United States Congenital Heart Defect Devices Market: VSD/ASD Closure & Fastest Growth Forecast - 2025-2033 | Leading Companies - Lepu Medical Technology Co., Ltd., Abbott Laboratories, Becton, Dickinson and Company, Medtronic

Market Size and Forecast:

Global Congenital Heart Defect Devices Market reached US$ 2.8 billion in 2022 and is expected to reach US$ 4.6 billion by 2030, growing with a CAGR of 6.4% during the forecast period 2023-2030.

DataM Intelligence has published a new research report on "Congenital Heart Defect Devices Market Size 2025". The report explores comprehensive and insightful Information about various key factors like Regional Growth, Segmentation, CAGR, Business Revenue Status of Top Key Players and Drivers. The purpose of this report is to provide a telescopic view of the current market size by value and volume, opportunities, and development status.

Latest M&A Activites:

Growth is primarily driven by increasing prevalence of congenital heart diseases, enhanced prenatal screening initiatives, and rising awareness leading to early diagnosis and intervention.

The market benefits from advances in minimally invasive technologies, biomaterials, and integration of AI and machine learning in cardiac devices.

North America leads the market due to advanced healthcare infrastructure and supportive government programs; emerging economies in Asia-Pacific show rapid growth driven by expanding access to cardiac care.

Key product types include septal defect occluders, patent ductus arteriosus devices, stents, and catheters used for structural heart repairs.

Recent regulatory approvals include the US FDA clearance of the Minima Growth Stent by Renata Medical, designed for use in infants and children with narrow pulmonary artery or aorta.

Partnerships such as the collaboration between Sahajanand Medical Technologies and HeartX are fostering innovation in device development for congenital heart defects.

Leading companies include Abbott Laboratories, AstraZeneca, Biotronik, Edwards Lifesciences, GE Healthcare, Medstar Health, and PFM Medical, actively investing in R&D and strategic expansions.

Minimally invasive procedures employing these devices are increasing due to reduced recovery times and complications, enhancing patient preference and market growth.

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Key Players:

Lepu Medical Technology Co., Ltd.
Abbott Laboratories
Becton, Dickinson and Company
Medtronic
Boston Scientific Corporation
Biotronik
Edwards Lifesciences Corporation.
OSYPKA MEDICAL
ABIOMED.
MEDICO S.R.L.

Key Industry Developments:

USA

August 22, 2025: The FDA approved Renata Medical's Minima Growth Stent, a cutting-edge device designed specifically for children with CHD. This stent mimics the natural growth of blood vessels, aiming to reduce the need for future invasive treatments as the child develops.

Ongoing Trend (Jul-Sept 2025): The market saw cardiovascular devices, including CHD devices, continue to lead the FDA's Breakthrough Device Program (with 243 total designations and 160 cleared devices), accelerating the regulatory pathway for innovative solutions like specialized catheters and occluders.

Japan

August 19, 2025: The MHLW revised its Pharmaceutical and Medical Device Act (PMD Act), strengthening compliance obligations for manufacturers, including the requirement to appoint a Supply System Manager. This aims to improve the supply stability of critical devices like CHD implants.

Ongoing Trend (Jul-Sept 2025): The MHLW continued to increase the required clinical evidence for achieving premium reimbursement pricing for innovative medical devices. This puts pressure on CHD device manufacturers to demonstrate superior efficacy and safety to justify high pricing in the sophisticated Japanese market.

Growth Forecast Projected:

The Global Congenital Heart Defect Devices Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2032. 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 Congenital Heart Defect 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 Defect Type: Atrial Septal Defect, Ventricular Septal Defect, Atrioventricular Septal Defect, Tricuspid Atresia, Truncus Arteriosus, Others
➥ By Device Type: Catheters, Pacemakers, Implantable Cardioverter Defibrillators, Biventricular Devices, Implanted Cardiac Loop Recorders, Others
➥ By End-User: Hospitals, Specialty Clinics, Academic and Research Institutes, Others

Regional Analysis for 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 Congenital Heart Defect Devices Market 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 Congenital Heart Defect Devices Market 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's

Q1: What is the current size of the Congenital Heart Defect Devices Market?

A: The Congenital Heart Defect Devices Market stood at US$ 2.8 billion in 2023 and is set to experience remarkable growth, reaching US$ 4.6 billion by 2031

Q2: How fast is the Congenital Heart Defect Devices Market growing?

A: The Market is on an impressive growth trajectory, expected to expand at a CAGR of 6.4% from 2025 to 2032

Q3: Which regions are dominating the Congenital Heart Defect Devices Market and which are fastest-growing?

A: North America dominating the Congenital Heart Defect Devices Market.

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