FDA Approves New Components for Gore's Excluder AAA Device

January 14, 2013—Gore & Associates (Flagstaff, AZ) has received US Food and Drug Administration (FDA) approval for the new large-diameter 35-mm trunk-ipsilateral leg and 36-mm aortic extender components, as well as the lower-profile 31-mm-diameter trunk-ipsilateral leg and 32-mm aortic extender components of the Gore Excluder abdominal aortic aneurysm (AAA) endoprosthesis.

Commenting in Gore's press release, Scott L. Stevens, MD, Professor in the Department of Surgery, University of Tennessee Medical Center, stated, “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 32 mm, providing more patients with access to minimally invasive endovascular treatment options using a superior device.”

According to Gore, the new 35-mm trunk-ipsilateral leg and 36-mm aortic extender are compatible with an 18-F Gore DrySeal sheath for treating infrarenal aortic necks measuring up to 32 mm in diameter, expanding the overall treatment range to 19–32 mm. The lower-profile 31-mm-diameter trunk-ipsilateral leg and 32-mm aortic extender components allow the trunk-ipsilateral leg component to be used with an 18-F Gore DrySeal sheath and the 32-mm aortic extender component to be used with a 17-F compatible sheath to treat aortic necks with an inner diameter of 27–29 mm.

In its press release, the company advised that no changes have been made to the Excluder device itself. Gore has implemented a process using expanded polytetrafluoroethylene materials to constrain the device onto the catheter. This enhancement to the simple delivery of the device reduces the access vessel requirement (6.8 mm) for patients requiring minimally invasive endovascular AAA repair. The 35-mm trunk-ipsilateral leg endoprosthesis and the 31-mm trunk-ipsilateral leg endoprosthesis are only available with the Gore C3 delivery system, stated the company.

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