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

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.

Contacts

Bliss Integrated Communication for Gore Medical

Liz DeForest,

212-584-5477