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.
Progress starts with one conversation
From a payer perspective, the annual cost for PFO-associated strokes in the U.S. was estimated at $300 million, with hospitalization comprising 45%, followed by prescriptions and outpatient care at 19% and 16%, respectively.1
Progress starts with one diagnosis
A study model showed screening approximately 4 patients identified 1 PFO for closure, and 7 screenings prevented 1 recurrent stroke, demonstrating strong clinical efficiency.2
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. RXOnly
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.