CE Mark Approval for Abbott Vascular's Xience Prime DES Expanded to Treatment of CLI

January 20, 2011—Abbott Vascular (Santa Clara, CA) announced that it has received CE Mark approval to market its Xience Prime everolimus-eluting coronary stent system for the treatment of critical limb ischemia (CLI) or severe claudication of the lower leg.

Xience Prime is commercially available in countries that recognize CE Mark approval, and the device’s expanded indication for the treatment of CLI or severe claudication of the lower leg applies exclusively in countries where the product bears a CE Mark. The device is available in a broad size matrix, including Xience Prime SV for small vessels and Xience Prime LL for long lesions.

In the United States, Xience Prime is currently an investigational device and is not available for sale, the company advised. 


According to Abbott Vascular, CE Mark approval for Xience Prime to treat CLI or severe claudication of the lower leg is supported by data that were generated from the DESTINY (Drug-Eluting Stents in the Critically Ischemic Lower Leg) trial of the company's Xience V drug-eluting stent.

DESTINY was a 140-patient, investigator-sponsored, randomized, controlled, multicenter trial that compared the Xience V drug-eluting stent to Abbott's Multi-Link Vision bare-metal stent in patients with CLI of the lower leg. Patients with lesion lengths < 40 mm were included in this trial. The 120-month DESTINY data were presented in Germany at the Leipzig Interventional Course that was held January 19–22, 2011. Marc Bosiers, MD, and Dierk Scheinert, MD, served as coprincipal investigators for DESTINY.

The results from DESTINY showed that Xience V had a significantly better patency rate compared to the bare-metal stent at 12 months (85.2 % vs 54.4%; P = .0001). This difference was especially pronounced between 6 and 12 months, when the patency rate for the bare-metal stent fell to nearly 50%, whereas the patency rate for Xience V remained above 85%. These results showed that there is a significant benefit from using an everolimus-eluting stent versus a bare-metal stent, the company stated.