to their longevity, but require lifelong blood-thinning medication, which limits their usage.

North America Heart Valve Devices Market Analysis by Region

Based on the region, the market is segmented into the United States of America and Canada. The United States of America dominates the North American market for heart valve devices due to early technology adoption, a large patient base, and a robust healthcare infrastructure. The increasing number of FDA approvals also helps in accelerating the integration of next-generation heart valve devices. Moreover, the presence of key players like Medtronic, Edwards Lifesciences, and Abbott supports market growth in the region.

Leading Players in the North America Heart Valve Devices Market

The key features of the market report comprise patent analysis, grants analysis, funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:

Medtronic plc

Medtronic holds a prominent position in the North America heart valve devices market. Its product portfolio includes the widely adopted Evolut™ R and Evolut™ PRO systems, which are routinely used for managing aortic stenosis. In addition to TAVR, Medtronic offers an extensive range of surgical valve replacement and repair solutions.

Edwards Lifesciences Corporation

Edwards Lifesciences, based in Irvine, California, is known for its advanced heart valve technologies. Its SAPIEN™ valve series has helped improve aortic valve replacement procedures. The company also offers a variety of surgical heart valves and hemodynamic monitoring systems.

Abbott

Headquartered in Illinois, Abbott significantly contributes to the North America heart valve devices market growth. Its portfolio includes the MitraClip™ system for minimally invasive mitral valve repair, the TriClip™ for tricuspid valve interventions, and the Portico™ TAVR system for aortic valve replacement.

Corcym Group

Corcym Group, an Italy-based medical device company focused on structural heart treatment, has established a strong presence in the North American market through distribution partnerships. Its offerings include mechanical and tissue heart valves, such as the Carbomedics™ and Bicarbon™ lines, which are used in a variety of surgical applications.

*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*

Other key players in the market include Boston Scientific Corporation, Artivion, Inc., Micro Interventional Devices, Incorporated, Shockwave Medical Inc. (Johnson & Johnson Services, Inc.), and JenaValve Technology, Inc.

Key Questions Answered in the North America Heart Valve Devices Market Report

  • What was the North America heart valve devices market value in 2025?
  • What is the North America heart valve devices market forecast outlook for 2026-2035?
  • What is the market segmentation based on valve type?
  • What is the market segmentation based on product type?
  • What is the market breakup based on the procedure?
  • What is the market breakup by end user?
  • What major factors aid the North America heart valve devices market demand?
  • Which regional market is expected to dominate the market share in the forecast period?
  • Which country is likely to experience elevated growth during the forecast period?
  • How has the market performed so far and how is it anticipated to perform in the coming years?
  • What are the major drivers, opportunities, and restraints in the market?
  • What are the major trends influencing the market?
  • Who are the key players involved in the North America heart valve devices market?
  • What are the current unmet needs and challenges in the market?
  • How are partnerships, collaborations, mergers, and acquisitions among the key market players shaping the market dynamics?

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Report Summary

Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.

Key Highlights of the Report

Please note that the figures mentioned in the description serve as estimates and may vary from the actual figures presented in the final report.

REPORT FEATURES DETAILS
Base Year 2025
Historical Period 2019-2025
Forecast Period 2026-2035
Scope of the Report

Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:

  • Valve Type
  • Product Type
  • Procedure
  • End User
  • Country
Breakup by Valve Type
  • Biological (Tissue) Valve
  • Mechanical Valve
Breakup by Product Type
  • Replacement Devices
  • Repair Devices
Breakup by Procedure
  • Open Surgery
  • Minimally Invasive Surgery (MIS)
Breakup by End User
  • Hospitals
  • Ambulatory Surgical Centers (ASCs)
  • Others
Breakup by Region
  • United States of America
  • Canada
Market Dynamics
  • Market Drivers and Constraints
  • SWOT Analysis
  • PESTEL Analysis
  • Porter’s Five Forces Model 
  • Key Demand Indicators
  • Key Price Indicators
  • Industry Events, Initiatives, and Trends 
  • Value Chain Analysis
Supplier Landscape
  • Market Structure
  • Company Profiles
    • Financial Analysis
    • Product Portfolio
    • Demographic Reach and Achievements
    • Company News and Developments
    • Certifications
Companies Covered
  • Medtronic plc
  • Edwards Lifesciences Corporation
  • Abbott
  • Corcym Group
  • Boston Scientific Corporation
  • Artivion, Inc
  • Micro Interventional Devices, Incorporated
  • Shockwave Medical Inc. (Johnson & Johnson, Services Inc.)
  • JenaValve Technology, Inc.

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