FDA approval for larger diameter, small profile endoprosthesis


W L Gore & Associates (Gore) has announced that it has received approval from the US Food and Drug Administration (FDA) to market a 31mm diameter version of the Gore Excluder abdominal aortic aneurysm endoprosthesis.


The device provides physicians with a safe and effective endovascular option to treat abdominal aortic aneurysms in patients with aortic inner neck diameters up to 29mm.

Other important enhancements include a flat-top design that enables greater production efficiency, an additional pair of proximal anchors to help ensure excellent fixation, and a lengthening of the trunk from seven to eight centimetres to accommodate larger anatomies.

More than 84,000 Excluder devices have been implanted in patients worldwide, making it a widely accepted, minimally-invasive treatment option for individuals with abdominal aneurysm.

The 31mm device will be available for clinical use in the USA in May 2009. It has been available outside of the USA since 2004 and has been implanted in more than 3,300 patients.

“The Gore Excluder endoprosthesis is backed by more than 11 years of commercial data that consistently shows the superior performance of the device,” said David Abeyta, Aortic Business Unit Leader at Gore.

“It has become a leading option for physicians in North America for the treatment of abdominal aortic aneurysm. The unique design of the 31mm device allows physicians to treat patients with a larger range of anatomies, and the fact that it can be implanted using a minimally-invasive procedure means that most patients recover faster and more comfortably.”