Market Overview

GORE® Molding & Occlusion Balloon for Endovascular Aortic Repair Receives Approval in the United States, Japan, and Europe


New balloon addresses EVAR stent graft seal and temporary vessel
occlusion challenges

L. Gore & Associates, Inc.
(Gore) announced FDA 510(k)
clearance, approval from the Japanese Ministry of Health, Labour, and
Welfare, and receipt of CE Mark for the innovative GORE®
Molding & Occlusion Balloon, a compliant polyurethane balloon catheter
designed in close collaboration with clinicians to assist in the
expansion of self-expanding stent grafts or to temporarily occlude
large-diameter vessels. The new device meets all endovascular aortic
repair (EVAR) procedural requirements – a single balloon that replaces
the need for multiple molding and occlusion balloons.

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GORE® Molding & Occlusion Balloon (Photo: Business Wire)

GORE® Molding & Occlusion Balloon (Photo: Business Wire)

The device's proven radial expansion force across the range of EVAR
device sizes enables physicians to consistently seat and seal grafts
with confidence. This more efficient graft seal may reduce procedural
time and the risk of Type 1 endoleaks. The device is also engineered
with the lowest profile to reduce the potential of access-related
complications, and its excellent pushability and trackability offers
enhanced control with uncompromised inflation and deflation time.

"We have worked closely with clinicians to engineer a single balloon
that truly changes both the physician and the patient experience," said
Eric Zacharias, Gore Vascular Business Leader. "This milestone is one of
several in our ongoing dedication to treating the entire aorta, and to
helping physicians offer the best patient experience possible."

The new device is supplied in a single catheter length of 90 cm to
enable use with current GORE®
as well as future Gore devices while
still being compatible with a 180 cm length guidewire.

Besides adding value through consistently reliable technical success and
patient experience, the use of a single balloon allows for efficiency
and inventory optimization. "We know our physicians are concerned with
both technical performance and with economic value to their practices,"
Zacharias said. "Use of a single molding and occlusion balloon during an
EVAR case reduces intraoperative waste, minimizing overall instrument
cost per procedure. The potential to reduce operating room and catheter
lab time may contribute to faster room turnover and more on-time
procedural starts."

Molding & Occlusion Balloon
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 teams and
educational offerings. The comprehensive portfolio of aortic products
includes the GORE® EXCLUDER® AAA Endoprosthesis;
the Conformable GORE® TAG® Thoracic Endoprosthesis
for the treatment of thoracic aneurysms, transections, and Type B
dissections; and the GORE® EXCLUDER® Iliac Branch
Endoprosthesis, the only FDA approved off-the-shelf device indicated for
the endovascular treatment of common iliac artery aneurysms or
aortoiliac aneurysms.

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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.

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.

Products listed may not be available in all markets.
are trademarks of W. L. Gore & Associates.

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