Progress starts with ONE PATIENT

One patient. One choice. One positive impact.

A series of publications highlight the clinical and economic impacts of how choices around patent foramen ovale (PFO) diagnosis and treatment may add up over time.

Economic Burden of PFOs

The annual economic burden of patent foramen ovale-associated stroke in the United States.¹

John J. Volpi,^a Scott E. Kasner,^b Jet Neervoort,^c Lambertus F. Wolters,^c Timon Louwsma,^c,dAnne K. Marti^e and Erik J. Landaas^e

/Current Challenge

Patent foramen ovale (PFO) associated stroke management consists of treatment with medication with or without transcatheter closure with an implantable medical device, but there is uncertainty about which approach is cost-effective and offers value. This study addresses that uncertainty by evaluating the economic and clinical outcomes of the leading PFO closure devices compared to medical therapy alone, helping inform smarter, more cost-effective health care decisions.

$56.5 BILLION

In the U.S., the economic burden of stroke between 2018 and 2019 was estimated at $56.5 billion, corresponding to 0.26% of the gross domestic product in that year.

25%–40%

of ischemic strokes are classified as cryptogenic, with PFO as a potential underlying cause

44,000–71,000

new and recurrent PFO-associated strokes occur annually

Up to 2,900

PFO-associated strokes are fatal

/Study Results^f

The total direct and indirect costs of PFO-associated strokes in the U.S. were estimated at $1.3 billion annually, with $1.0 billion from new strokes and $305 million from recurrent strokes.

Societal total annual direct and indirect costs

$1.3+ Billion

Payer total annual direct medical costs

$302 Million

/Conclusions

Discover the impact of PFO treatment and diagnosis.

By changing the way we look at PFO screening, diagnosis and treatment, we have the opportunity to reduce PFO-associated stroke costs and improve patient outcomes.

Discover the potential impact of PFO diagnosis and treatment.

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Discover the impact of PFO diagnosis and treatment

Progress starts with one conversation

From a payer perspective, the annual cost for PFO-associated strokes in the U.S. was estimated at over $300 million, with hospitalization comprising 44%, followed by prescriptions and outpatient care at 19% and 16%, respectively.¹

The challenges of patent foramen ovale (PFO) and cryptogenic stroke have an identifiable solution

The economic analysis of PFO-associated strokes in the U.S. revealed an estimated cost of over $1.3 billion, with $1 billion from new strokes and $305 million from recurrent strokes¹. However, by changing the way we look at PFO screening, diagnosis and treatment, we have the opportunity to reduce PFO-associated cost and improve patient outcomes.

In a study looking at an increased diagnostic testing scenario, in which 1000 patients were tested compared to 540 in the current testing scenario, increasing diagnostic rates from 54% to 100% was estimated to prevent 63 recurrent strokes, resulting in 23 life years saved over a life-time horizon. Savings of up to $1.9 million were realized from patients who were diagnosed and went on for closure.²

^a The Houston Methodist Institute for Academic Medicine, Houston, TX, USA.
^b Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.
^c Asc Academics B.V, Groningen, Netherlands.
^d Department of Health Sciences, University Medical Center Groningen, Groningen, Netherlands.
^e W. L. Gore & Associates, Newark, DE, USA.
^f The data presented utilized a top-down, prevalence-based approach. This estimate applies national stroke incidence and cost data to calculate the annual economic burden of PFO-associated stroke. The societal perspective includes both direct and indirect medical costs. The payer perspective focused solely on direct health care costs.

References

Volpi JJ, Kasner SE, Neervoort J, et al. The annual economic burden of patent foramen ovale-associated stroke in the United States. Journal of Stroke & Cerebrovascular Diseases: The Official Journal of National Stroke Association 2025;34(6):108319.
Volpi JJ, Kasner SE, Looman T, et al. Projected clinical and economic benefits of improved patent foramen ovale testing among cryptogenic stroke patients in the United States. Journal of Medical Economics 2025;28(1):1137-1150.

This analysis is intended to provide health care decision-makers with exploratory information on potential economic and health outcomes. It is not a substitute for clinical judgment and does not establish comparative clinical superiority or cost-effectiveness in all settings. Refer to the full publication for complete details on methodology and limitations. Institutions should consult their formulary or payer representatives for guidance on local applicability.

Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. R_XOnly

INDICATIONS FOR USE IN THE U.S.: The GORE^® CARDIOFORM Septal Occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of the following defects of the atrial septum: ostium secundum atrial septal defects (ASDs); patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.

CONTRAINDICATIONS: The GORE^® CARDIOFORM Septal Occluder is contraindicated for use in patients: unable to take antiplatelet or anticoagulant medications such as aspirin, heparin or warfarin; with anatomy where the GORE^® CARDIOFORM Septal Occluder size or position would interfere with other intracardiac or intravascular structures, such as cardiac valves or pulmonary veins; with active endocarditis, or other infections producing bacteremia, or patients with known sepsis within one month of planned implantation, or any other infection that cannot be treated successfully prior to device placement; with known intracardiac thrombi.