THURSDAY, March 24, 2005 (HealthDay News) -- The U.S. Food and Drug Administration has approved a device to treatbulging weak spots in the body's main artery, a condition called anaortic aneurism.
The GORE TAG Endoprosthesis System is designed to make a new pathfor blood flow around the arterial bulge, in order to prevent thethoracic aorta from rupturing, the agency said in a statement.Aneurisms can be caused by vascular disease, injury or an inheriteddefect of the arterial tissue.
The device, made by Arizona-based W.L. Gore and Associates, is agraft made of a Teflon-like substance that re-lines the inside of theweakened aortic wall. Implantation is less invasive than traditionalsurgery to treat aneurisms, the FDA said. Other traditional aneurismtreatments include blood pressure-lowering medications to try toprevent an aortic rupture.
The FDA said it approved the device after its success was provenduring clinical trials involving about 200 people. Study results showedthat aneurism-related deaths were lower in patients who had receivedthe device than among those who hadn't. The agency said it's requiringthe company to monitor the device's effectiveness as it is more widelyused in the general population.
To learn more about aortic aneurisms, visit the Society for Vascular Surgery.