Gore receives FDA approval for new Gore Excluder AAA Endoprosthesis components


Gore has received FDA approval for the new large diameter 35mm trunk-ipsilateral leg and 36mm aortic extender components, as well as the lower profile 31mm diameter trunk-ipsilateral leg and 32mm aortic extender components of the Gore Excluder AAA Endoprosthesis used in the treatment of abdominal aortic aneurysms.

“The expanded sizing options benefit patients and physicians alike. The low profile sheath allows physicians to use the Gore Excluder Device on aortic necks measuring up to 32mm, providing more patients with access to minimally invasive endovascular treatment options using a superior device,” said Scott L Stevens, professor, Department of Surgery, University of Tennessee Medical Center.

The lower profile 31mm diameter trunk-ipsilateral leg and 32mm aortic extender components allow the trunk-ipsilateral leg component to be used with an 18Fr Gore DrySeal Sheath and the 32mm aortic extender component to be used with a 17Fr compatible sheath to treat aortic necks with an inner diameter of 27–29mm.


Accoding to the company, no changes have been made to the Gore Excluder Device itself—instead, Gore has implemented an innovative process using ePTFE materials to constrain the device onto the catheter. This key enhancement to the simple delivery of the device reduces the access vessel requirement (6.8mm) for patients requiring minimally invasive endovascular AAA repair. 


As with all of the lower profile devices, the 35mm trunk-ipsilateral leg endoprosthesis and the 31mm trunk-ipsilateral leg endoprosthesis are only available with the Gore C3 Delivery System.


“While endovascular repair of abdominal aortic aneurysms has proven to be a successful alternative to open surgical repair, physicians continue to seek improvements to the procedures,” said Fred Weaver, professor of Surgery at the Keck School of Medicine of the University of Southern California. “This new lower profile 31mm trunk-ipsilateral leg will expand the treatment options for more patients while continuing to provide flexibility and long-term conformability.”