The Zilver PTX drug-eluting stent (Cook Medical) showed sustained primary patency at two years compared to data collected at one year in the device’s prospective, randomised study, according to data presented at the ISET 2010 International Symposium on Endovascular Therapy, Miami, USA, on 17 January 2011.
The data, compiled from 479 patients enrolled in a randomised controlled trial being conducted to obtain FDA pre-market approval clearance for the device, showed that patients receiving the self-expanding nitinol stent, which is coated with paclitaxel, had 83.1% primary patency after 12 months. When evaluated at 24 months, the patency rate for the 278 patients tested from that cohort was 74.8%.
The two-year results were presented by Michael Dake, the trial’s principal investigator and medical director of the Cath/Angio Laboratories at Stanford University School of Medicine.
Data from the multicentre, prospective trial also show Zilver PTX achieved 86.6% event-free survival at 24 months.
“This clinical trial was rigorously designed to lend real-world perspective to the current treatment landscape of peripheral arterial disease, and we are excited by the results we have thus far collected,” said Rob Lyles, global leader and vice president of Cook Medical’s Peripheral Intervention division. “At Cook, we are committed to delivering technologies that advance minimally invasive healthcare for as wide a patient population as possible.”
The world’s largest study of its kind, the randomised trial is complemented by a global single-arm registry involving 787 patients, including diabetics, symptomatic patients and those with complex lesions. Zilver PTX is an investigational device not approved for sale in the United States.