Cook Medical Inc.’s Zenith fenestrated endovascular graft for abdominal aortic aneurysm repair gained PMA supplement approval April 4. Featuring a bare suprarenal stent at the proximal end of the graft containing 10 or 12 barbs for additional proximal fixation to resist migration, the implant is designed to treat abdominal aortic aneurysms in patients who are anatomically unsuitable for treatment with currently approved AAA endovascular grafts due to a short infra-renal neck. Cook is seeking a Medicare new-technology add-on payment for the Zenith fenestrated graft for 2013. During a Feb. 14 CMS “town hall” meeting, Tara Mastracci, a vascular surgeon at the Cleveland Clinic and a consultant for Cook, said that the endovascular stent graft offers substantial clinical benefit as a repair option for patients with short infra-renal necks who would not have undergone surgery to treat AAA because of severe co-morbidities. (See Also see "Cook Medical Makes Its Case For Medicare New-Tech Add-On Payments" - Medtech Insight, 20 February, 2012..) It will launch later this year.
Cook’s Zenith fenestrated AAA graft is designed to treat abdominal aortic aneurysms in patients who are anatomically unsuitable for treatment with currently approved AAA endovascular grafts due to a short...
