New Device to Treat Descending Thoracic Aneurysms (June 05)

FDA recently approved the first device to prevent ruptures of descending thoracic aneurysms. It's an endovascular graft called the GORE TAG Endoprosthesis System, and it's made by W.L. Gore and Associates.

Descending thoracic aneurysms have traditionally been managed either with anti-hypertensive drugs or by open surgical repair. This GORE TAG graft can provide an alternative to these treatments. Using the device is less invasive than conventional surgery, but it still requires regular follow-up and testing to monitor the success of the treatment over time.

The GORE TAG System consists of an endovascular graft made of expanded polytetrafluoro-ethylene and an outer metal stent. The endovascular graft is delivered by a catheter inserted into the femoral artery in the groin. At the site of the aneurysm, the graft is deployed and then self-expands to the diameter of the aorta, excluding the aneurysm and relining the artery wall. This can prevent further growth and possible rupture of the aneurysm.

FDA approved the device based on review of two clinical studies of 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 the company to conduct additional studies to evaluate its long-term clinical performance and to assure that when the device is used in the large general population, its safety and effectiveness will be comparable to the clinical trials.

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• Device
• Treat
• Descending
• Thoracic
• Aneurysms
• Endovascular
• Graft
• GORE
• TAG
• Endoprosthesis
• System
• FDA
• Anti-Hypertensive
• Drugs