Gore Marks Two-Year Primary Endpoint Follow-up Milestone in Study of GORE® CARDIOFORM Septal Occluder for Patent Foramen Ovale (PFO) Closure

Completion of follow -up paves way for REDUCE Clinical Study data submission to FDA for PFO indication

FLAGSTAFF, Ariz. –March 30, 2017 –W. L. Gore & Associates (Gore) has completed two-year primary endpoint follow-up for patients enrolled in its REDUCE Clinical Study assessing closure of patent foramen ovale (PFO) for the reduction of recurrent ischemic stroke. This marks a milestone for the study that will allow Gore to analyze and submit study data to the FDA for a PFO indication for the GORE® CARDIOFORM Septal Occluder.

In addition to the REDUCE Clinical Study’s primary endpoint of reduction of recurrent stroke, the study has a co-primary endpoint of reduction of new brain infarcts, inclusive of silent brain infarcts (SBI), through PFO closure. This marks the first time a study will assess the relationship between PFO closure and brain infarction reduction. Furthermore, if the study demonstrates that PFO closure with the GORE CARDIOFORM Septal Occluder reduces the occurrence of SBI, it could further support the benefits of PFO closure for the reduction of neurological events when utilized in an appropriate patient population.

“The definition of stroke has evolved beyond the presence of clinical symptoms to include a tissue-based objective imaging assessment of cerebral infarction. The inclusion of these data will provide more complete information on the ability of PFO closure to reduce recurrent embolic stroke events,” said Scott Kasner, MD, Neurologist, Philadelphia, Pennsylvania, the U.S. National Principal Investigator for the REDUCE Clinical Study.

Gore REDUCE Clinical Study

Most people with a PFO — a hole occurring in the upper wall between the left and right atria of the heart — do not experience any issues when blood flows from one atrium to the other; however, serious problems such as stoke can arise when clotted blood passes from the right to left atria through a PFO to the brain. The REDUCE Clinical Study is on track to provide data  that will address the question of whether PFO closure with the GORE CARDIOFORM Septal Occluder plus antiplatelet medical management is a safe and effective means to reducing the risk of recurrent stroke or new brain infarct when compared to antiplatelet medical management alone. The study examined 664 randomized subjects across 63 investigational sites in 7 countries.

GORE  CARDIOFORM Septal Occluder

The GORE CARDIOFORM Septal Occluder is currently approved for closure of atrial septal defects (ASDs), and is under investigation for the closure of PFOs. It is designed with two independent discs that span and cover the anatomy. The minimal wire frame of the device provides optimal apposition to the anatomy and is covered in thromboresistant ePTFE material, allowing tissue ingrowth for short-and long-term performance.

For more information, visit goremedical.com/cardioform

ABOUT W. L. GORE & ASSOCIATES

W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Founded in 1958, Gore has built a reputation for solving complex technical challenges in the most demanding environments — from revolutionizing the outerwear industry with GORE-TEX® fabric to creating medical devices that improve and save lives to enabling new levels of performance in the aerospace, pharmaceutical and mobile electronics markets, among other industries. The company is also known for its strong, team-oriented culture and continued recognition from the Great Place to Work® Institute. Headquartered in Newark, Del., Gore employs approximately 10,000 Associates and generates annual revenues that exceed $3 billion.

MEDICAL PRODUCTS DIVISION

Gore Medical Products Division engineers devices that treat a range of cardiovascular and other health conditions. With more than 40 million medical devices implanted over the course of more than 40 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.

Products listed may not be available in all markets.

GORE®, GORE-TEX®, and VIATORR® are trademarks of W. L. Gore & Associates.

 

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