North America Heart Valve Devices Market Report and Forecast 2025-2034

The North America heart valve devices market was valued at USD 5.99 Billion in 2024, 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 2025-2034, with the values likely to reach USD 15.68 Billion by 2034.

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

The market is witnessing several trends and developments to improve the current scenario. Some of the notable trends are as follows:

Robust Regulatory Support

In September 2024, Pi-Cardia Ltd, a global innovator in leaflet modification solutions for heart valve treatment, announced that the U.S. Food and Drug Administration (FDA) granted market clearance for ShortCut™, the first device specifically designed for leaflet modification during valve-in-valve transcatheter aortic valve replacement (TAVR) procedures in patients at risk of coronary obstruction. The increasing number of regulatory approvals for novel heart valve devices is expected to boost the North America heart valve devices market demand.

Expansion of Transcatheter Interventions Beyond the Aortic Valve

In January 2025, the MUSC Health team in South Carolina performed the first United States implantation of the Topaz transcatheter tricuspid valve replacement (TTVR) system, developed by TriCares. This marks a major development in the North America heart valve devices market, highlighting the growing shift toward transcatheter therapies for valve conditions beyond the aortic position.

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.

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 2024?
• What is the North America heart valve devices market forecast outlook for 2025-2034?
• 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?

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