Xience Prime receives CE mark for treatment of critical limb ischaemia in the lower leg


Abbott announced that it has received CE mark for its Xience Prime everolimus eluting coronary stent system for the treatment of critical limb ischaemia or severe claudication of the lower leg. Data generated on Xience V drug eluting stent from the DESTINY trial supported the stent’s CE mark. DESTINY’s multicentre trial compared the Xience V drug eluting stent to Abbott’s bare metal stent, the Multi-link Vision, in 140 patients with claudication of the lower leg, with lesion lengths less than 40 mm.

“Treating a diseased vessel in the lower leg with an everolimus eluting stent has generated compelling clinical data compared to treatment with a bare metal stent, and we are confident that Xience Prime will become an important option for European physicians treating this critical disease.” said Robert Hance, senior vice president, Vascular, Abbott.


The 12-month results from DESTINY demonstrated that Xience V had significantly better patency compared to the Multi-link Vision bare metal stent at 12 months (85.2% Xience V versus 54.4% Multi-link Vision; p=0.0001). This difference was especially pronounced between six and 12 months, where the difference in patency rate significantly diverged, as the rate for the bare metal stent fell to nearly 50% while the rate for Xience V remained above 85%. These results demonstrated that there is a significant benefit from an everolimus eluting stent versus a bare metal stent. The data from DESTINY were presented at the Leipzig Interventional Course (LINC) held in Leipzig, Germany from 19 to 22 January 2011.


“The DESTINY trial demonstrates that everolimus eluting stents result in significantly better patency at 12 months compared to bare metal stents for patients with critical limb ischaemia of the lower leg, and the use of everolimus eluting stents can potentially provide significantly better outcomes for these patients,” said Marc Bosiers, head of the Department of Vascular Surgery at St. Blasius Hospital in Dendermonde, Belgium, and principal investigator of the DESTINY trial. “A drug eluting stent such as Xience Prime provides European physicians with another treatment option for patients with short lesions in the lower leg.”