Gore REDUCE Clinical Study Five-Year Results Demonstrate That PFO Closure With The GORE® CARDIOFORM Septal Occluder Provides Safe Long-Term Reduction Of Recurrent Stroke

Author: W. L. Gore & Associates, Inc. MPD Division / 2023-07-22 19:47 / Source: W. L. Gore & Associates, Inc. MPD Division

Gore REDUCE Clinical Study Five-Year Results Demonstrate That PFO Closure With The GORE® CARDIOFORM Septal Occluder Provides Safe Long-Term Reduction Of Recurrent Stroke

- Published in the New England Journal of Medicine (NEJM),the REDUCE Study continues to show the largest reduction in recurrent ischemic stroke in all PFO shunt sizes over medical therapy alone.*,¹

- Long-term results highlight GORE®CARDIOFORM Septal Occluder can be trusted for patient safety and effective defect closure.

FLAGSTAFF,Ariz.,March 11,2021 --W. L. Gore & Associates (Gore),today announced that Gore REDUCE Study long-term follow-up results were published in the March 2021 issue of The New England Journal of Medicine (NEJM),highlighting the benefits of patent foramen ovale (PFO) closure. The extended follow-up data further supports the use of GORE CARDIOFORM Septal Occluder in long-term recurrent stroke prevention.

The long-term data demonstrated a 69 percent relative reduction (P = .007) in ischemic stroke in patients treated with a Gore Device compared to patients treated with antiplatelet therapy alone.[1] Significantly,these data demonstrate no new device or procedure-related serious adverse events observed during the extended follow-up (median of five years) and continue to build on the GORE CARDIOFORM Septal Occluder's strong legacy of patient safety.[1,2]

The REDUCE Study evaluated whether PFO closure with a Gore Device plus antiplatelet therapy reduces the risk of stroke compared to antiplatelet therapy alone. The controlled,open-label study included 664 randomized patients at 63 investigational sites in seven countries. A total of 441 patients were treated with a Gore Device for PFO closure plus antiplatelet therapy and 223 patients were treated with antiplatelet therapy alone.

During the extended follow-up,there was only one new case of non-serious atrial fibrillation (AFib),and it resolved.[2] At a median follow-up of 3.2 years the study showed only 0.5 percent device or procedure-related serious AFib,and at a median follow-up of five years,no new serious AFib cases were reported. No new cases of AFib were associated with the device or procedure.[2]

"We are excited to publish the REDUCE Study extended follow-up. These are important data as they confirm the procedure is safe with only one new episode of atrial fibrillation and no issues related to frame fractures,thrombus,embolization or erosion. Overall,the benefit of PFO closure persisted during late follow-up by lowering the risk of recurrent stroke with minimal risk for adverse events," said John F. Rhodes,M.D.,Medical University of South Carolina,and U.S. Cardiology National Principal Investigator for the REDUCE Study.

PFOs occur after birth when the foramen ovale,an opening between the heart's upper two chambers in an unborn baby,fails to close and allows blood to flow between the two atria. PFO occurs in about one in four people.[3] While most people do not need to be treated for PFO,in some patients,stroke can occur if a blood clot travels through the opening and to the brain. About one quarter of first-time strokes are cryptogenic,or due to an unknown cause,and up to half of patients who have a cryptogenic stroke are found to have PFO.[4]

Twenty-five patients would need to be treated with a Gore Device* to prevent one recurrent stroke event over five years,demonstrating compelling real-world therapeutic value for patients treated with a GORE CARDIOFORM Septal Occluder.[1]

The GORE CARDIOFORM Septal Occluder combines unique materials and design to provide a soft and conformable device for safe and effective PFO closure. The minimal,nitinol wire frame structure,covered with ePTFE material,conforms to the adjacent,native anatomy facilitating high closure rates with rapid tissue ingrowth and stabilization. With over 45,000 devices sold globally and nine years† of clinical use,GORE CARDIOFORM Septal Occluder can be trusted for safety and performance.

"These outcomes for long-term safety and recurrent stroke reduction speak volumes to the durability,performance and effectiveness of the GORE CARDIOFORM Septal Occluder," said John Laschinger,Gore's Cardiac Chief Medical Advisor. "The unique benefit of our conformable design tailored to fit unique PFO anatomies is underscored by the fact that GORE CARDIOFORM Septal Occluder has a 99 percent effective closure rate at 24 months." ‡(data on file 2020; W. L. Gore & Associates,Inc; Flagstaff,AZ.)

The GORE CARDIOFORM Septal Occluder received U.S. Food and Drug Administration premarket approval for the percutaneous closure of PFO in 2018. It is also approved in the European Union for percutaneous closure of PFO. Furthermore,it is approved in the United States and European Union for closure of a type of atrial septal defect.§

* The REDUCE Study determined safety and efficacy of PFO closure with the GORECARDIOFORM Septal Occluder or GORE®HELEX®Septal Occluder plus antiplatelet medical management compared to antiplatelet medical management alone in patients with a PFO and history of cryptogenic stroke. All PFO anatomies were incorporated into this study within indicated sizing parameters of the Instructions for Use.

†Beginning in June 2011.

‡Effective closure defined as freedom from large shunt > 25 bubbles as detected by transthoracic echocardiography adjudicated by Echo Core Lab.

§For complete indications and other important safety information for Gore commercial products referenced herein,refer to the applicable Instructions for Use (IFU).

Kasner SE,Rhodes JF,Andersen G; Gore REDUCE Clinical Study Investigators. Five-year outcomes of PFO closure or antiplatelet therapy for cryptogenic stroke. New England Journal of Medicine 2021;384(10):970-971.

Sondergaard L,Kasner SE,et al.; Gore REDUCE Study Investigators. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. New England Journal of Medicine 2017;377(11):1033-1042.

Koutroulou I,Tsivgoulis G,Tsalikakis D,Karacostas D,Grigoriadis N,Karapanayiotides T. Epidemiology of patent foramen ovale in general population and in stroke patients: a narrative review. Frontiers in Neurology 2020;11:281.

Thaler DE,Ruthazer R,Di Angelantonio E,et al. Neuroimaging findings in cryptogenic stroke patients with and without patent foramen ovale.Stroke 2013;44(3):675-680.

Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 50 million medical devices implanted over the course of more than 45 years,Gore builds on its legacy of improving patient outcomes through research,education and quality initiatives. Product performance,ease of use and quality of service provide sustainable cost savings for physicians,hospitals and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives. goremedical.com

About Gore

W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958,Gore has solved complex technical challenges in demanding environments — from outer space to the world's highest peaks to the inner workings of the human body. With more than 11,000 Associates and a strong,team-oriented culture,Gore generates annual revenues of $3.8 billion. gore.com

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Gore REDUCE Clinical Study Five-Year Results Demonstrate That PFO Closure With The GORE® CARDIOFORM Septal Occluder Provides Safe Long-Term Reduction Of Recurrent Stroke

GORE® CARDIOFORM Septal Occluder

Gore REDUCE Clinical Study Five-Year Results Demonstrate That PFO Closure With The GORE® CARDIOFORM Septal Occluder Provides Safe Long-Term Reduction Of Recurrent Stroke