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Gore Receives FDA Approval for the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL

May 15, 2019 Off By BusinessWire

The device and new delivery system combine proven conformability with
enhanced placement control to optimize TEVAR outcomes in even complex
aortic anatomy

FLAGSTAFF, Ariz.–(BUSINESS WIRE)–W.
L. Gore & Associates, Inc. (Gore) today announced that the U.S.
Food and Drug Administration (FDA) has granted regulatory approval for
commercial distribution for the GORE® TAG® Conformable Thoracic Stent
Graft with ACTIVE CONTROL System, a unique Thoracic Endovascular Aortic
Repair (TEVAR) solution combining new levels of control with the proven
legacy and trusted performance of the Conformable GORE® TAG® Device. The
device and delivery system provide new precision and predictable patient
outcomes in the endovascular repair of aneurysms, transections, and Type
B dissections of the descending thoracic aorta. A smaller-diameter
primary delivery sleeve gives the device and system a lower profile
across 10 device sizes.

The GORE® ACTIVE CONTROL System provides controlled, two-stage
deployment, with primary deployment to an intermediate diameter and a
secondary deployment to full diameter. This design allows for continuous
blood flow throughout the deployment with multiple opportunities to
visualize and refine graft placement. It is also designed to allow for
angulation of the proximal end of the device for improved seal and
apposition. It gives physicians added precision in placement and
angulation so they can take full advantage of the exceptional
conformability of the Gore device and confidently provide a
minimally-invasive solution to more patients.

No change was made to the stent graft itself, which, as the world’s
most-studied* TEVAR device, has demonstrated long-term freedom from
device-related reintervention (93.1%) and low complication rates (zero
migrations, fractures, or compressions).** Large device oversizing
windows were engineered, tested, and proven to accommodate differences
in proximal and distal landing zone diameters; a unique 6% to 33%
oversizing window allows physicians to choose the optimal radial force
to fit patient anatomy and etiology, whether treating a young trauma
patient or a fragile dissected aorta. The 16mm to 42mm range can be
treated with as few as five sizes, allowing providers to stock fewer
devices while treating a broader range of patients.

“The GORE® TAG® Device family has a legacy of trusted performance and
durability, and we knew we could build on that by enhancing control
during deployment, which would help make TEVAR procedures more
predictable for physicians,” said Eric Zacharias, a vascular business
leader at Gore. “Physicians can now deploy our thoracic stent graft in
the descending thoracic aorta with more operative ease, even in those
patients with challenging angulated aortic arches, and meet the clinical
and practical challenges of TEVAR with confidence. With this latest
product iteration, Gore is continuing its unparalleled commitment to
developing solutions that advance endovascular solutions for diseases of
the aorta.”

The GORE
TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
is part of the growing family of endovascular products that share a
mission to effectively treat aortic disease, backed by Gore’s highly
rated clinical support team and educational offerings. The portfolio of
products includes the GORE®
EXCLUDER® AAA Endoprosthesis for the treatment of abdominal
aortic aneurysms (AAA). The GORE®
EXCLUDER® Iliac Branch Endoprosthesis is the first FDA-approved,
off-the-shelf device for the endovascular treatment of common iliac
artery aneurysms or aortoiliac aneurysms, and is intended for use with
the GORE EXCLUDER AAA Endoprosthesis.†

* Based on company-sponsored trials and registries shown on
clinicaltrials.gov for currently available stent grafts.

** Consolidated site reported outcomes following 5 years of follow-up
in TAG 08-01, TAG 08-02, TAG 08-03 clinical studies.

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

Medical Products Division

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

Products listed may not be available in all markets.

GORE®, GORE-TEX®, ACTIVE CONTROL, EXCLUDER®, and
TAG® are trademarks of W. L. Gore & Associates.