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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.
Base Year
Historical Period
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*
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.
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.
The market is witnessing several trends and developments to improve the current scenario. Some of the notable trends are as follows:
The market report offers a detailed analysis of the market based on the following segments:
Market Breakup by Valve Type
Market Breakup by Product Type
Market Breakup by Procedure
Market Breakup by End User
Market Breakup by Region
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.
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.
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 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, 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.
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, 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.
*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 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:
|
| Breakup by Valve Type |
|
| Breakup by Product Type |
|
| Breakup by Procedure |
|
| Breakup by End User |
|
| Breakup by Region |
|
| Market Dynamics |
|
| Supplier Landscape |
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| Companies Covered |
|
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