FLAGSTAFF, Ariz. & NEW YORK–(BUSINESS WIRE)–W. L. Gore & Associates, Inc. (Gore) announced that it
has received approval from the US Food and Drug Administration (FDA) to market
the Conformable GORE® TAG® Thoracic Endoprosthesis as a
minimally invasive treatment for patients suffering from thoracic aortic aneurysms
(TAAs). Todays announcement came at the VEITH Symposium 2011 Conference in New York. The device is the only FDA
approved ePTFE thoracic endoprosthesis designed for endovascular repair of the
descending thoracic aorta that offers conformability and ease of use, while accommodating
tapered anatomy and resisting compression. The broad oversizing window for the
device ranges from 6-33%, allowing physicians to choose the appropriate
oversizing for the patient anatomy.
William Jordan, MD, Chief of Vascular Surgery at the University of Alabama,
Birmingham,
served as national principal investigator for the Conformable GORE TAG Device
in the Thoracic Aortic Aneurysm Trial (Gore TAG 08-03) over the past two years.
According to Dr. Jordan,
“This new device represents a substantial product improvement brought to us by
a company that was already leading the market in aneurysm devices. Gore
evaluated the real world results of the first generation endograft and
engineered improvements so that the device can be used across a wider range of
aortic diameters with stronger radial force to resist compression. These
modifications are intended to improve the lives of our patients and provide
better outcomes for challenging clinical problems.”
The following physicians completed successful procedures
using the Conformable GORE TAG Thoracic Endoprosthesis during the first week of
release:
- William McMillan, MD – Vascular Surgeon at Minneapolis Vascular Physicians
- Robert Mitchell, MD – Thoracic Surgeon at Central Baptist
Hospital, Lexington, Kentucky - Brian Peterson, MD – Vascular Surgeon in the Department of
Surgery at Saint Louis
University - Robert Rhee, MD – Associate Professor of Surgery at the
University of Pittsburgh
Medical Center - Joshua Rovin, MD – Cardiovascular Surgeon at Bayfront Medical
Center, St.
Petersburg, Florida - Daniel Watson, MD – Director of Endovascular Surgery at Riverside Methodist
Hospital, Columbus, Ohio
The device is available in diameters of 21-45 mm, allowing
for the treatment of patients with aortic diameters of 16-42 mm. Tapered device
configurations are also available.
TAAs are a serious health risk because they can burst or
rupture with little or no symptoms after developing over years. A ruptured
aneurysm can cause severe internal bleeding, which can rapidly lead to shock or
death. Thoracic aneurysms affect approximately 15,000 people in the US each year.
Some patients may have more than one TAA or may also have an aneurysm of the
abdominal aorta. Due to the high mortality risk associated with undetected and
untreated TAAs, it is critical to get screened for aneurysm risk and seek early
treatment if detected.
“The GORE TAG Device has been a leading endovascular
treatment option for safely and effectively treating patients with aneurysms of
the descending thoracic aorta. The device is backed by a proven safety record
with more than 50,000 devices distributed worldwide and a decade of worldwide
clinical data,” said David Abeyta, Gore Aortic Business Leader. “Now featuring design
enhancements such as a modified stent frame, optimized graft film layers,
enhanced conformability, and expanded oversizing ranges, the Conformable GORE
TAG Device provides an optimal fit and maximum conformability for each
patients anatomy without compromising conformability.”
ABOUT W. L. GORE & ASSOCIATES
The Gore Medical Products Division has provided creative therapeutic solutions
to complex medical problems for more than 35 years. During that time, more than
30 million innovative Gore Medical Devices have been implanted, saving and
improving the quality of lives worldwide. The extensive Gore Medical family of
products includes vascular grafts, endovascular and interventional devices,
surgical meshes for hernia repair, soft tissue reconstruction, staple line
reinforcement and sutures for use in vascular, cardiac and general surgery.
Gore was recently named one of the best companies to work for by Fortune
magazine for the 14th consecutive year. For more information, visit www.goremedical.com.