FDA Approval of the Zenith Fenestrated AAA Endovascular Graft: Will it Transform the EVAR Landscape?

On April 4, 2012, the FDA cleared Cook’s AAA fenestrated stent-graft for commercialization in the U.S. This is a customized design that must be constructed to the anatomical specifications of an individual patient. The adjunctive Zenith Alignment stent was approved as well.

Clinical data support the safety and effectiveness of the device for treatment of juxtarenal and some pararenal aneurysms. Cook Medical plans to release the device gradually at predesignated medical centers beginning later this summer.

The fenestrated stent-graft is an impressive device that adds important technical capabilities for the treatment of AAA patients. The product is costly, though, and the required procedures have proven complex and time-consuming. Wide adoption across the country is not expected any time soon and, in fact, it may not be desirable. It remains unclear (in this writer’s view) what the ultimate impact of the recent approval will be given those limitations, and with the added notion that such aneurysms are relatively uncommon. That said, the commercial availability of the new Cook device represents, unequivocally, an important milestone in the continued quest to provide less-invasive endovascular solutions for AAA disease patients.