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    US Structural Heart Devices Market

    ID: MRFR/MED/14087-HCR
    100 Pages
    Rahul Gotadki
    October 2025

    US Structural Heart Devices Market Research Report By Type (Heart Valve Devices, Annuloplasty Rings, Occluders, Delivery Systems), By Indication (Valvular Heart Disease, Cardiomyopathy) and By Procedure (Replacement Procedures, Repair Procedures) - Forecast to 2035

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    US Structural Heart Devices Market Infographic
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    US Structural Heart Devices Market Summary

    As per MRFR analysis, the US structural heart-devices market size was estimated at 175.18 USD Million in 2024. The US structural heart-devices market is projected to grow from 186.77 USD Million in 2025 to 354.57 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 6.62% during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    The US structural heart-devices market is poised for substantial growth driven by technological advancements and demographic shifts.

    • Technological advancements in device design are enhancing the efficacy and safety of structural heart devices.
    • Aging population in the US is contributing to an increased demand for heart-related interventions.
    • The transcatheter heart valve segment is currently the largest, while the left atrial appendage closure segment is the fastest-growing.
    • Rising prevalence of cardiovascular diseases and supportive reimbursement policies are key drivers propelling market expansion.

    Market Size & Forecast

    2024 Market Size 175.18 (USD Million)
    2035 Market Size 354.57 (USD Million)

    Major Players

    Edwards Lifesciences (US), Medtronic (US), Abbott Laboratories (US), Boston Scientific (US), Cardinal Health (US), LivaNova (GB), Terumo Corporation (JP), JenaValve Technology (DE), AtriCure (US)

    US Structural Heart Devices Market Trends

    The structural heart-devices market is currently experiencing notable advancements. These advancements are driven by technological innovations and an increasing prevalence of heart-related conditions. The integration of minimally invasive techniques is reshaping treatment protocols, allowing for reduced recovery times and improved patient outcomes. Furthermore, the aging population in the US is contributing to a higher demand for these devices, as older individuals are more susceptible to structural heart diseases. This demographic shift is prompting manufacturers to focus on developing devices that cater specifically to the needs of this population, thereby enhancing market growth. In addition, regulatory bodies are playing a crucial role in shaping the landscape of the structural heart-devices market. Streamlined approval processes for new devices are encouraging innovation and expediting the introduction of advanced solutions. As a result, healthcare providers are increasingly adopting these technologies, which may lead to improved patient care and satisfaction. The combination of demographic trends, technological advancements, and supportive regulatory frameworks suggests a promising future for the structural heart-devices market, with potential for continued expansion and innovation in the coming years.

    Technological Advancements

    Innovations in device design and materials are enhancing the efficacy and safety of treatments. New technologies, such as transcatheter techniques, are gaining traction, allowing for less invasive procedures that reduce recovery times and improve patient outcomes.

    Aging Population

    The increasing number of elderly individuals in the US is driving demand for structural heart devices. As age is a significant risk factor for heart diseases, this demographic shift necessitates the development of tailored solutions to address their specific health needs.

    Regulatory Support

    Regulatory agencies are facilitating faster approvals for new devices, which encourages innovation within the market. This supportive environment is likely to lead to the introduction of advanced technologies that improve patient care and treatment options.

    US Structural Heart Devices Market Drivers

    Supportive Reimbursement Policies

    Supportive reimbursement policies in the US are playing a pivotal role in the growth of the structural heart-devices market. Insurance providers are increasingly recognizing the value of advanced structural heart devices and are offering favorable reimbursement rates for these procedures. This trend is encouraging healthcare providers to adopt innovative technologies, as the financial burden on patients is reduced. Additionally, government programs and initiatives aimed at improving access to cardiac care are further bolstering the market. As reimbursement policies evolve to support the use of advanced devices, the structural heart-devices market is expected to expand, providing patients with greater access to life-saving treatments and improving overall health outcomes.

    Technological Innovations in Device Design

    Technological innovations in the design and functionality of structural heart devices are transforming the market landscape. Advances in materials science, imaging technologies, and minimally invasive techniques are enabling the development of more effective and safer devices. For instance, the introduction of bioresorbable stents and transcatheter heart valves has revolutionized treatment options for patients with structural heart conditions. These innovations not only enhance patient outcomes but also reduce recovery times and hospital stays, making them attractive options for both patients and healthcare providers. As manufacturers continue to invest in research and development, the structural heart-devices market is likely to witness a surge in new product launches and improved device performance, further driving market growth.

    Rising Prevalence of Cardiovascular Diseases

    The increasing incidence of cardiovascular diseases in the US is a primary driver for the structural heart-devices market. According to the American Heart Association, cardiovascular diseases account for approximately 1 in every 4 deaths in the US. This alarming statistic highlights the urgent need for effective treatment options, including structural heart devices. As the population ages and lifestyle-related health issues become more prevalent, the demand for innovative solutions to manage these conditions is expected to rise. The structural heart-devices market is likely to benefit from this trend, as healthcare providers seek advanced technologies to improve patient outcomes and reduce healthcare costs. Furthermore, The market is projected to grow at a CAGR of around 8% from 2025 to 2035.

    Growing Awareness and Education on Heart Health

    The rising awareness and education regarding heart health among the US population is a crucial driver for the structural heart-devices market. Public health campaigns and initiatives aimed at educating individuals about cardiovascular diseases and their risk factors have led to increased screening and early diagnosis. As more people become aware of their heart health, there is a greater likelihood of seeking medical intervention, which includes the use of structural heart devices. This heightened awareness is expected to contribute to the growth of the market, as patients are more inclined to explore treatment options. Furthermore, healthcare providers are increasingly emphasizing the importance of preventive care, which may lead to earlier interventions and a higher demand for innovative devices in the structural heart-devices market.

    Increased Investment in Healthcare Infrastructure

    Investment in healthcare infrastructure in the US is significantly impacting the structural heart-devices market. With the ongoing expansion of hospitals and specialized cardiac care centers, there is a growing demand for advanced medical technologies. The US government and private sector are allocating substantial funds to enhance healthcare facilities, which includes the procurement of state-of-the-art structural heart devices. This trend is expected to create a favorable environment for manufacturers and suppliers in the structural heart-devices market. As healthcare facilities upgrade their equipment and technology, the adoption of innovative devices is likely to increase, thereby driving market growth. Additionally, the focus on improving patient care and outcomes is pushing healthcare providers to invest in advanced solutions, further propelling the demand for structural heart devices.

    Market Segment Insights

    By Type: Transcatheter Aortic Valve Replacement (Largest) vs. Mitral Valve Repair Devices (Fastest-Growing)

    The US structural heart-devices market exhibits distinct segmentation, with Transcatheter Aortic Valve Replacement (TAVR) holding the largest share among the available device types. This segment has gained significant traction due to its minimally invasive nature and favorable outcomes compared to traditional surgical options. In contrast, Mitral Valve Repair Devices are swiftly gaining market share as healthcare providers increasingly adopt innovative solutions for mitral valve conditions, driven by growing awareness and successful clinical outcomes. Growth trends indicate a robust increase in demand for both TAVR and Mitral Valve Repair Devices. Factors contributing to this growth include rising incidences of heart diseases, advancements in medical technology, and an aging population more prone to structural heart issues. Furthermore, as healthcare systems prioritize less invasive procedures, the market for Left Atrial Appendage Closure Devices and Transcatheter Pulmonary Valve is also expanding, although at a slower rate compared to TAVR and Mitral Valve Repair Devices.

    Transcatheter Aortic Valve Replacement (Dominant) vs. Mitral Valve Repair Devices (Emerging)

    Transcatheter Aortic Valve Replacement (TAVR) is the dominant player in the structural heart-devices segment, primarily due to its established safety profile and effectiveness in patients with severe aortic stenosis. The procedure's minimally invasive approach significantly reduces recovery time, making it preferable for older patients who may not tolerate traditional surgery well. On the other hand, Mitral Valve Repair Devices, although emerging, are capturing attention with innovative technologies that offer effective solutions for mitral regurgitation. These devices are gaining traction due to their efficacy and the rising demand for less invasive surgical alternatives. As research and development efforts continue, we can expect further advancements in this class of devices, leading to enhanced clinical outcomes and increasing adoption rates.

    By Procedure Type: Minimally Invasive (Largest) vs. Surgical (Fastest-Growing)

    In the US structural heart-devices market, the procedure type segment reveals that minimally invasive techniques dominate the landscape due to their advantages in reducing recovery time and hospital stays. Surgical procedures, while traditionally significant, have seen a gradual shift as advancements in technology enhance the efficacy of less invasive options, capturing a notable share of the market. Growth trends indicate a strong inclination toward percutaneous and minimally invasive methods, driven by increasing patient awareness and preference for less traumatic solutions. The surgical segment, however, is witnessing a resurgence as innovative techniques and technologies emerge, making it the fastest-growing option. This evolution underscores the dynamic nature of the market and the continuous need for adaptation by manufacturers.

    Minimally Invasive (Dominant) vs. Surgical (Emerging)

    Minimally invasive procedures are characterized by their ability to significantly reduce risk, pain, and recovery time, positioning them as the dominant force in the market. The appeal lies in their precision and efficiency, catering to a growing segment of health-conscious patients seeking effective treatments with minimal impact. On the other hand, surgical techniques, once the gold standard, are now emerging with new technology that bridges the gap created by minimally invasive alternatives. These advances are enabling surgical procedures to regain traction, catering to complex cases where minimally invasive approaches may not suffice. As such, the market reflects a diverse range of preferences, with both methodologies playing crucial roles in patient care.

    By Indication: Aortic Stenosis (Largest) vs. Mitral Regurgitation (Fastest-Growing)

    In the US structural heart-devices market, Aortic Stenosis holds the largest share among the indication segments, driven by an increasing patient population and a high prevalence of the condition. Mitral Regurgitation is emerging as a rapidly growing segment, with advancements in treatment options contributing to its market growth. Heart Failure and Pulmonary Valve Stenosis, while important, currently represent smaller shares in comparison to these dominant segments. The growth of the Mitral Regurgitation segment is attributed to the rise in minimally invasive procedures and improved device technology, which enhances patient outcomes. Factors such as an aging population and increasing awareness about heart diseases are stimulating demand across the segments. As healthcare providers embrace innovative treatments, both Aortic Stenosis and Mitral Regurgitation segments are expected to see sustained growth in the near future.

    Aortic Stenosis (Dominant) vs. Mitral Regurgitation (Emerging)

    Aortic Stenosis is characterized by the narrowing of the aortic valve, leading to significant cardiac complications. This segment benefits from established treatment protocols and a strong market presence, making it the dominant force within the indications. Conversely, Mitral Regurgitation is gaining traction, driven by innovative therapies and a growing recognition of the condition's impact on heart health. This segment is increasingly seen as an emerging opportunity, particularly with the introduction of cutting-edge devices and techniques, which are proving effective in addressing the condition. As both segments evolve, they will likely shape the future landscape of the US structural heart-devices market.

    By End User: Hospitals (Largest) vs. Ambulatory Surgical Centers (Fastest-Growing)

    In the US structural heart-devices market, hospitals command a significant share, reflecting their pivotal role in providing advanced cardiovascular care. They are equipped with the latest technologies and specialized staff, making them a primary destination for complex procedures. In contrast, ambulatory surgical centers are rapidly increasing their market presence, capitalizing on the demand for cost-effective and efficient outpatient care. This trend is driven by the growing preference for less invasive procedures that can be completed in a single visit without the need for prolonged hospital stays. Growth trends reveal that while hospitals remain the dominant end-user segment, ambulatory surgical centers are poised for substantial growth. Factors contributing to this shift include changes in reimbursement models favoring outpatient procedures, technological advancements that enable safe and efficient surgeries outside traditional hospital settings, and patients' increasing desire for convenience. Additionally, cardiology clinics are also witnessing steady demand, providing a tailored approach to heart care for specific patient needs.

    Hospitals (Dominant) vs. Ambulatory Surgical Centers (Emerging)

    Hospitals play a dominant role in the US structural heart-devices market, characterized by their comprehensive facilities and ability to handle complex cases that require extensive surgical intervention and critical care. Their robust infrastructure supports a wide range of procedures, establishing them as trusted centers for cardiovascular treatments. On the other hand, ambulatory surgical centers are increasingly seen as an emerging segment, offering a streamlined approach to less complex heart procedures. These centers provide patients with quick access to care, lower costs, and a focus on minimally invasive techniques. As patients opt for faster recovery times and reduced overall expenses, the appeal of ambulatory surgical centers continues to grow, positioning them as a competitive alternative to traditional hospital settings.

    Get more detailed insights about US Structural Heart Devices Market

    Key Players and Competitive Insights

    The structural heart-devices market is characterized by a dynamic competitive landscape, driven by technological advancements and an increasing prevalence of heart diseases. Key players such as Edwards Lifesciences (US), Medtronic (US), and Abbott Laboratories (US) are at the forefront, each adopting distinct strategies to enhance their market positioning. Edwards Lifesciences (US) focuses on innovation, particularly in transcatheter heart valves, while Medtronic (US) emphasizes a broad portfolio that includes both surgical and minimally invasive solutions. Abbott Laboratories (US) is leveraging partnerships to expand its product offerings, particularly in the realm of left atrial appendage closure devices. Collectively, these strategies contribute to a competitive environment that is increasingly centered on technological innovation and patient-centric solutions.

    In terms of business tactics, companies are localizing manufacturing and optimizing supply chains to enhance efficiency and responsiveness to market demands. The market structure appears moderately fragmented, with several players vying for market share. However, the influence of major companies is substantial, as they set trends in product development and market strategies that smaller firms often follow.

    In October 2025, Edwards Lifesciences (US) announced the launch of its latest transcatheter aortic valve replacement (TAVR) system, which incorporates advanced imaging technology to improve procedural outcomes. This strategic move is significant as it not only reinforces Edwards' commitment to innovation but also positions the company to capture a larger share of the growing TAVR market, which is expected to expand due to increasing patient demand.

    In September 2025, Medtronic (US) revealed a partnership with a leading telehealth provider to integrate remote monitoring capabilities into its heart devices. This initiative is crucial as it aligns with the ongoing trend towards digital health solutions, enabling better patient management and potentially improving clinical outcomes. Such collaborations may enhance Medtronic's competitive edge by offering comprehensive solutions that address both device performance and patient care.

    In August 2025, Abbott Laboratories (US) expanded its manufacturing capabilities in the US to meet the rising demand for its heart devices. This expansion is indicative of Abbott's strategy to ensure supply chain reliability and responsiveness, which is increasingly vital in a market where timely access to innovative products can significantly influence patient outcomes. By bolstering its production capacity, Abbott positions itself to better serve healthcare providers and patients alike.

    As of November 2025, current trends in the structural heart-devices market include a pronounced shift towards digitalization, sustainability, and the integration of artificial intelligence (AI) in device development. Strategic alliances are becoming more prevalent, as companies recognize the value of collaboration in enhancing innovation and market reach. Looking ahead, competitive differentiation is likely to evolve, with a greater emphasis on technological advancements and supply chain reliability rather than solely on price. This shift suggests that companies that prioritize innovation and patient-centric solutions will be better positioned to thrive in an increasingly competitive landscape.

    Key Companies in the US Structural Heart Devices Market market include

    Industry Developments

    Recent developments in the US Structural Heart Devices Market have included significant advancements and investments as companies focus on innovative therapies. Notably, Medtronic has gained attention with its ongoing investment in the HeartWare product line designed for heart failure treatments. Abbott Laboratories continues to expand the adoption of its MitraClip device, which has shown substantial success in treating mitral valve regurgitation. In September 2023, Boston Scientific made headlines with a strategic partnership aimed at enhancing its structural heart portfolio, further solidifying its place in the market.

    Acquisitions have also been influential in the market landscape, such as Edwards Lifesciences acquiring a technology firm in June 2023 to accelerate its Research and Development efforts for transcatheter heart valves. Additionally, in the same month, LivaNova announced its merger with a leading cardiovascular technology organization, strengthening its market position and enhancing its product offerings.

    The growth in market valuations among key players reflects an overall expanding interest in structural heart therapies, with the total market value anticipated to surpass USD 12 billion by 2025 as more patients are diagnosed and treated, emphasizing the importance of alliances and innovation in this sector.

    Future Outlook

    US Structural Heart Devices Market Future Outlook

    The structural heart-devices market is projected to grow at a 6.62% CAGR from 2024 to 2035, driven by technological advancements, increasing prevalence of heart diseases, and rising healthcare expenditure.

    New opportunities lie in:

    • Development of minimally invasive surgical techniques for device implantation.
    • Expansion of telehealth services for remote patient monitoring and follow-up.
    • Investment in AI-driven analytics for personalized treatment plans and device optimization.

    By 2035, the market is expected to achieve substantial growth, driven by innovation and increasing demand.

    Market Segmentation

    US Structural Heart Devices Market Type Outlook

    • Transcatheter Aortic Valve Replacement
    • Mitral Valve Repair Devices
    • Left Atrial Appendage Closure Devices
    • Transcatheter Pulmonary Valve

    US Structural Heart Devices Market End User Outlook

    • Hospitals
    • Ambulatory Surgical Centers
    • Cardiology Clinics

    US Structural Heart Devices Market Indication Outlook

    • Aortic Stenosis
    • Mitral Regurgitation
    • Heart Failure
    • Pulmonary Valve Stenosis

    US Structural Heart Devices Market Procedure Type Outlook

    • Minimally Invasive
    • Surgical
    • Percutaneous

    Report Scope

    MARKET SIZE 2024 175.18(USD Million)
    MARKET SIZE 2025 186.77(USD Million)
    MARKET SIZE 2035 354.57(USD Million)
    COMPOUND ANNUAL GROWTH RATE (CAGR) 6.62% (2024 - 2035)
    REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
    BASE YEAR 2024
    Market Forecast Period 2025 - 2035
    Historical Data 2019 - 2024
    Market Forecast Units USD Million
    Key Companies Profiled Edwards Lifesciences (US), Medtronic (US), Abbott Laboratories (US), Boston Scientific (US), Cardinal Health (US), LivaNova (GB), Terumo Corporation (JP), JenaValve Technology (DE), AtriCure (US)
    Segments Covered Type, Procedure Type, Indication, End User
    Key Market Opportunities Advancements in minimally invasive procedures enhance growth potential in the structural heart-devices market.
    Key Market Dynamics Technological advancements and regulatory changes drive innovation in the structural heart-devices market.
    Countries Covered US

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    FAQs

    What is the current market size of the US Structural Heart Devices Market for the year 2024?

    The US Structural Heart Devices Market is expected to be valued at 191.5 million USD in 2024.

    What is the projected market size for the US Structural Heart Devices Market by 2035?

    By 2035, the market is anticipated to reach approximately 409.5 million USD.

    What is the expected compound annual growth rate (CAGR) for the US Structural Heart Devices Market from 2025 to 2035?

    The expected CAGR for the US Structural Heart Devices Market from 2025 to 2035 is 7.154 percent.

    Which type of structural heart devices holds the largest market share in 2024?

    In 2024, Heart Valve Devices account for the largest share at 80.0 million USD.

    What are the projected values for Annuloplasty Rings in the US Structural Heart Devices Market by 2035?

    The market for Annuloplasty Rings is projected to increase to 60.0 million USD by 2035.

    Who are the key players in the US Structural Heart Devices Market as of 2025?

    Major players in the market include Medtronic, Abbott Laboratories, and Boston Scientific.

    What segment is expected to show significant growth in the US Structural Heart Devices Market between 2025 and 2035?

    Occluders are expected to show substantial growth, increasing from 45.0 million USD in 2024 to 90.0 million USD in 2035.

    What challenges are faced by the US Structural Heart Devices Market in the coming years?

    Challenges include regulatory hurdles and the need for continued innovations to meet demand.

    What opportunities exist in the US Structural Heart Devices Market for new entrants?

    Opportunities include expanding technologies and growing awareness of heart health solutions.

    How is the current market expected to be impacted by technological advancements?

    Technological advancements are anticipated to drive market growth and enhance patient outcomes significantly.

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