Press release
United States Structural Heart Devices Market 2025 | Growth Drivers, Key Players & Investment Opportunities
Market Size and GrowthThe Global Structural Heart Devices Market reached US$ 14.79 billion in 2024 and is expected to reach US$ 28.84 billion by 2033, growing at a CAGR of 8.0% during the forecast period 2025-2033, according to DataM Intelligence report.
Key Development:
United States: Recent Industry Developments
✅ In May 2025, Edwards Lifesciences received U.S. FDA approval for its SAPIEN 3 Transcatheter Aortic Valve Replacement (TAVR) system to treat asymptomatic patients with severe aortic stenosis. This marks the first FDA clearance for TAVR in this patient group, significantly broadening the treatment base.
✅ In April 2025, Edwards Lifesciences announced that its SAPIEN M3 mitral valve replacement system received CE Mark approval. The device is approved for treating patients with moderate-to-severe or severe mitral regurgitation (MR) who are not suitable for surgery or transcatheter edge-to-edge repair (TEER). The SAPIEN M3 is the first transcatheter mitral valve replacement system approved for use through a transfemoral approach, offering a minimally invasive option for patients with limited treatment choices.
✅ In March 2025, Abbott announced new results from its TRILUMINATETM Pivotal trial, showing that the TriClipTM TEER system provides significant and lasting improvement in tricuspid regurgitation (TR) after two years. The data also showed that TriClip reduced heart failure-related hospitalizations and improved long-term quality of life compared to standard medical therapy.
Japan: Recent Industry Developments
✅ In August 2025, Corcym announced that its Perceval Plus sutureless aortic heart valve was used in a first-ever robotic surgery in Ohio. This marks a significant advancement in minimally invasive heart valve replacement procedures.
✅ In July 2025, Johnson & Johnson MedTech launched its VARIPULSETM Platform across Asia-Pacific, advancing atrial fibrillation treatment. The VARIPULSETM Platform is the first Pulsed Field Ablation (PFA) system fully integrated with the CARTOTM 3 electroanatomical mapping system, designed to drive efficiency, reproducibility, and procedural accuracy.
✅ In July 2025, an investment agreement for a 3% stake in Meril (Micro Life Sciences) was signed by the Abu Dhabi Investment Authority (ADIA) with a $200 million investment. Meril is a well-known medical device company that focuses on cardiovascular, structural heart, surgical robotics, endo-surgery, orthopaedics, and in-vitro diagnostics.
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Structural Heart Devices are medical implants and tools designed to treat defects or abnormalities in the heart's structure, such as valves, septal defects, or aneurysms. They include devices like heart valves, occluders, and stents, improving cardiac function, patient outcomes, and quality of life through minimally invasive or surgical interventions.
Recent Mergers and Acquisitions
✅ In August 2025, the U.S. Federal Trade Commission (FTC) filed a lawsuit to block Edwards Lifesciences' $945 million acquisition of JenaValve Technology Inc., citing potential harm to competition in the market for transcatheter aortic valve replacement (TAVR) devices. Edwards disagrees with the FTC's stance, claiming the decision could restrict treatment availability.
✅ In May 2025, Abbott Laboratories announced that its structural heart and heart failure segments were key drivers of its 13% annual growth in medical devices. This growth was attributed to strategic acquisitions and innovations in the structural heart space.
✅ In February 2025, Stryker Corporation acquired Inari Medical for approximately $5 billion. Inari's portfolio includes nitinol-enabled devices and systems like the FlowTriever, designed for the removal of pulmonary emboli, enhancing Stryker's offerings in structural heart interventions.
Key Players:
-> Medtronic, Abbott, JenaValve, Artivion, Inc., Boston Scientific Corporation, Micro Interventional Devices, Biomerics, TORAY INDUSTRIES, INC., Occlutech LLC, Shanghai MicroPort Medical (Group) Co.Ltd. among others.
Growth Forecast Projected:
The Global Structural Heart Devices Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2033. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.
Research Process:
Both primary and secondary data sources have been used in the global Structural Heart Devices Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.
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Key Segments:
➥ By Repair Devices: Occluders, Annuloplasty Devices, Valvuloplasty Devices, Others
➥ By Replacement Devices: Mechanical Valve, Bioprosthetic Valve, TAVR
➥ By Application: Atrial Septal Defect, Aortic Valve Stenosis, Ventricular Septal Defects, Mitral Regurgitation, Others
➥ By End User: Hospitals, Ambulatory Surgical Centers, Others
Regional Analysis for Structural Heart Devices Market:
⇥ North America (U.S., Canada, Mexico)
⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)
⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)
⇥ South America (Colombia, Brazil, Argentina, Rest of South America)
⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)
Benefits of the Report:
Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.
Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.
Chapter 3: Offers an in-depth look at the competitive landscape among Structural Heart Devices producers, including revenue shares, strategic moves, and recent mergers and acquisitions.
Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.
Chapters 5 & 6: Analyze Structural Heart Devices revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.
Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.
Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.
Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.
Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.
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FAQ
What is the current size of the Structural Heart Devices Market?
A: In 2024, the Structural Heart Devices Market was valued at US$ 14.79 billion , reflecting its strong industry presence.
Q2: How large is the Structural Heart Devices Market expected to be by 2033?
A: By 2033, industry forecasts suggest the Structural Heart Devices Market will grow to around S$ 28.84 billion, demonstrating significant expansion.
Q3: What is the growth rate of the Structural Heart Devices Market?
A: The market is projected to expand at a compound annual growth rate (CAGR) of 8.0% during the forecast period from 2025 to 2033.
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