US-based W. L. Gore & Associates has won CE mark approval for new diameter sizes of its Gore Excluder AAA Endoprosthesis endovascular stent-graft, designed to treat abdominal aortic aneurysm (AAA).
The new 23mm and 27mm diameter sizes of the contralateral leg component of the Gore Excluder enables physicians to repair a broader range of anatomies of patients who are eligible for minimally invasive endovascular AAA repair.
Chair of the vascular surgery division at the University of Pittsburgh School of Medicine, Michel Makaroun, said that by adding new diameter options to the Gore Excluder device, patients with large iliac arteries can now be treated with fewer components.
"This will simplify the endovascular aneurysm repair (EVAR) procedure for these patients, widen its applicability and reduce its costs," Makaroun added.
The Gore Excluder stent-graft, which seals off the aneurysm and creates a new path for blood flow, is inserted through a small incision in the patient's leg using a Gore C3 catheter-based delivery system.
The Gore C3 delivery system enables physicians to reposition the stent-graft placed in the diseased aorta and minimises the risk of complications that can occur if the graft needs to be moved after the initial deployment.
The device is characterised by low profile, flexible on and off catheter characteristics, active infrarenal fixation and strong clinical data.
W. L. Gore & Associates business leader, David Abeyta, said: "Gore is committed to providing physicians with innovative solutions that improve patient outcomes."