PR88461

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

FLAGSTAFF, Ariz., March 11, 2021 /PRNewswire=KYODO JBN/ --

  -- 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(R)CARDIOFORM Septal Occluder can be

     trusted for patient safety and effective defect closure.

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) (

https://c212.net/c/link/?t=0&l=en&o=3093735-1&h=2575644380&u=https%3A%2F%2Fwww.nejm.org%2Fdoi%2Ffull%2F10.1056%2FNEJMc2033779%3Fquery%3Dfeatured_secondary&a=The+New+England+Journal+of+Medicine+(NEJM)%2C

), 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.

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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, M.D., 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 GORE

CARDIOFORM Septal Occluder or GORE(R)HELEX(R)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).

  1. 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.

  2. Sondergaard L, Kasner SE, Rhodes JF, 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.

  3. 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.

  4. 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

Products listed may not be available in all markets.

GORE, Together, improving life, CARDIOFORM and HELEX are trademarks of W. L.

Gore & Associates.

2149161-EN  MARCH 2021

SOURCE: W. L. Gore & Associates, Inc. MPD Division

CONTACT: Lisa Henry, W. L. Gore & Associates, +1 480 338 4540,

lihenry@wlgore.com