Cook Medical Makes Its Case For Medicare New-Tech Add-On Payments

Article preview from "The Gray Sheet"-  February 20, 2012

 Cook is seeking add-on payments for its Zilver PTX drug-eluting peripheral stent and Zenith AAA endovascular graft in 2013, addressing related CMS questions at a Feb. 14 new-technology “town hall” meeting.

Cook Medical Makes Its Case For Medicare New-Tech Add-On Payments

Article preview from "The Gray Sheet"-  February 20, 2012

Cook Medical Inc. fielded CMS questions regarding two vascular devices for which the firm is seeking Medicare new-technology add-on payments during a Feb. 14 “town hall” meeting at CMS headquarters in Baltimore.

The Medicare agency is weighing evidence in support of add-on payments in fiscal 2013 for Cook’s Zilver PTX drug-eluting peripheral stent to treat symptomatic vascular disease in above-the-knee femoropopliteal arteries, as well as for the firm’s Zenith fenestrated endovascular graft for abdominal aortic aneurysm repair.

Zilver PTX is a self-expanding stent made of nitinol and coated with paclitaxel. During the CMS meeting, Cook outlined the results of its randomized trial comparing Zilver PTX treatment of restenotic lesions of the femoropopliteal artery of up to 14 centimeters in length versus standard-of-care angioplasty and provisional bare-metal stenting.

One-year results showed a 90.4% event-free survival rate, compared to 82.6% in patients randomized to standard angioplasty, and an 83.1% patency rate. At a meeting of FDA’s Circulatory System Devices panel last October, both the panel and FDA agreed that the trial met its primary safety and efficacy endpoints.

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