The data, compiled from 479 patients enrolled in a randomized controlled trial being conducted to obtain US Food and Drug Administration PMA clearance for the device, showed that patients receiving the self-expanding nitinol stent, which is coated with the drug paclitaxel, had 83.1% primary patency after 12 months.
Cook Medical said when the device was evaluated at 24 months, the patency rate for the 278 patients tested from that cohort was 74.8%.
The data from the multicenter, prospective trial also showed that the Cook DES achieved 86.6% event-free survival at 24-months.
Cook Medical Peripheral Intervention division global leader and vice president Rob Lyles said this clinical trial was designed to lend real-world perspective to the current treatment landscape of PAD, and they are excited by the results and they have thus far collected.
