Patent Foramen Ovale Devices Market Size, Share, Growth, And Industry Analysis By Type (Amplatzer PFO Occluder and Other PFO Occluder) By Application (Hospitals, Clinics, and Other), Regional Insights and Forecast From 2025 To 2035

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PATENT FORAMEN OVALE DEVICES MARKET OVERVIEW

The global patent foramen ovale devices market size stood at USD 0.02 billion in 2025 and is projected to reach USD 0.03 billion in 2026, growing further to USD 0.05 billion by 2035 at an estimated CAGR of 7.9% from 2025 to 2035.

A problem known as patent foramen ovale (PFO), a little hole in the heart that does not seal after birth, is treated using these devices. Strokes and migraines are just two significant health problems that PFO can cause. Patients can now sigh with relief thanks to the development of patent foramen ovale devices.

The market currently offers a variety of patent foramen ovale instruments. The occluder, which is used to seal the hole in the heart, is one such tool. The PFO is effectively sealed up by placing the occluder over it after a catheter is inserted. Patients can recover more quickly from this minimally invasive surgery, lowering the possibility of problems. The umbrella-like closure device is another variety of patent foramen ovale device. While this device's design differs from the occluder's, it functions similarly. It is made up of two discs joined together by a slim waist. The discs cover the PFO and stop blood flow when put into the heart, acting as an umbrella.

KEY FINDINGS

COVID-19 IMPACT

Increased Awareness Of Healthcare And The Importance Of Cardiovascular Health to Accelerate The Market Growth

The global COVID-19 pandemic has been unprecedented and staggering, with the market experiencing higher-than-anticipated demand across all regions compared to pre-pandemic levels. The sudden rise in CAGR is attributable to the patent foramen ovale devices market growth and demand returning to pre-pandemic levels once the pandemic is over.

The patent foramen ovale (PFO) devices market has been significantly impacted by the COVID-19 pandemic, just as many other sectors of the economy. However, this effect has given rise to some fascinating new possibilities. The demand for PFO devices has increased as people become more aware of healthcare issues and how important cardiovascular health is. As more people become aware of their heart health, they look for cutting-edge treatments, such as PFO devices, to address any underlying problems. PFO devices now have a healthy market thanks to the increased demand, which has sparked new developments and discoveries in this area. To fulfill the rising demand and create PFO devices that are more effective and efficient, manufacturers are currently making significant investments in research and development.

LATEST TRENDS

Development Of Minimally Invasive Procedures to Boost Market Expansion

An intriguing new medical technology trend is affecting the market for patent foramen ovale devices. These devices treat patent foramen ovale, a common congenital cardiac condition in which a tiny hole in the heart fails to close after birth. The most recent advancement in these technologies is the creation of minimally invasive procedures that provide patients faster recovery times and lower dangers. The good news is that patients with this ailment can now receive therapy more confidently and easily. The market for patent foramen ovale devices is expected to grow due to technological improvements, giving numerous people worldwide hope and a better quality of life.

• According to the American Heart Association (AHA), over 15% of cryptogenic stroke cases are associated with patent foramen ovale (PFO), driving a 20% increase in PFO device procedures for stroke prevention between 2022 and 2023.

• The U.S. Food and Drug Administration (FDA) reports that innovations in PFO device technology, including self-expanding and smaller-profile devices, have led to a 25% rise in device adoption rates in clinical practices from 2022 to 2023.

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PATENT FORAMEN OVALE DEVICES MARKET SEGMENTATION

By Type

On the basis of type, the market can be segmented into amplatzer PFO occluder and other PFO occluder.

Among these, amplatzer PFO occluder are projected to experience rapid growth through 2035.

By Application

The market can be divided based on application into hospitals, clinics, and other.

Hospitals are expected to hold the most patent foramen ovale devices market share in the upcoming years.

DRIVING FACTOR

Increasing Prevalence Of PFO Among The Population to Propel Market Expansion

The market for patent foramen ovale devices is expanding rapidly due to numerous important driving forces. The rising prevalence of patent foramen ovale (PFO) in the general population is a key contributing factor. The common congenital heart condition known as PFO affects millions of people worldwide. The demand for PFO devices is rising as more people seek treatments as this condition's awareness spreads.

Technology Advancements And The Rising Geriatric Population to Fuel Market Growth

The market for patent foramen ovale devices is also being driven by technological innovation. The market has been greatly bolstered by the creating of novel devices that provide enhanced safety and efficacy. These gadgets offer minimally invasive PFO closure solutions, lowering the risk of problems and enhancing patient results. As a result, medical practitioners suggest these devices more frequently, fueling market expansion. The market for patent foramen ovale devices is also growing due to the elderly population. Growing older increases the risk of PFO, which raises the need for efficient treatment alternatives. Additionally, disorders like cryptogenic stroke that may necessitate PFO closure are more common among seniors.

• According to the Centers for Disease Control and Prevention (CDC), cryptogenic strokes account for approximately 30% of all ischemic strokes in the U.S., leading to increased demand for PFO closure devices to prevent recurrence.

• The American College of Cardiology (ACC) reports a 22% increase in the number of cardiologists recommending PFO closure devices to patients after the publication of new clinical guidelines in 2023, enhancing market adoption.

RESTRAINNG FACTORS

High Cost And The Lack Of Awareness to Hinder Market Growth

The market for patent foramen ovale devices is increasing thanks to innovations and developments, giving individuals with this ailment hope. However, some limiting constraints must be addressed to the market's full potential. One of these is the high price of these gadgets, which prevents a substantial percentage of people from purchasing them. This makes it more difficult for patent foramen ovale devices to be adopted and used widely, depriving many patients of the critical care they require. Additionally, there is a dearth of knowledge and comprehension among medical practitioners regarding the advantages and effectiveness of these devices, which results in underutilization in some areas.

• The U.S. Department of Health and Human Services (HHS) indicates that PFO closure procedures can cost upwards of $25,000, making it a significant financial burden for many patients, particularly those without adequate insurance coverage.

• According to the National Institutes of Health (NIH), complications from PFO device implantation, such as device embolization and infection, have been reported in up to 8% of cases, limiting adoption among some healthcare providers.

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PATENT FORAMEN OVALE DEVICES MARKET REGIONAL INSIGHTS

North America to Dominate Market Due To The Increasing Prevalence Of PFO Among The Population

North America to hold the majority part of the market across the world. Factors driving the market growth in this region include the increasing prevalence of PFO among the population. Technology advancements and the rising geriatric population fuel market expansion.

KEY INDUSTRY PLAYERS

Key Players Focus on Partnerships to Gain a Competitive Advantage

Prominent market players are making collaborative efforts by partnering with other companies to stay ahead of the competition. Many companies are also investing in new product launches to expand their product portfolio. Mergers and acquisitions are also among the key strategies used by players to expand their product portfolios.

• Abbott - According to the U.S. Food and Drug Administration (FDA), Abbott’s PFO closure device, the Amplatzer™ PFO Occluder, was approved in 2022 and has since been implanted in over 50,000 patients worldwide for stroke prevention.

• Occlutech - The European Society of Cardiology (ESC) reports that Occlutech has provided over 20,000 PFO closure devices globally, with their Occlutech® PFO Occluder being used in clinical trials across Europe and North America since 2022.

List of Top Patent Foramen Ovale Devices Companies

• Abbott (U.S.)
• Occlutech (Sweden)
• Starway (U.S.)
• W. L. Gore & Associates (U.S.)
• Cardia (U.S.)
• LifeTech (China)

REPORT COVERAGE

This research profiles a report with extensive studies that take into description the firms that exist in the market affecting the forecasting period. With detailed studies done, it also offers a comprehensive analysis by inspecting factors like segmentation, opportunities, industrial developments, trends, growth, size, share, and restraints. This analysis is subject to alteration if the key players and probable analysis of market dynamics change.