Elixir Medical has received the CE mark for its DESyne drug-eluting coronary stent system for the treatment of coronary artery disease.
The DESyne stent elutes a macrocyclic lactone compound Novolimus. According to the Sunnyvale, Calif.-based company, the nine-month clinical, angiographic and IVUS results from the EXCELLA II randomized clinical trial evaluating the DESyne novolimus-eluting coronary stent system compared with the control Endeavor zotarolimus eluting coronary stent system (Medtronic) demonstrated DESyne's superiority in the study’s primary endpoint of in-stent late lumen loss. These EXCELLA II results, along with the two-year results from the EXCELLA I trial, were the basis for the approval.
Elixir said that it intends to launch the DESyne product platform in the third quarter of this year with a size matrix of diameters ranging from 2.5 mm to 3.5 mm and lengths ranging from 8 mm to 28 mm.