Cook Medical reported that its investigational drug-eluting stent (DES) showed sustained primary patency at two years compared to data collected at one year in the device's prospective, randomized study.
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.