Structural Heart Devices Market (2026 - 2033)

Structural Heart Devices Market Summary

The global structural heart devices market size was valued at USD 18.6 billion in 2025 and is projected to grow from USD 21.1 billion in 2026 to USD 51.0 billion in 2033, at a CAGR of 13.5% from 2026 to 2033. The North America structural heart devices industry dominated the global market in 2025, accounting for the largest revenue share of 52.5%. The rising prevalence of valvular heart disease and the growing preference for less invasive procedures primarily drive market growth.

Market Dynamics

The rising prevalence of cardiovascular diseases (CVDs) in the U.S., including conditions such as arrhythmias and heart failure, is significantly driven by several key factors. A sedentary lifestyle has become increasingly common, with many individuals engaging in insufficient physical activity, which contributes to obesity and related health issues.  According to the American Heart Association, in January 2024, the U.S. reported 931,578 deaths linked to cardiovascular disease, nearly 3,000 higher than the previous year, with the age-adjusted death rate climbing to 233.3 per 100,000 people, reflecting a 4.0% increase. These statistics underscore a growing need for advanced treatment options, such as transcatheter heart valves and left atrial appendage closure devices, to manage high-risk patients and reduce mortality linked to structural heart conditions.

According to an Oxford Academic article published in January 2025, the global age-standardized prevalence of cardiovascular disease stands at approximately 7,179 cases per 100,000 individuals, highlighting the substantial and persistent global burden of heart-related conditions. The rising prevalence of cardiovascular conditions highlights the need for timely interventions. Structural heart devices are key in managing valvular and congenital heart diseases. With a focus on early diagnosis and personalized care, technologies such as transcatheter valves and septal closure devices are improving outcomes and minimizing the need for invasive surgeries.

Technologically advanced products launched by key players drive the market's growth. For instance, in October 2024, Medtronic secured CE mark approval for its Evolut FX+ transcatheter aortic valve replacement (TAVR) system to treat patients with symptomatic severe aortic stenosis. This European clearance follows earlier approval from the U.S. Food and Drug Administration in March. The Evolut FX+ system introduces significant design upgrades to improve coronary reaccess. Notably, it features coronary access windows approximately four times larger than those in previous Evolut models. This design enhancement improves catheter maneuverability, especially critical for patients who may need future coronary procedures. Physicians are increasingly focused on long-term patient care as TAVR becomes more common in younger populations. Improved coronary accessibility supports rapid intervention in urgent cases such as heart attacks, potentially improving patient outcomes and procedural efficiency.

Analyst Perspective

The increasing inclination toward minimally invasive, transcatheter interventions over traditional open-heart surgeries is the primary growth driver for this market. Emerging trends in care delivery, such as the use of localized ambulatory surgical centers for various procedures, are also likely to influence the industry's future course during the forecast period. Innovation, the entry of start-ups with disruptive technologies, acquisition efforts, and investment-backed product development, is likely to result in a highly competitive environment and several novel technology launches in the coming years.

Type Insights

The TAVR (Transcatheter Aortic Valve Replacement) segment accounted for the largest revenue share of 53.4% in 2025. Increasing cardiovascular disease, government initiatives, and technological advancements drive the market's growth. For instance, in December 2024, Sahajanand Medical Technologies (SMT) took a significant step forward in strengthening its international footprint by launching its Hydra Transcatheter Aortic Valve Replacement (TAVR) system in Mexico. This strategic expansion reflects the company’s vision to bring advanced, minimally invasive cardiac therapies to patients worldwide. The introduction of the Hydra TAVR system is a part of SMT’s ongoing efforts to provide innovative and accessible solutions for the treatment of structural heart diseases, particularly severe aortic stenosis.

The SAVR segment is anticipated to grow significantly over the forecast period. Rising CVD cases, an aging population, and technological advancements drive market growth. For instance, in March 2025, Corcym achieved a notable milestone with the U.S. FDA approval of an enhanced version of its Perceval Plus sutureless surgical aortic valve, marking a significant advancement in surgical heart valve technology. This newly redesigned valve incorporates several vital improvements to optimize the implantation process and long-term valve performance. Key enhancements include the integration of laser-cut leaflets, which offer greater precision and uniformity in leaflet structure, and refined thread holes that improve surgical handling and durability. Moreover, the valve utilizes a zero-pressure fixation process, a novel technique that minimizes mechanical stress on the valve leaflets during manufacturing. This approach helps preserve leaflet integrity and may enhance valve longevity and performance.

Regional Insights

North America dominated the structural heart devices market with a 52.5% revenue share in 2024, driven by rising CVD prevalence, increasing heart valve cases, and government funding and awareness campaigns, which are fueling growth in the prosthetic heart valve market. According to an article published by the American Heart Association, Inc. in October 2024, the CDC awarded USD 8.4 million in grants to the American Heart Association to launch national campaigns focused on heart valve disease education.

U.S. Structural Heart Devices Market Trends

The structural heart devices market in the U.S. dominated North America in 2025. Increasing CVD cases, rising heart valve cases, and the introduction of technologically advanced products by the key player drive the market's growth. For instance, in October 2024, Edwards Lifesciences announced findings from its EARLY TAVR Trial, which assessed outcomes in patients with asymptomatic severe aortic stenosis. The study revealed that early transcatheter aortic valve replacement (TAVR) significantly reduced adverse events, from 26.8% in the treated group to 45.3% in the clinical monitoring group, over a median follow-up period of 3.8 years. These results, presented at the TCT symposium and published in The New England Journal of Medicine, underscore the growing preference for early intervention and the continued clinical validation of TAVR technologies across the region.

Europe Structural Heart Devices Market Trends

The structural heart devices market in Europe is expected to grow significantly over the forecast period. Increasing CVD prevalence, rising heart valve cases, and technological advancement drive the market's growth. In March 2025, Medtronic announced five-year data from the landmark Evolut Low Risk Trial. It confirmed the long-term safety and structural durability of its transcatheter aortic valve replacement (TAVR) system. Such developments highlight the growth potential of this regional industry. The Italian structural heart devices industry is expected to grow significantly during the forecast period. Increasing CVD cases and technological advancements are driving market growth. According to a Frontiers article published in April 2024, the incidence of CVD in Italy is approximately 12.9%, nearly double the global average of 6.6%. This elevated disease burden is driven by lifestyle and metabolic risk factors, including high rates of smoking, physical inactivity, and poor adherence to the traditional Mediterranean diet. In addition, the widespread presence of hypertension, dyslipidemia, and obesity further accelerates the onset of structural heart conditions. These trends fuel demand for advanced cardiac interventions, such as transcatheter and surgical valve replacements.

Latin America Structural Heart Devices Market Trends

The structural heart devices market in Latin America is witnessing a gradual shift toward minimally invasive procedures, driven by the rising adoption of transcatheter valve technologies. Growing awareness, improved healthcare infrastructure, and increased investment in cardiovascular care support market expansion. Countries such as Brazil and Argentina are seeing rising demand for TAVR and mitral repair solutions, reflecting broader regional efforts to modernize cardiac treatment. The Brazilian market is witnessing steady growth, driven by the country’s high cardiovascular disease prevalence and government initiatives.

Middle East and Africa Structural Heart Devices Market Trends

The structural heart devices market in MEA is witnessing significant growth, driven by rising cardiovascular disease prevalence, improved access to healthcare infrastructure, and greater awareness of minimally invasive cardiac interventions. Countries such as the UAE and Saudi Arabia are investing in advanced cardiac care centers, boosting demand for transcatheter therapies and next-generation valve repair systems. In addition, collaborations with global medtech firms and the growth of medical tourism in select regions further support the adoption of structural heart technologies across the MEA market.

Saudi Arabia structural heart devices market is anticipated to grow considerably during the forecast period. Increasing CVD cases and technological advancements are driving market growth. According to a March 2024 article published in BMC Cardiovascular Diseases, CVD represents a growing health challenge in Saudi Arabia, with a recent national survey reporting a prevalence of 1.6% among individuals aged 15 and older, exceeding the global average of roughly 235 per 100,000. This translates to approximately 236,800 adults diagnosed with CVD, with rates notably higher in men (1.9%) compared to women (1.4%). The close association between CVD and structural heart defects, especially in older people, and the demand for advanced diagnostic tools and structural heart interventions, such as transcatheter valves, mitral repair devices, and septal occluders, are expected to increase significantly in Saudi Arabia.

Key Structural Heart Devices Company Insights

Key structural heart devices industry participants focus on devising innovative growth strategies, such as expanding their product portfolios, pursuing partnerships and collaborations, engaging in mergers and acquisitions, and expanding their business footprints.

Key Structural Heart Devices Companies

The following key companies have been profiled for this study on the structural heart devices market.

• Boston Scientific Corporation

• Medtronic plc

• Edwards Lifesciences Corporation

• Abbott Laboratories

• ST. JUDE MEDICAL

• Biomerics

• Comed BV

• LivaNova PLC

• JenaValve Technology, Inc.

• CardioKinetix

Recent Development

• In May 2025, Edwards Lifesciences gained FDA approval from the United States Food and Drug Administration (FDA) for its SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA TAVR systems to be used for treating individuals with severe aortic stenosis that is asymptomatic. This became the first FDA approval for a TAVR treatment for asymptomatic individuals.

• In May 2025, Medtronic obtained CE Mark clearance for the use of its Evolut PRO+ and Evolut FX TAVI devices in a new indication, allowing cardiologists to perform repeat TAVIs by inserting a new Evolut valve into a failed transcatheter aortic valve, regardless of the manufacturer. The development paves the way for improved patient care by providing more options for patients with heart valve failure. 

Structural Heart Devices Market Report Scope

Global Structural Heart Devices Market Report Segmentation

This report forecasts revenue growth and analyzes the latest trends in each sub-segment from 2021 to 2033 at the global, regional, and country levels. For this report, Grand View Research has segmented the global structural heart devices market based on type and region:

• Type Outlook (Revenue USD Million, 2021 - 2033)

  • TAVR (Transcatheter Aortic Valve Replacement)

  • SAVR (Surgical Aortic Valve Replacement)

  • Mitral Repair (Annuloplasty)

  • LAAC (Left Atrial Appendage Closure)

• Regional Outlook (Revenue, USD Million, 2021 - 2033)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait