Market Overview

Gore Announces Successful Patient Implant of Endovascular Stent Graft for the Ascending Aorta

Share:

GORE® Ascending Stent Graft, an
investigational device, is an off-the-shelf endovascular solution
designed to treat life-threatening Type A dissections of the ascending
aorta

W.
L. Gore & Associates, Inc.
(Gore) today announced the first
implant in conjunction with the Gore ARISE Study of the GORE®
Ascending Stent Graft, an investigational device and the only
endovascular stent graft specifically designed to treat Type A
dissections of the ascending aorta. The successful procedure took place
on August 14, 2018 at Memorial Hermann Medical Center in Houston, Texas
by Anthony Estrera, MD, and Bruce Tjaden, MD, as part of the Gore ARISE
Study.

This press release features multimedia. View the full release here:
https://www.businesswire.com/news/home/20180827005089/en/

GORE® Ascending Stent Graft CAUTION: Investigational use only. Limited by United States Law to Inves ...

GORE® Ascending Stent Graft CAUTION: Investigational use only. Limited by United States Law to Investigational Use. (Photo: Business Wire)

ARISE is the first multicenter, early feasibility study approved by the
U.S. Food and Drug Administration (FDA) to investigate the use of a
minimally invasive device to treat Type A dissection. The National
Principal Investigator is Michael Reardon, MD, from Houston Methodist
Hospital. The study initially investigated the use of the GORE®
TAG® Thoracic Branch Endoprosthesis (Aortic Extender) in Type
A dissection, which is also being evaluated in its own pivotal study to
assess safety and effectiveness in treating lesions of the aortic arch
and descending thoracic aorta. The new purpose-built GORE Ascending
Stent Graft will be used for the remainder of the study to allow
investigators to gain a better understanding of how new technology can
advance treatment options for this condition.

The GORE Ascending Stent Graft features a precise delivery system that
is designed to allow for accurate, controlled deployment in complex
anatomies. The delivery system features unique angulation control that
gives physicians the option to angulate the device to achieve orthogonal
placement to the ascending aorta.

Type A aortic dissection is a tear in the lining of the ascending aorta,
above the heart, that creates a second channel of blood flow. It is an
emergent condition that requires immediate surgery upon diagnosis. The
current standard of care for these patients is open surgery involving a
sternotomy— cracking the chest and spreading the two halves of the rib
cage apart to gain access to the heart and ascending aorta. This is a
very invasive and involved surgery that includes temporarily stopping
the heart to prevent blood flow during the surgical repair.

"There is a great need for a less-invasive treatment option for Type A
dissections, which are fatal for nearly half of all sufferers within 48
hours of onset," Dr. Anthony Estrera said. "I'm excited that Gore
is breaking ground in this area with the development of the first
endovascular device specifically designed to meet the anatomical,
curvature, and deployment precision requirements unique to the ascending
aorta. This device, upon approval, could provide a treatment option for
Type A dissection patients who aren't suitable for open surgery and a
less-invasive treatment for all patients with this condition."

Not all patients with Type A aortic dissection are suitable for open
surgery. The average sufferer of ascending aortic dissention is male and
in his early 60s, although it can also affect females and a wide age
range and age groups. Risk factors that may complicate open surgery
include previous thoracic surgical repair, visceral malperfusion,
neurologic deficit, presentation with a concurrent myocardial
infarction, cardiac tamponade, obesity, advanced aged, and poor renal,
cardiac, or pulmonary function. The Gore study will investigate how an
endovascular stent graft, delivered via catheter, may be used to line
the dissected portion of the ascending aorta as a less-invasive
alternative to open surgical repair. Similar endovascular therapies have
proven to reduce the risk of complications and recovery times.

"This device is a major milestone for our growing portfolio of
endovascular aortic devices," said Eric Zacharias, Vascular Business
Leader at Gore. "The development and clinical testing of this device are
part of Gore's ongoing mission to provide our physician partners with
devices that solve unmet clinical needs that provide treatment options
to their patients. The GORE Ascending Stent Graft is a device
constructed specifically for the ascending aorta. We're excited to
continue the clinical development of this device and see the future
results of this early feasibility study."

When approved, the GORE Ascending Stent Graft will be part of the
growing family of aortic devices that share a mission to effectively
treat aortic disease, backed by Gore's highly rated clinical support
team and educational offerings. The comprehensive portfolio
of products includes the Conformable GORE® TAG®
Thoracic Endoprosthesis for the treatment of thoracic aneurysms,
transections, and Type B dissections; the market-leading GORE®
EXCLUDER® AAA Endoprosthesis for the treatment of abdominal
aortic aneurysms (AAA); and the GORE® EXCLUDER®
Iliac Branch Endoprosthesis (IBE), the first FDA approved off-the-shelf
device indicated for the endovascular treatment of common iliac artery
aneurysms or aortoiliac aneurysms.

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®, EXCLUDER®,
and TAG
® are trademarks of W. L. Gore & Associates.

View Comments and Join the Discussion!