Market Outlook

The Patent Foramen Ovale Closure Device market was valued at USD 274.22 million in 2023 and is projected to grow to USD 433.56 million by 2030, with a compound annual growth rate (CAGR) of 7.0% from 2024 to 2030. The Patent Foramen Ovale (PFO) closure device market refers to the segment of medical devices designed to treat PFO, a condition where a small opening between the heart's upper chambers fails to close after birth, potentially leading to stroke and other complications.

Patent Foramen Ovale Closure Device market

The growing number of strokes linked to PFO, growing patient and healthcare professional knowledge of the illness, and improvements in minimally invasive surgical methods are some of the factors propelling this market. Furthermore, the need for efficient PFO closure solutions is fueled by the aging population, which is increasingly prone to cardiovascular disorders.

The creation of novel closure devices that improve efficacy and safety, along with advantageous reimbursement regulations, present opportunities. As healthcare costs rise and medical infrastructure improves, emerging markets offer substantial development opportunity. Further research and clinical studies to better understand the long-term advantages of PFO closure may also result in a wider range of indications and applications for these devices. Because more people are looking for efficient treatment choices, the PFO closure device market is expected to rise rapidly as awareness and technology advance.

Patent Foramen Ovale Closure Device market report

Key Insights

North America accounted for the largest share of the Patent Foramen Ovale Closure Device market at 47.20% in 2023. The market for Patent Foramen Ovale (PFO) closure devices is dominated by North America because of the region's sophisticated healthcare system, large healthcare expenditures, and rising rates of congenital cardiac disorders. With large expenditures on patient care, technology development, and medical research, the United States is a key player. Widespread acceptance is also influenced by high public knowledge of heart health issues and the advantages of less invasive procedures.

In terms of Device Type, the Amplatzer Devices accounted for a major share of 39.7%in 2023. Amplatzer devices are usually the most popular device type in the worldwide market for Patent Foramen Ovale (PFO) closure devices. Developed mostly by Abbott (via its acquisition of St. Jude Medical), these devices have long been known for their efficacy and safety, leading to their widespread use by patients and doctors.

The Amplatzer PFO Occluder has a competitive edge over substitutes like Watchman devices, Helex Septal Occluder, and other kinds because of its thorough clinical trials, FDA approval, and CE certification.

Market Dynamics

Increased awareness and diagnoses of PFO-related issues like stroke drive demand for closure devices.

The demand for Patent Foramen Ovale (PFO) closure devices is significantly influenced by growing awareness of PFO-related complications, particularly ischemic strokes and migraines. A PFO is a small hole in the heart that fails to close after birth. While it is often asymptomatic, it can allow blood clots to travel from the right to the left side of the heart and potentially reach the brain, causing a stroke. Recent medical research has highlighted the connection between PFOs and cryptogenic strokes—strokes of unknown origin—which has increased focus on identifying and managing PFOs in patients.

Advancements in diagnostic imaging and increased screening have led to higher detection rates of PFOs, especially among younger stroke patients who have no other risk factors. Physicians and cardiologists now consider PFOs a significant factor in stroke risk assessment, which in turn drives the demand for effective intervention options. PFO closure devices offer a minimally invasive solution, reducing the likelihood of recurrent strokes in specific patients and providing an alternative to lifelong blood-thinning medications. As both patients and healthcare providers become more aware of the benefits of closure procedures, the demand for these devices continues to grow, contributing to market expansion and increased usage.

The high costs of PFO closure devices and procedures limit accessibility in some markets.

The high costs associated with PFO closure devices and procedures create a significant barrier to accessibility, particularly in low- and middle-income markets. These devices are specialized medical implants that require advanced materials and stringent manufacturing processes to ensure patient safety, which drives up production costs. Moreover, the implantation procedures are complex, involving specialized cardiologists and advanced imaging technologies, further increasing overall expenses.

For healthcare systems with limited funding, especially those lacking comprehensive insurance coverage or reimbursement policies, these high costs make it difficult to adopt PFO closure as a standard treatment. As a result, patients in these regions often have to pay out of pocket, restricting access to those who can afford it. This financial barrier limits the number of eligible patients for PFO closure, despite its effectiveness in reducing stroke recurrence, thereby creating a disparity in treatment accessibility and outcomes across different socioeconomic groups.

Key Pointers

Values

Report Focus

Global

Largest Region

North America

Fastest Growing Region

Asia Pacific

Base Year

2023

CAGR % (2024-2030)

7.0%

Forecast Year

2024-2030

Historical Year

2015-2022

Market Size in 2023

USD 274.22 million

Market Size in 2030

USD 433.56 million

Countries Covered

U.S., Canada, Mexico, Germany, UK, France, Italy, Spain, Turkey, Israel, China, Japan, India, South Korea, Australia, SEA, Brazil, Chile, Argentina, Saudi Arabia, UAE, Qatar, South Africa, Rest of World

Key Driver & Challenges

Rising stroke incidence, advancements in minimally invasive procedures, and growing awareness of heart health.

High device costs, regulatory hurdles, and alternative treatments restrain market growth. 

Segments Covered

by Device Type, by Procedure Type, by End User

Segmental Analysis

Based on Device Type, Patent Foramen Ovale Closure Device market is segmented into Amplatzer Devices, Watchman Devices, Helex Septal Occluder, and Other Types. 

Patent Foramen Ovale Closure Device market size

The global patent foramen ovale (PFO) closure device market is dominated by the Amplatzer Devices segment for a number of important reasons. First off, the Amplatzer devices are well-known for their cutting-edge design and effectiveness, as well as their minimal complication profiles and high success rates in closures. A wide spectrum of patients can benefit from Amplatzer occluders due to its distinctive form and flexibility, which enable appropriate placement in a variety of anatomical situations.

Additionally, the strong clinical evidence demonstrating the efficacy and safety of Amplatzer devices boosts physician trust, which promotes greater adoption rates. The Amplatzer line's numerous device alternatives, such as the Amplatzer PFO Occluder, accommodate a range of patient requirements and preferences, hence reinforcing its market dominance.

Segments

Values

By Procedure Type
  • Transcatheter Closure
  • Surgical Closure

By End-User
  • Hospitals
  • Ambulatory Surgical Centers (ASCs)
  • Cardiology Clinics

Regional Landscape

In the context of regional analysis, the Patent Foramen Ovale Closure Device market includes North America, Europe, Asia Pacific, South America, and the Middle East and Africa.

Global Patent Foramen Ovale Closure Device market

The market size of the North America was valued at USD 128 million in 2023 and is expected to reach USD 197.27 Million by 2030, with a CAGR of 47.20% during the forecast period. The Patent Foramen Ovale (PFO) closure device market is dominated by North America, which holds a substantial market share because of a number of important factors. Innovative medical technology can be adopted in the region because of its high healthcare spending and sophisticated healthcare infrastructure. Due to increased patient and healthcare provider knowledge of the rising incidence of ischemic strokes and related disorders linked to PFOs, PFO closure treatments are becoming more common. 

Furthermore, competition and innovation are encouraged by the presence of big firms like Abbott Laboratories, Boston Scientific, and W.L. Gore & Associates, which propels the creation of new and enhanced closure devices. Strong regulatory backing and a clear approval procedure guarantee that safety and effectiveness requirements are fulfilled, which further boosts market expansion.

Patient education campaigns and professional guidelines promoting PFO closure as a viable treatment option have also contributed to increased procedural volumes. Furthermore, research and clinical trials conducted in North America provide valuable insights, enhancing the overall understanding of PFO-related risks and benefits of closure devices. These factors combined position North America as a leader in the PFO closure device market, making it a focal point for advancements in cardiac care.

 

Competitive Landscape

Some of the major companies operating within the Patent Foramen Ovale Closure Device market are: Starway,LifeTech, Occlutech,Abbott,W. L. Gore & Associates, Cardia and Others.

Table of Contents

  1. Global Patent Foramen Ovale Closure Device Market Introduction and Market Overview
    1. Objectives of the Study
    2. Global Patent Foramen Ovale Closure Device Market Scope and Market Estimation
      1. Global Patent Foramen Ovale Closure Device Overall Market Size (US$ Trillion), Market CAGR (%), Market forecast (2024 - 2034)
      2. Global Patent Foramen Ovale Closure Device Market Revenue Share (%) and Growth Rate (Y-o-Y) from 2019 - 2034
    3. Market Segmentation
      1. Device Type of Global Patent Foramen Ovale Closure Device Market
      2. Procedure Type of Global Patent Foramen Ovale Closure Device Market
      3. End-User of Global Patent Foramen Ovale Closure Device Market
      4. Region of Global Patent Foramen Ovale Closure Device Market
  2. Executive Summary
    1. Demand Side Trends
    2. Key Market Trends
    3. Market Demand (US$ Trillion) Analysis 2019 – 2023 and Forecast, 2024 – 2034
    4. Demand and Opportunity Assessment
    5. Market Dynamics
      1. Drivers
      2. Limitations
      3. Opportunities
      4. Impact Analysis of Drivers and Restraints
    6. Cost Tear Down Analysis
    7. Key Developments
    8. Porter’s Five Forces Analysis
      1. Bargaining Power of Suppliers
      2. Bargaining Power of Buyers
      3. Threat of Substitutes
      4. Threat of New Entrants
      5. Competitive Rivalry
    9. PEST Analysis
      1. Political Factors
      2. Economic Factors
      3. Social Factors
      4. Technological Factors
    10. Production Farm Size by Countries, 2019-2023, Units
    11. Production Farm Size by Companies & Locations, 2019-2023,
      1. Starway
      2. LifeTech
      3. Occlutech
      4. Abbott
      5. W. L. Gore & Associates
      6. Cardia
      7. Others
  3. Global Patent Foramen Ovale Closure Device Market Estimates & Historical Trend Analysis (2019 - 2023)
  4. Global Patent Foramen Ovale Closure Device Market Estimates & Forecast Trend Analysis, by Device Type
    1. Global Patent Foramen Ovale Closure Device Market Revenue (US$ Trillion) Estimates and Forecasts, Device Type, 2019 - 2034
      1. Amplatzer Devices
      2. Watchman Devices
      3. Helex Septal Occluder
      4. Other Types
  5. Global Patent Foramen Ovale Closure Device Market Estimates & Forecast Trend Analysis, by Procedure Type
    1. Global Patent Foramen Ovale Closure Device Market Revenue (US$ Trillion) Estimates and Forecasts, Procedure Type, 2019 - 2034
      1. Transcatheter Closure
      2. Surgical Closure
  6. Global Patent Foramen Ovale Closure Device Market Estimates & Forecast Trend Analysis, by End-User
    1. Global Patent Foramen Ovale Closure Device Market Revenue (US$ Trillion) Estimates and Forecasts, End-User, 2019 - 2034
      1. Hospitals
      2. Ambulatory Surgical Centers (ASCs)
      3. Cardiology Clinics
  7. Global Patent Foramen Ovale Closure Device Market Estimates & Forecast Trend Analysis, by Region
    1. Global Patent Foramen Ovale Closure Device Market Revenue (US$ Trillion) Estimates and Forecasts, by Region, 2019 - 2034
      1. North America
      2. Europe
      3. Asia Pacific
      4. Middle East & Africa
      5. South America
  8. North America Patent Foramen Ovale Closure Device Market: Estimates & Forecast Trend Analysis
    1. North America Patent Foramen Ovale Closure Device Market Assessments & Key Findings
      1. North America Patent Foramen Ovale Closure Device Market Introduction
      2. North America Patent Foramen Ovale Closure Device Market Size Estimates and Forecast (US$ Billion) (2019 - 2034)
        1. By Device Type
        2. By Procedure Type
        3. By End-User
        4. By Country
          1. The U.S.
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in the U.S., 2019-2023
          2. Canada
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Canada, 2019-2023
          3. Mexico
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Mexico., 2019-2023
  9. Western Europe Patent Foramen Ovale Closure Device Market: Estimates & Forecast Trend Analysis
    1. Western Europe Patent Foramen Ovale Closure Device Market Assessments & Key Findings
      1. Western Europe Patent Foramen Ovale Closure Device Market Introduction
      2. Western Europe Patent Foramen Ovale Closure Device Market Size Estimates and Forecast (US$ Billion) (2019 - 2034)
        1. By Device Type
        2. By Procedure Type
        3. By End-User
        4. By Country
          1. Germany
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Germany, 2019-2023
          2. Italy
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Italy, 2019-2023
          3. U.K.
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in U.K, 2019-2023
          4. France
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in France, 2019-2023
          5. Spain
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Spain, 2019-2023
          6. Benelux
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Benelux, 2019-2023
          7. Nordics
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Nordics, 2019-2023
          8. Rest of W. Europe
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Rest of Western Europe, 2019-2023
  10. Eastern Europe Patent Foramen Ovale Closure Device Market: Estimates & Forecast Trend Analysis
    1. Eastern Europe Patent Foramen Ovale Closure Device Market Assessments & Key Findings
      1. Eastern Europe Patent Foramen Ovale Closure Device Market Introduction
      2. Eastern Europe Patent Foramen Ovale Closure Device Market Size Estimates and Forecast (US$ Billion) (2019 - 2034)
        1. By Device Type
        2. By Procedure Type
        3. By End-User
        4. By Country
          1. Russia
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Russia, 2019-2023
          2. Hungary
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Hungary, 2019-2023
          3. Poland
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Poland, 2019-2023
          4. Balkan & Baltics
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Balkan and Baltics, 2019-2023
          5. Rest of E. Europe
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Eastern Europe, 2019-2023
  11. Asia Pacific Patent Foramen Ovale Closure Device Market: Estimates & Forecast Trend Analysis
    1. Asia Pacific Market Assessments & Key Findings
      1. Asia Pacific Patent Foramen Ovale Closure Device Market Introduction
      2. Asia Pacific Patent Foramen Ovale Closure Device Market Size Estimates and Forecast (US$ Billion) (2019 - 2034)
        1. By Device Type
        2. By Procedure Type
        3. By End-User
        4. By Country
          1. China
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in China, 2019-2023
          2. Japan
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Japan, 2019-2023
          3. India
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in India, 2019-2023
          4. Australia & New Zealand
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Australia and New Zealand, 2019-2023
          5. South Korea
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in South Korea, 2019-2023
          6. ASEAN
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in ASEAN, 2019-2023
          7. Rest of Asia Pacific
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Rest of Asia Pacific 2019-2023
  12. Middle East & Africa Patent Foramen Ovale Closure Device Market: Estimates & Forecast Trend Analysis
    1. Middle East & Africa Market Assessments & Key Findings
      1. Middle East & Africa Patent Foramen Ovale Closure Device Market Introduction
      2. Middle East & Africa Patent Foramen Ovale Closure Device Market Size Estimates and Forecast (US$ Billion) (2019 - 2034)
        1. By Device Type
        2. By Procedure Type
        3. By End-User
        4. By Country
          1. UAE
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in UAE, 2019-2023
          2. Saudi Arabia
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Saudi Arabia, 2019-2023
          3. Turkey
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Turkey, 2019-2023
          4. South Africa
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in South Africa, 2019-2023
          5. Rest of MEA
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Rest of MEA, 2019-2023
  13. Latin America Patent Foramen Ovale Closure Device Market: Estimates & Forecast Trend Analysis
    1. Latin America Market Assessments & Key Findings
      1. Latin America Patent Foramen Ovale Closure Device Market Introduction
      2. Latin America Patent Foramen Ovale Closure Device Market Size Estimates and Forecast (US$ Billion) (2019 - 2034)
        1. By Device Type
        2. By Procedure Type
        3. By End-User
        4. By Country
          1. Brazil
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Brazil, 2019-2023
          2. Argentina
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Argentina, 2019-2023
          3. Colombia
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Colombia, 2019-2023
          4. Rest of LATAM
            1. By Device Type
            2. By Procedure Type
            3. By End-User
            4. Top Companies Market Share in Rest of LATAM, 2019-2023
  14. Country Wise Patent Foramen Ovale Closure Device Market: Introduction
  15. Competition Landscape
    1. Global Patent Foramen Ovale Closure Device Market Product Mapping
    2. Global Patent Foramen Ovale Closure Device Market Concentration Analysis, by Leading Players / Innovators / Emerging Players / New Entrants
    3. Global Patent Foramen Ovale Closure Device Market Tier Structure Analysis
    4. Global Patent Foramen Ovale Closure Device Market Concentration & Company Market Shares (%) Analysis, 2023
  16. Company Profiles
    1. Starway
      1. Company Overview & Key Stats
      2. Revenue (USD Million), Sales (Units), and Gross Margin & Market Share, 2019-2023
      3. Product Portfolio & Pricing Analysis
      4. SWOT Analysis
      5. Business Strategy & Recent Developments

* Similar details would be provided for all the players mentioned below 

    1. LifeTech
    2. Occlutech
    3. Abbott
    4. W. L. Gore & Associates
    5. Cardia
    6. Others
  2. Research Methodology
    1. External Transportations / Databases
    2. Internal Proprietary Database
    3. Primary Research
    4. Secondary Research
    5. Assumptions
    6. Limitations
    7. Report FAQs
  3. Research Findings & Conclusion

No of Tables: 250
No of Figures: 200

Frequently Asked Questions

The average CAGR of Patent Foramen Ovale Closure Device Market is 7.0%.

Amplatzer Devices dominated the market with a share of 39.7% in 2023.

APAC is estimated to emerge as a fastest growing region with a CAGR of 7.8% during the forecast period 2024-2030.

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