Structural Heart Occlusion Devices Market Size, Share & Trends Analysis Report By Type (Left Atrial Appendage (LAA) Occlusion Devices, Atrial Septal Defect (ASD) Occluders), By End-use (Hospitals, Specialty Clinics), By Region, And Segment Forecasts

Published Date: May - 2025 | Publisher: MIR | No of Pages: 240 | Industry: healthcare | Format: Report available in PDF / Excel Format

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Market Size & Trends 

The size of the global structural heart occlusion devices market in 2024 was estimated to be USD 4.0 billion and is expected to develop at a rate of 7.0% CAGR between 2025 and 2035. The structural heart occlusion devices market is progressing on account of growing structural heart disease burden, heightened acceptance of less invasive therapies, and positive regulation and reimbursement updates. Increased clinical perception and procedural technologies are broadening the patient base eligible for treatment, supporting a robust positive growth pattern.

The growing incidence of structural heart conditions is a key growth driver for the market for structural heart occlusion devices. Atrial septal defects, patent foramen ovale, and left atrial appendage abnormalities are receiving increasing clinical notice as diagnostic equipment improves. American Heart Association's 2024 Statistical Update forecasts that the prevalence of atrial fibrillation (AF) in the U.S. will increase from an estimated 5.2 million in 2010 to 12.1 million in 2030, highlighting the increasing clinical demand for efficacious treatments. As diagnostic pathways converge and become more streamlined, the treatable patient population for occlusion therapies continues to grow comprehensively, forming a solid basis for market development.

With the increasing incidence of atrial fibrillation (AF) worldwide, Left Atrial Appendage Occlusion (LAAO) procedures are becoming increasingly popular in the Structural Heart Occlusion Devices market. LAAO is a non-pharmacologic option to oral anticoagulants in stroke prevention for patients with non-valvular AF, especially for those who are at high risk of bleeding. A February 2025 European Heart Journal Supplements article highlighted the increasing use of LAAO for patients with contraindications to long-term oral anticoagulant therapy (OAT). The article highlights that even though OAT is used to prevent stroke, some patients, particularly those with a history of bleeding events, are still at high risk of ischemic strokes.

Regulatory and reimbursement policies are increasingly driving the structural heart occlusion devices market. Positive policy environments are necessary to foster clinical acceptance, stimulate investment in innovation, and increase patient access to advanced treatments. In March 2025, the Centers for Medicare & Medicaid Services (CMS) approved the REDUCE-AF clinical trial under Coverage with Evidence Development (CED) to assess the LAmbre Plus Left Atrial Appendage Closure System. This is a reflection of ongoing regulatory focus on establishing strong clinical evidence to inform device use in patients with non-valvular atrial fibrillation.

Report Coverage & Deliverables

PDF report & online dashboard will help you understand

  • Competitive benchmarking
  • Historical data & forecasts
  • Company revenue shares
  • Regional opportunities
  • Latest trends & dynamics

Market Concentration & Characteristics

The market for structural heart occlusion devices is dominated by a high level of innovation resulting from the continuous R&D activities in catheter-based technologies, device miniaturization, and better biomaterials. The ongoing research and development activities continuously improve these devices to provide greater efficacy, safety, and user-friendly features, which are crucial in order to address increasing clinical needs. In June 2024, an article pointed to optimistic clinical results for the reSept ASD Occluder developed by atHeart Medical, a metal-free, bioresorbable device for atrial septal defect closure. The long-term data of the device, which were given at the CSI Frankfurt conference, attest to the potential for enhancing future transseptal treatment possibilities.

The extent of mergers and acquisitions (M&A) in the structural heart occlusion devices market is moderate. Market leaders are aggressively targeting strategic acquisitions for broadening product portfolios, developing technological capabilities, and improving access to markets. In November 2023, Johnson & Johnson MedTech (J&J MedTech) acquired Laminar, Inc., with emphasis on its Left Atrial Appendage Elimination (LAAX) device as a stroke-prevention solution in atrial fibrillation patients. The acquisition is a reinforcement in J&J MedTech's portfolio in the expanding MedTech market. The LAAX device offers a non-pharmacologic alternative to chronic oral anticoagulants for AFib patients unable to tolerate blood thinners.

Regulations play a critical role in shaping the structural heart occlusion devices industry, with a high impact on product development, approval timelines, and market entry strategies. Stringent regulatory requirements by agencies such as the FDA and EMA ensure that devices meet safety and efficacy standards before reaching the market. These policies are necessary in helping to ensure high-quality standards but may also extend the commercialization timeline for new devices, affecting the rate of innovation within the industry.

Product substitutes in the structural heart occlusion devices market are minimal. Although other treatments like pharmacological therapy for atrial fibrillation are available, occlusion devices provide a more specific, long-term solution for structural heart defect patients, particularly in high-risk groups. The specialized design of these devices and the quality of existing products minimize the danger of viable substitutes, making them a first choice in most clinical practices.

Geographical growth in the structural heart occlusion devices market is average, with companies investing more and more in global markets. The North American region continues to be the biggest market as it boasts of advanced healthcare facilities and high uptake levels. Firms are venturing into other emerging regions like the Asia Pacific and Latin America, where there is increasing awareness about healthcare and rising standards of medical facilities are prompting the need for cutting-edge treatments of heart diseases. As these regions embrace more advanced treatments, the industry is also set to expand and penetrate even further.

Type Insights

Left atrial appendage (LAA) occlusion devices segment was the largest at 49.7% in 2024 and is expected to advance with the highest CAGR during the forecast period based on the rising incidence of atrial fibrillation (AF), a condition that raises the risk of stroke. Non-valvular atrial fibrillation patients are at increased risk of developing blood clots in the left atrial appendage, which can move to the brain and lead to strokes. In January 2025, Structural Heart published an article on progress in left atrial appendage occlusion (LAAO), highlighting its efficacy in stroke risk reduction in atrial fibrillation patients. Device safety and effectiveness improvements put LAAO in the competition for oral anticoagulation, and it delves into its compatibility with other structural heart interventions.

Enhancements in occlusion technology have improved the performance and safety of these devices and expanded their application. Minimally invasive catheter-based treatment development and device innovation like that of the Watchman device contributed significantly to dominance in the segment. In March 2025, a JACC Clinical Electrophysiology article summarized the increasing role of left atrial appendage occlusion (LAAO) in stroke prevention for patients with atrial fibrillation. The article covered progress in LAAO devices, highlights challenges in patient selection, procedural methods, and post-procedure complications, and underscores continuous improvement in device efficiency and safety.

End-use Insights

The hospitals segment maintained the highest share of more than 65.2% in 2024 owing to increased need for highly advanced medical procedures that need special care and devices. Hospitals, especially those with cardiovascular units, are the most common sites for advanced structural heart interventions, including LAA occlusion and transcatheter valve procedures. These facilities possess the equipment, trained staff, and access to the newest technologies necessary for these high-risk procedures, and thus they are the ideal setting for device utilization. Chinese General Hospital and Medical Center's Heart Institute performed the second Left Atrial Appendage Occlusion (LAAO) procedure in the Philippines in October 2024, employing the Omega Eclipse device to avoid stroke in a patient with Atrial Fibrillation (AF).

The hospitals segment is expected to witness profitable growth over the forecast period. Hospitals are supported by a larger population base and an ongoing stream of patients requiring structural heart interventions, supporting their leadership in the structural heart occlusion devices market. An increase in the volume of patients suffering from diseases such as atrial fibrillation and heart valve disorders fuels the demand for successful treatment options within the hospitals. In March 2025, Journal of Perinatology published a paper on the management of patent ductus arteriosus (PDA) in 23 to 32 weeks' gestational age infants. The study presented augmented use of pharmacotherapy, particularly acetaminophen, and a decline in surgical ligation in favor of transcatheter PDA closure over a 12-year period.

Regional Insights

Market Analysis

North America dominated the structural heart occlusion devices market with a share of 41.1% in 2024, driven by strong demand for advanced medical technologies, particularly in congenital heart defect treatment. In October 2024, Vessel Plus published a review on transcatheter closure of patent ductus arteriosus (PDA), highlighting the use of occlusion techniques like buttoned devices, Gianturco coils, and Amplatzer devices. These innovations reflect the broader trend in North America towards embracing cutting-edge technologies to treat complex cardiovascular conditions.

U.S. Structural Heart Occlusion Devices Market Trends

The U.S. continues to drive growth in North America's structural heart occlusion devices market through advancements in diagnostic and intervention technologies. In November 2024, Revista Cardiovascular de Medicina published a review on the diagnosis and management of ventricular septal defects (VSDs). The article highlighted the importance of echo-Doppler studies for assessing clinical significance and discussed surgical and percutaneous treatments, including the use of Amplatzer VSD Occluders for moderate- to large-sized defects.

Europe Structural Heart Occlusion Devices Market Trends

The structural heart occlusion devices market in Europe held the second-largest revenue market share in 2024. In Europe, the growing demand for safe and effective minimally invasive procedures has driven innovation in the medical device sector. In April 2024, Medicina published a case report on a rare complication of patent foramen ovale (PFO) closure. The study highlighted an unintentional detachment of the closure device, which migrated into the abdominal aorta.

Germany's structural heart occlusion devices market is anticipated to grow at a significant rate in 2024 driven by increasing adoption of innovative therapies. In August 2024, European Heart Journal published an article reviewing the current status and perspectives on left atrial appendage closure (LAAC) for stroke prevention in atrial fibrillation (AF). The article highlights the growing importance of LAAC as an alternative to oral anticoagulation, especially for patients with a high risk of bleeding. It discusses the efficacy and safety of catheter-based LAAC, with advances in device technology, imaging, and implantation techniques improving outcomes.

The structural heart occlusion devices market in UK held a significant market share in 2024 driven by advancements in treatment options. In September 2022, a study from the UK National Registry on post-infarction ventricular septal defects (VSD) was presented at TCT 2022. It was found that while there was no significant difference in 5-year all-cause mortality between surgical and percutaneous treatments, the surgical group had lower in-hospital mortality (44.2% vs. 55%).

Asia Pacific Structural Heart Occlusion Devices Market Trends

The Asia Pacific region is expected to grow fastest during the forecast period. Rapid innovation in device design and rising stroke prevention initiatives are driving Asia Pacific’s structural heart occlusion devices market growth. In March 2025, an editorial in JACC Asia discussed the advancements and ongoing challenges in left atrial appendage occlusion (LAAO) as a stroke prevention method for atrial fibrillation. While newer devices have improved safety, issues such as peridevice leakage and device-related thrombus remain significant. The search for an ideal LAA occluder continues, with newer-generation devices showing promise in reducing complications.

China structural heart occlusion devices market accounted for the largest share in the Asia Pacific region in 2024. Rising innovation and strong clinical adoption are driving growth in China's structural heart occlusion devices market. In January 2025, BMC Cardiovascular Disorders published a study comparing the WATCHMAN and LACbes devices for left atrial appendage closure in atrial fibrillation patients. The LACbes device showed a lower stroke rate (1.8% vs. 3.7%) and fewer bleeding complications (1.8% vs. 9.5%) compared to WATCHMAN, indicating similar efficacy and safety for stroke prevention.

The structural heart occlusion devices market in Japan held the largest market share in the Asia Pacific region. Strong preference for next-generation devices is boosting Japan’s dominance in the structural heart occlusion devices market.  In April 2024, Circulation Journal published a study comparing outcomes between the WATCHMAN FLX and WATCHMAN 2.5 devices in Japanese patients undergoing percutaneous left atrial appendage closure. The WATCHMAN FLX showed higher procedural success, lower pericardial effusion rates, and significantly reduced bleeding events at one year compared to the older device.

The India structural heart occlusion devices market is experiencing significant growth driven by advancements in minimally invasive procedures. In July 2023, Kauvery Hospital in Chennai performed India's first intracardiac echo-guided Lambre Left Atrial Appendage (LAA) closure on an 80-year-old patient with atrial fibrillation. The minimally invasive procedure reduced stroke risk without requiring blood-thinning medication.

Latin America Structural Heart Occlusion Devices Market Trends

The Latin America structural heart occlusion devices market is growing due to rising adoption of minimally invasive cardiac procedures, increasing prevalence of atrial fibrillation and congenital heart defects, and expanding access to specialized cardiac care. Improving healthcare infrastructure and the entry of advanced device technologies are also accelerating market momentum across the region.

Brazil's structural heart occlusion devices market is expanding due to growing clinical validation and procedural success rates fueling Brazil’s structural heart occlusion devices market expansion. In October 2022, the article "Left Atrial Appendage Closure with the LAmbre Device - Initial Multicenter Experience in Brazil" was published in Arquivos Brasileiros de Cardiologia. The study on 51 patients showed a 100% procedural success rate with no deaths or strokes during an 18-month follow-up, highlighting the LAmbre device's safety and efficacy in stroke prevention for atrial fibrillation patients.

Middle East & Africa Structural Heart Occlusion Devices Market Trends

The MEA structural heart occlusion devices market is expected to grow lucratively due to increasing investments in healthcare infrastructure, a rising burden of cardiovascular diseases, and greater availability of specialized interventional cardiology services. Emerging private sector initiatives and the gradual uptake of next-generation occlusion technologies are further fueling regional expansion.

Saudi Arabia's structural heart occlusion devices market is expected to grow at a significant CAGR over the forecast period. In Saudi Arabia, the increasing adoption of advanced medical technologies, growing healthcare infrastructure, and a rising prevalence of cardiovascular diseases are key drivers in the market for cardiac devices. In March 2023, Journal of the Saudi Heart Association reported a case of atrial septal defect (ASD) device embolization after MRI, leading to cyanosis and shortness of breath. The incident highlighted concerns over MRI safety with implanted cardiac devices, relevant to interventional cardiology markets.

Key Structural Heart Occlusion Devices Company Insights

Notable companies in the industry include Abbott, Boston Scientific Corporation, and Medtronic. Their strategies focus on analyzing the strengths and weaknesses of leading competitors, predicting upcoming market trends, opportunities, and challenges, and making informed decisions based on emerging technologies and evolving consumer demands. For example, Occlutech and Lifetech Scientific are rising players in the structural heart occlusion devices market.

Key Structural Heart Occlusion Devices Companies

The following are the leading companies in the structural heart occlusion devices market. These companies collectively hold the largest market share and dictate industry trends.

Recent Developments

  • In October 2024, Conformal Medical launched the GLACE Study in Europe to evaluate its next-gen CLAAS AcuFORM device for Left Atrial Appendage Occlusion (LAAO) using intracardiac echocardiography (ICE) imaging. The device simplifies LAAO procedures with just two sizes, aiming to reduce radiation and eliminate general anesthesia, potentially transforming clinical practice for stroke prevention in atrial fibrillation patients.

  • In September 2024, MicroPort CardioFlow Medtech Corporation announced the accelerated rollout of its AnchorMan Left Atrial Appendage Closure (LAAC) System in China. Approved by the National Medical Products Administration (NMPA) in January 2024, the device has already been implanted in 41 cases across 12 provinces. The system combines the benefits of both open and closed LAAC devices, providing enhanced stability and minimizing tissue damage, with plans for global expansion underway, including a pending CE registration for the European market.

  • In January 2024, Occlutech secured FDA approval for its ASD Occluder and Pistol Pusher delivery system, designed to address atrial septal defects (ASDs). This self-expanding nitinol device facilitates the transcatheter closure of ostium secundum-type ASDs, providing a permanent solution for patients.

Structural Heart Occlusion Devices Market Report Scope

Report Attribute

Details

Market size value in 2025

USD 4.3 billion

Revenue forecast in 2030

USD 6.0 billion

Growth rate

CAGR of 7.0% from 2025 to 2035

Actual data

2018 - 2024

Forecast period

2025 - 2035

Quantitative units

Revenue in USD million/billion, and CAGR from 2025 to 2035

Report coverage

Revenue forecast, company ranking, competitive landscape, growth factors, and trends

Segments covered

Type, end-use, region

Regional scope

North America; Europe; Asia Pacific; Latin America; MEA

Country scope

U.S.; Canada; Mexico; UK; Germany; France; Italy; Spain; Denmark; Sweden; Norway; Japan; China; India; Australia; Thailand; South Korea; Brazil; Argentina; South Africa; Saudi Arabia; UAE; Kuwait

Key companies profiled

Abbott; Boston Scientific Corporation; Occlutech; Lifetech Scientific; Medtronic; W. L. Gore & Associates; Lepu Medical Technology (Beijing)Co.,Ltd; Emtree Medical (Cardia Inc.); Biosense Webster (Johnson & Johnson); PFM Medical GMBH

Customization scope

Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope.

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Global Structural Heart Occlusion Devices Market Report Segmentation

Type Outlook (Revenue, USD Million, 2018 - 2035)

    • Left Atrial Appendage (LAA) Occlusion Devices

    • Atrial Septal Defect (ASD) Occluders

    • Patent Ductus Arteriosus (PDA) Occlusion Devices

    • Others

  • End-use Outlook (Revenue, USD Million, 2018 - 2035)

    • Hospitals   

    • Specialty clinics

    • Academic and Research Institutes

  • Regional Outlook (Revenue, USD Million, 2018 - 2035)

    • North America

      • U.S.

      • Canada

      • Mexico

    • Europe

      • UK

      • Germany

      • France

      • Italy

      • Spain

      • Denmark

      • Sweden

      • Norway

    • Asia Pacific

      • Japan

      • China

      • India

      • South Korea

      • Australia

      • Thailand

    • Latin America

      • Brazil

      • Argentina

    • Middle East & Africa

      • South Africa

      • Saudi Arabia

      • UAE

      • Kuwait

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