Gore Receives FDA Advisory Panel Recommendation for Conditional Approval of the TAG Thoracic Endoprosthesis.

FLAGSTAFF, Ariz. -- W. L. Gore & Associates, Inc. (Gore), today announced that its GORE TAG Thoracic Endoprosthesis received conditional approval for marketing clearance by the Circulatory System Devices Panel of the United States Food and Drug Administration (FDA). Gore is now uniquely positioned to provide the first endovascular device to U.S. patients with thoracic aortic aneurysms (TAA), a condition that can lead to rupture of the aneurysm and death.

The FDA Panel's conditional approval paves the way for the GORE TAG Thoracic Endoprosthesis to be used as an alternative to invasive open surgery, a procedure that is often associated with high complication rates such as paraplegia.

Clinical data from the pivotal trial demonstrated that at 30 days the GORE TAG Device patients had one-third the operative mortality, less than one-fourth the paraplegia rates and fewer strokes than the patients in the control group. In addition, there were no aneurysm ruptures in the GORE TAG Device patients through 2 years. Procedural blood loss was 80% less in endovascular surgery vs. traditional open surgery and the GORE TAG Endoprosthesis shortened ICU stays from 3 days to 1 day and hospital stays from 10 to 3 days. TAA patients receiving the GORE TAG Device were able to return to normal activity in less than half the time of those undergoing standard open surgery.

The FDA Advisory Panel meeting featured compelling presentations by R. Scott Mitchell, MD (Stanford University) and Michel S. Makaroun, MD (University of Pittsburgh Medical Center) who were National Principal Investigators for the trial. Their presentations included clinical data comparing the outcomes of the GORE TAG Device to those of open surgical control, as well as discussions about the high morbidity rates associated with open repair of the thoracic aorta. Both physicians were passionate in their remarks to the Panel about the benefits of endovascular treatment.

According to R. Scott Mitchell, MD, in his closing remarks, "Physicians want this device and patients deserve it."

"The results of the study far exceeded my expectations," said Michael Dake, MD. "Without a doubt the GORE TAG Graft has proven to be a safer alternative compared to the surgical procedure."

"The availability of an endovascular treatment option for patients with thoracic aortic aneurysms represents a superior alternative to open surgery in my opinion," said Edward B. Diethrich, MD (Arizona Heart Hospital). "Use of the GORE TAG Thoracic Endoprosthesis in my practice has resulted in significantly decreased morbidity and mortality rates, shorter length of stay and provided patients a shorter return to normal activity as compared to open surgical repair."

And finally, Michel Makaroun, MD, stated, "The approval of the GORE TAG Graft is very good news for physicians and patients in this country."

Thoracic aortic aneurysms reportedly affect over 15,000 people each year. This serious condition is generally believed to be significantly under-diagnosed, because 3 out of every 4 individuals with aneurysms are asymptomatic. Aneurysms occur when a section of the aorta, the body's main circulatory vessel, weakens and bulges outward like a balloon. In the event the aneurysm should rupture, the patient is at high risk for death due to internal bleeding.

TAA treatment has traditionally necessitated highly invasive open surgery. The procedure requires the surgeon to make a large incision in the patient's chest in order to sew a synthetic graft in place. The graft is designed to prevent the aneurysm from rupturing. Open surgical procedures are particularly risky for older patients who may suffer from additional medical conditions such as diabetes or hypertension.

The less invasive endovascular method allows the GORE TAG Device to be inserted through a small incision in the patient's groin. A catheter delivery system is guided into position through the patient's arteries under fluoroscopy. Once in position, a reinforced ePTFE-covered, self-expanding nitinol stent is secured inside the weakened section of the thoracic aorta. The stent-graft excludes the diseased segment from the pressure of blood circulation. Exclusion greatly reduces the risk of a life-threatening rupture. Patients treated with the GORE TAG Device typically experience less trauma than those who undergo open surgery. As a result, recovery time is considerably shorter.

John Sininger, Leader of the Gore Medical Products Division in Flagstaff, Arizona said, "To be the first company to offer a less invasive and safer treatment option is a tremendous accomplishment that underscores Gore's commitment to both the patient and the medical community."

ABOUT W. L. GORE & ASSOCIATES

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for 30 years. During that time, more than 10 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, and sutures for use in vascular, cardiac, general surgery and orthopedic procedures.

GORE and TAG are trademarks of W. L. Gore & Associates.