FDA Approves Thoracic Endoprosthesis for Treatment of Descending Thoracic Aorta Aneurysms
Mar 25, 2005 - 8:44:00 AM
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"Today marks the beginning of a new era of less invasive repair of thoracic aortic aneurysms, which will provide a safer alternative to traditional surgery in some patients. Ultimately, the use of this technology may be expanded to manage a variety of challenging aortic diseases with less risk and offers new hope for improved results over current treatment of patients."
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By W. L. Gore & Associates Inc.,
[RxPG] W. L. Gore & Associates Inc. (Gore), has received Food and Drug Administration (FDA) approval to market the GORE TAG Thoracic Endoprosthesis. It is the first device of its kind approved in the United States for treatment of patients with aneurysms of the descending thoracic aorta.
As the only approved device in the United States that provides a minimally invasive alternative to open surgery, the GORE TAG Thoracic Endoprosthesis is anticipated to have a profound impact on the lives of patients with a descending thoracic aortic aneurysm. Observed rates from the GORE TAG Device Pivotal Study demonstrated the GORE TAG Device group had lower operative paraplegia/paraparesis (3% versus 14%), lower operative mortality (1% versus 6%), and significantly less average procedural blood loss (472 mL versus 2,402 mL) as compared to the open surgical control group. Hospital stays were shortened on average from 10 to three days.
The GORE TAG Device group experienced a 66% reduction in aneurysm-related death, and had no aneurysm ruptures through two years. Patients receiving the GORE TAG Device were able to return to normal activity in less time than those undergoing open surgery (30 days versus 78 days).
The first post-FDA approval procedure using the GORE TAG Endoprosthesis was conducted by Michael D. Dake, M.D., at the University of Virginia Health System Hospital in Charlottesville, Va. "A large number of interested U.S. physicians and patients have eagerly awaited the approval and release of the TAG Device," said Dr. Dake. "Today marks the beginning of a new era of less invasive repair of thoracic aortic aneurysms, which will provide a safer alternative to traditional surgery in some patients. Ultimately, the use of this technology may be expanded to manage a variety of challenging aortic diseases with less risk and offers new hope for improved results over current treatment of patients."
John Sininger, leader of the Gore Medical Products Division, said, "The GORE TAG Thoracic Endoprosthesis offers tremendous potential for patients affected with an aortic aneurysm because it prevents an aneurysm from rupturing and reduces the morbidity and mortality associated with open surgery. We feel extremely proud to be the first to the U.S. market with a product that will have such a significant impact on the lives of American patients. This device is a milestone in our company's long history of medical device innovations and accomplishments."
Patients with a thoracic aortic aneurysm are at risk of death due to internal bleeding resulting from a rupture of their aorta. Until now, open surgery requiring an incision large enough to allow a synthetic graft to be sewn in place had been the indicated treatment for this serious condition. The GORE TAG Device can be precisely positioned in the diseased area of the aorta through a small incision made in the patient's groin.
Thoracic aortic aneurysms are diagnosed in approximately 15,000 people annually. This life-threatening condition is generally believed to be significantly underdiagnosed because three out of four individuals with aneurysms are asymptomatic. Aneurysms are a result of a weakening of the thoracic aorta, the body's main circulatory vessel.
Gore Medical Products Division is celebrating 30 years of service to the medical community.
Publication:
United States Food and Drug Administration (FDA)
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Additional information about the news article
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Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for 30 years. During that time, more than 12 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, and surgical mesh for hernia repair.
GORE and TAG are trademarks of W. L. Gore & Associates.
Contacts:
W. L. Gore & Associates Inc.
Customer Service, 800-528-8763
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