▷ GORE® CARDIOFORM Septal Occluder has been improving people’s lives for 10 years

20.01.2022 – 03:15

W. L. Gore & Associates

Flagstaff, Arizona (ots/PRNewswire)

After a decade of clinical use* and more than 50,000 systems sold worldwide, the GORE® CARDIOFORM Septal Occluder continues the proven tradition of safely advancing care.

WL Gore & Associates (Gore) announced today that the GORE® CARDIOFORM Septal Occluder has been in clinical use for 10 years, treating patients in clinical trials and commercially for approved indications worldwide.*,† With more than 50,000 systems sold and zero reported cardiac erosions‡ (Data on file; July 2011 – November 2021; WL Gore & Associates, Inc.), this innovative technology from Gore offers physicians a safer option for treating patients with atrial septal defects (ASD) and patent foramen ovale (PFO).

The system is supported by Gore REDUCE, a landmark clinical study involving 664 patients that evaluated whether PFO closure with the GORE CARDIOFORM Septal Occluder or the GORE® HELEX® Septal Occluder plus Antiplatelet Reduced the risk of stroke compared to platelet aggregation inhibitor therapy alone. The REDUCE study is the only US investigational device exemption (IDE) study to meet its primary endpoint of a five-year significant reduction in recurrent ischemic stroke in all PFO anatomies compared to medical therapy alone showed. The study also demonstrates the safety of Gore.§,1,2 At a median follow-up of 3.2 years, the study demonstrated only 0.5 percent systemic or procedural severe atrial fibrillation (AFib), and at a median follow-up of five years, were no new severe AFib cases were reported.§,1,2 No new cases of atrial fibrillation were associated with the system or procedure.§,2 Additionally, the extended follow-up did not identify any issues related to frame fractures, thrombosis, embolism, or Erosion detected.§,1,2

Now, after 10 years of clinical use, with zero reported cases of cardiac erosion†,‡ and clinical data published in more than 250 publicationsII, the GORE CARDIOFORM Septal Occluder has continued to demonstrate its well-established safety profile and exceptional clinical performance.

“The effectiveness and longevity of the GORE CARDIOFORM Septal Occluder demonstrates Gore’s ongoing commitment to helping patients,” said Jens Erik Nielsen-Kudsk, Clinical Professor of Cardiology at Aarhus University Hospital in Denmark, Investigator for the Gore REDUCE clinical study and advisor to Gore, “Gore engineers worked closely with medical professionals to understand what patients needed and designed a system that conformed to an individual’s anatomy.”

“This important milestone demonstrates that the GORE CARDIOFORM Septal Occluder is helping to fill a recognized unmet need. Time and time again, we see healthcare organizations around the world trusting this device and choosing it for their patients,” said Jake Goble, Innovation Leader, Medical Products Division at Gore improving the lives of patients. We remain excited about future opportunities to expand the reach of this technology to benefit underserved patient populations.”

The GORE CARDIOFORM Septal Occluder is a permanently implanted system approved in the United States and European Union for the percutaneous, transcatheteric closure of atrial septal defects up to 17 mm. The device received provisional marketing approval from the U.S. Food and Drug Administration in 2018 for percutaneous closure of PFO. It is also approved in the European Union for the percutaneous closure of a PFO.† For more information on the GORE CARDIOFORM Septal Occluder, visit https://www.goremedical.com/products/cardioform/septal-occluder.

* As of June 2011.

† For complete indications and other important safety information regarding the Gore products referenced herein, please refer to their respective instructions for use (IFU).

‡ Reported incidence rate of systemic cardiac erosions for GORE CARDIOFORM Septal Occluder and GORE CARDIOFORM ASD Occluder. Data from the CATSWeb Product Surveillance Tracking System (PSTS).

§ The REDUCE study evaluated the safety and efficacy of PFO closure with the GORE CARDIOFORM Septal Occluder or GORE HELEX Septal Occluder plus antiplatelet versus antiplatelet alone in patients with PFO and a history of cryptogenic stroke. All PFO anatomy were designed within the specified size parameters of the Instructions for use included in this study.

II WL Gore & Associates, Inc. GORE CARDIOFORM Septal Occluder Complete Bibliography. Flagstaff, AZ: WL Gore & Associates, Inc .; 2020. [Bibliographie].

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

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

Gore develops medical devices that treat a variety of cardiovascular and other health conditions. With more than 50 million medical devices implanted over more than 45 years, Gore builds on its heritage of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service ensure sustainable cost savings for doctors, hospitals and health insurers. Gore works with clinicians, and through that collaboration, we improve lives.

Information about Gore

WL Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has been solving complex engineering 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 employees and a strong, team-oriented culture, Gore generates $3.8 billion in annual sales. For more information, see gore.com.

Products listed may not be available in all markets.

GORE, Together, improving life, CARDIOFORM and HELEX are trademarks of WL Gore & Associates.

21384814-THE JANUARY 2022

[email protected]

Press contact:

Lisa Henry
W. L. Gore & Associates
+1 480 338 4540
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Original content by: WL Gore & Associates, transmitted by news aktuell


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