EU approves Gore's updated Excluder AAA Endoprosthesis
W. L. Gore & Associates (Gore) has received CE Mark for the new lower profile 31 mm diameter trunk-ipsilateral leg and 32 mm aortic extender components of the Gore Excluder AAA Endoprosthesis for treatment of abdominal aortic aneurysms (AAAs).
The reduced profile allows the trunk-ipsilateral leg component to be used with an 18 Fr Gore DrySeal Sheath and allows the 32 mm aortic extender component to be used with a 17 Fr compatible sheath, making the Gore Excluder device one of the lowest profiles for treating aortic necks with an inner diameter of 27 to 29 mm, according to Gore. This update to the delivery of the Gore Excluder device provides a reduced access vessel requirement (6.8 mm) to physicians performing minimally invasive endovascular AAA repair.
No changes have been made to the Gore Excluder device—instead, Gore has implemented a process using ePTFE materials to constrain the device onto the catheter, according to the Flagstaff, Ariz.-based company. In addition, a continued rollout of lower profile Gore Excluder devices is planned.
The Gore Excluder AAA Endoprosthesis is an endovascular stent-graft that seals off the aneurysm and creates a new path for blood flow. Once the physician has positioned the graft in the diseased aorta, the GORE C3 delivery system enables repositioning of the stent-graft.