FLAGSTAFF, Ariz., June 4, 2019 /PRNewswire/ -- W. L. Gore
& Associates (Gore) announced the U.S. Food and Drug
Administration's (FDA's) premarket approval (PMA) of the GORE®
CARDIOFORM ASD Occluder for the percutaneous closure of ostium
secundum atrial septal defects (ASDs). The FDA approval was
supported by data collected from the pivotal stage of the Gore
ASSURED Clinical Study which demonstrated 100 percent closure
success at the six month evaluation in patients with a successful
implant.
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The pivotal study evaluated the safety and efficacy of ASD
closure using the GORE CARDIOFORM ASD Occluder in 125 patients with
evidence of right heart volume overload demonstrating the need for
defect closure. The study involved patients between the ages of 2
and 84, across 22 investigation sites, including 15 children's
hospitals. The pivotal study met its safety, closure, and technical
success primary endpoints.
"The FDA approval of the GORE CARDIOFORM ASD Occluder is a
significant milestone for innovation in the minimally invasive
treatment of ASDs," said Matthew J.
Gillespie, M.D., Children's Hospital of Philadelphia, co-principal investigator of the
ASSURED Study. "This soft, conformable device was not previously
available for this range of defects but is now an option for larger
defects that typically have a greater risk for complications,
including right heart enlargement, atrial fibrillation, and
pulmonary hypertension. The ability to retrieve and reposition the
GORE CARDIOFORM ASD Occluder helps me ensure proper positioning and
offers me confident closure."
The GORE CARDIOFORM ASD Occluder's anatomically adaptable waist
conforms to the defect to close ASDs from 8 mm to 35 mm in
diameter, including those without a retro-aortic rim, by
facilitating optimal tissue ingrowth, while maintaining
thromboresistance. As the latest extension to the GORE CARDIOFORM
Occluder family, it builds on a legacy of safety outcomes.
"We developed the GORE CARDIOFORM ASD Occluder in partnership
with leading interventional cardiologists around the globe, and its
design is informed by decades of experience in technological
innovation and dedication to improving patient care," said
Jake Goble, M.B.A., Ph.D., Gore
Structural Heart Pipeline Leader. "This new addition extends what
physicians can achieve with the GORE CARDIOFORM Occluder
family."
In addition to the GORE CARDIOFORM ASD Occluder, the occluder
portfolio also includes the GORE® CARDIOFORM Septal Occluder
which is indicated for ASD closure for defects up to 17 mm and
received U.S. Food and Drug Administration approval in 2018 for
patent foramen ovale (PFO) closure to prevent recurrent ischemic
stroke. The FDA approval for the GORE CARDIOFORM Septal Occluder
was supported by positive results announced in May 2018 from the Gore REDUCE Clinical
Study, which demonstrated the safety and efficacy of PFO
closure with a Gore device plus antiplatelet therapy compared to
antiplatelet therapy alone in patients with a PFO and history of
cryptogenic stroke.
*For complete indications and other important safety
information for Gore commercial products referenced herein, refer
to the applicable Instructions for Use (IFU).
MEDICAL PRODUCTS DIVISIONS
Gore 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. www.goremedical.com
ABOUT GORE
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 global recognition from the Great Place to Work®
Institute. Headquartered in Newark,
Del., Gore employs 9,500 Associates and generates annual
revenues of $3.5 billion.
www.gore.com
Contact Information
Bliss Integrated Communication for
Gore Medical
Liz DeForest, 212-584-5477
Liz@blissintegrated.com
Products listed may not be available in all markets.
GORE®, GORE-TEX®, and CARDIOFORM are trademarks of W. L. Gore
& Associates
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SOURCE W. L. Gore & Associates