Featured Research

from universities, journals, and other organizations

FDA Approves First-of-Kind Device To Treat Descending Thoracic Aneurysms

Date:
April 20, 2005
Source:
U.S. Food And Drug Administration
Summary:
The Food and Drug Administration (FDA) has approved a new device that is intended to prevent ruptures of descending thoracic aneurysms by making a new path for blood flow. The GORE TAG Endoprosthesis System is the first endovascular grafting system approved to treat aneurysms of the thoracic aorta, the main artery that carries blood in the body.

March 23, 2005 -- The Food and Drug Administration (FDA) today approved a new device that is intended to prevent ruptures of descending thoracic aneurysms by making a new path for blood flow. The GORE TAG Endoprosthesis System is the first endovascular grafting system approved to treat aneurysms of the thoracic aorta, the main artery that carries blood in the body.

Related Articles


A thoracic aortic aneurysm is a diseased, weakened, and bulging section of the aorta in the chest. This condition, if not treated, could result in a rupture (bursting) of the aorta, leading to life-threatening internal bleeding. The aneurysm may be caused by vascular disease, injury, or an inherited (genetic) defect of the tissue.

The GORE TAG Endoprosthesis System consists of an endovascular graft made of ePTFE (expanded polytetrafluoroethylene) and a metallic support structure, and a delivery system used to implant the graft. The endovascular graft is delivered by a catheter inserted into the femoral artery in the groin. The graft re-lines the inside of the weakened aortic wall, thus strengthening the vessel and relieving pressure that could cause a rupture. The procedure, while less-invasive, than conventional surgery, does require regular follow-up medical visits and tests to monitor the success of the treatment over time.

Typically, descending thoracic aneurysms are managed either medically with blood pressure-lowering drugs to reduce risk of rupture, or by surgical repair. Large aneurysms are at significant risk of rupture, which often is fatal. Conventional surgical repair requires a major chest operation in which the aneurysm is replaced by a graft. Such surgery is associated with prolonged hospitalization, post-operative monitoring in an intensive care unit, and a recuperation period of three to six months.

FDA approved the Endoprosthesis System based on review of two clinical studies of the System’s safety and effectiveness. These studies involved approximately 200 people. Study results showed that aneurysm-related deaths were lower in patients who had received the endoprosthesis than in the surgical control group.

FDA is requiring that Gore conduct post-approval studies to assure that when the endovascular grafting system is used in the large general population, its safety and effectiveness will be comparable to the clinical trials, and to evaluate the long-term clinical performance of the device.

The GORE TAG Endoprosthesis System is manufactured by W.L. Gore and Associates, Inc. of Flagstaff, Arizona.


Story Source:

The above story is based on materials provided by U.S. Food And Drug Administration. Note: Materials may be edited for content and length.


Cite This Page:

U.S. Food And Drug Administration. "FDA Approves First-of-Kind Device To Treat Descending Thoracic Aneurysms." ScienceDaily. ScienceDaily, 20 April 2005. <www.sciencedaily.com/releases/2005/04/050419112017.htm>.
U.S. Food And Drug Administration. (2005, April 20). FDA Approves First-of-Kind Device To Treat Descending Thoracic Aneurysms. ScienceDaily. Retrieved October 25, 2014 from www.sciencedaily.com/releases/2005/04/050419112017.htm
U.S. Food And Drug Administration. "FDA Approves First-of-Kind Device To Treat Descending Thoracic Aneurysms." ScienceDaily. www.sciencedaily.com/releases/2005/04/050419112017.htm (accessed October 25, 2014).

Share This



More Health & Medicine News

Saturday, October 25, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

IKEA Desk Converts From Standing to Sitting With One Button

IKEA Desk Converts From Standing to Sitting With One Button

Buzz60 (Oct. 24, 2014) IKEA is out with a new convertible desk that can convert from a sitting desk to a standing one with just the push of a button. Jen Markham explains. Video provided by Buzz60
Powered by NewsLook.com
Ebola Protective Suits Being Made in China

Ebola Protective Suits Being Made in China

AFP (Oct. 24, 2014) A factory in China is busy making Ebola protective suits for healthcare workers and others fighting the spread of the virus. Duration: 00:38 Video provided by AFP
Powered by NewsLook.com
WHO: Millions of Ebola Vaccine Doses by 2015

WHO: Millions of Ebola Vaccine Doses by 2015

AP (Oct. 24, 2014) The World Health Organization said on Friday that millions of doses of two experimental Ebola vaccines could be ready for use in 2015 and five more experimental vaccines would start being tested in March. (Oct. 24) Video provided by AP
Powered by NewsLook.com
Doctor in NYC Quarantined With Ebola

Doctor in NYC Quarantined With Ebola

AP (Oct. 24, 2014) An emergency room doctor who recently returned to the city after treating Ebola patients in West Africa has tested positive for the virus. He's quarantined in a hospital. (Oct. 24) Video provided by AP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins