United States Heart Valve Devices Market 2033 | Growth Drivers, Trends & Market Forecast, Competitive Landscape & Investment Opportunities

Market Size and Growth

The Global Heart Valve Devices Market reached US$ 12.76 billion in 2024 and is expected to reach US$ 34.6 billion by 2033, growing at a CAGR of 12.34% during the forecast period 2025-2033.

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Key Development:

United States: Recent Heart Valve Device Developments

✅ In December 2025, Anteris Technologies received FDA clearance to launch its global pivotal PARADIGM clinical trial for the DurAVR® Transcatheter Heart Valve, a next-generation biomimetic valve being studied head-to-head with existing TAVR systems to support future U.S. commercialization. This milestone enables patient enrollment across the U.S., Europe, and Canada and advances evidence generation for regulatory approval pathways.

✅ In November 2025, the FDA approved Anteris's DurAVR® THV Global Pivotal Trial (PARADIGM), allowing the company to commence U.S. clinical evaluation of its novel transcatheter aortic valve for patients with severe calcific aortic stenosis and support future PMA submissions. This represents a key regulatory step toward introducing new structural heart technology in the U.S. market.

✅ In October 2025, Anteris reported positive clinical outcomes and one-year data on its DurAVR transcatheter heart valve at a major cardiology conference, highlighting favorable hemodynamic performance and procedural results that could influence future regulatory and clinical adoption.

✅ In October-November 2025, broader structural heart technology discussions at major industry meetings including outcomes from comparative studies of new TAVR devices underscored evolving evidence and innovation in aortic valve replacement procedures that may inform device development and clinical practice.

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Japan: Recent Heart Valve Device Developments

✅ In November 2025, clinical collaborations and early platform development research including catheter delivery system advancements integrating mapping visualization technologies progressed toward future structural heart therapy applications, suggesting ongoing investment in next-generation cardiac interventions.

✅ In late 2025, Japanese regulatory and clinical communities continued preparing for accelerated evaluation and adoption of minimally invasive heart valve replacements, driven by demographic demand and alignment with global trial insights and device evidence.

✅ In October-November 2025, structural heart device innovations and clinical insights including broader reports from international valve trials and procedural data were presented at global cardiology forums attended by Japanese clinicians, contributing to local knowledge and expected adoption of advanced TAVR technologies in Japan.

✅ In September 2025, Scandinavian Real Heart received Japanese patent approval for automatic control technology used in its total artificial heart device, a procedural innovation that supports next-generation cardiac support systems relevant to structural heart device ecosystems in Japan.

Key Players:

=> Abbott, Medtronic, Artivion, Inc., Boston Scientific Corporation, Micro Interventional Devices, Edwards Lifesciences Corporation, Sorin Medical Group, TTK Heartvalve, JenaValve, Lepu Medical Technology (Beijing)Co., Ltd. among others.

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Emerging Players

=> Capstan Medical, Vesalius Cardiovascula, and Orchestra BioMed among others

Key Segments:

By Heart Valve Replacement Devices

Mechanical Valve - 35% share, durable and long-lasting, preferred in younger patients.
Bioprosthetic Valve - 40% share, widely adopted due to lower anticoagulation requirements.
TAVR (Transcatheter Aortic Valve Replacement) - 25% share, minimally invasive, increasingly used for high-risk patients.

By Position

Mitral Valve - 30% share, replacement and repair focused on mitral regurgitation and stenosis.
Aortic Valve - 50% share, high adoption for aortic stenosis, including TAVR procedures.
Others - 20% share, includes tricuspid and pulmonary valve interventions.

By Heart Valve Repair Devices

Surgical Valve Repair Devices - 45% share, standard treatment for mitral and aortic valve repairs.
Balloon Valvuloplasty Devices - 30% share, minimally invasive option for stenotic valves, especially in pediatrics.
TMVR (Transcatheter Mitral Valve Repair) - 25% share, emerging technology for high-risk patients and those unsuitable for surgery.

By End-User

Hospitals - 70% share, primary adopters providing surgical and transcatheter interventions.
Ambulatory Surgical Centers - 20% share, focused on minimally invasive procedures.
Others - 10% share, includes specialty cardiac clinics and research centers.

By Region

North America - 40% share, driven by advanced healthcare infrastructure and early adoption of TAVR/TMVR.
Europe - 30% share, high adoption of bioprosthetic valves and surgical repair devices.
Asia Pacific - 20% share, growing rapidly due to increasing cardiovascular disease prevalence and infrastructure investments.
Latin America - 5% share, expanding access to heart valve therapies in Brazil, Mexico, and Argentina.
Middle East & Africa - 5% share, emerging adoption through private hospitals and government initiatives.

FAQ

What is the current size of the Heart Valve Devices Market?

A: In 2024, the Heart Valve Devices Market was valued at US$ 12.76 billion, reflecting its strong industry presence.

Q2: How large is the Heart Valve Devices Market expected to be by 2033?

A: By 2033, industry forecasts suggest the Heart Valve Devices Market will grow to around US$ 34.6 billion, demonstrating significant expansion.

Q3: What is the growth rate of the Heart Valve Devices Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 12.34% during the forecast period from 2025 to 2033.

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