CE Mark Approval Granted for Elixir's Desyne Novolimus-Eluting Stent

May 23, 2011—Elixir Medical Corporation (Sunnyvale, CA) announced that it has received CE Mark approval for its Desyne novolimus-eluting coronary stent system for treating coronary artery disease. The company stated that novolimus, a metabolite of sirolimus, is a novel macrocyclic lactone compound. Elixir intends to launch the Desyne product platform in the third quarter, with diameters ranging from 2.5 to 3.5 mm and lengths ranging from 8 to 28 mm.

According to Elixir, 9-month clinical, angiographic, and intravascular ultrasound results from the EXCELLA II randomized clinical trial evaluating the Desyne compared to the control Endeavor zotarolimus-eluting coronary stent system (Medtronic, Inc., Minneapolis, MN) demonstrated Desyne's superiority (P < .001) in the study's primary endpoint of in-stent late lumen loss. It also showed statistically significant reductions in neointimal inhibition and restenosis rates. The EXCELLA II results confirmed the 2-year results from the EXCELLA I trial, the company noted.

“The CE Mark approval represents a major accomplishment for the company and validates the impressive clinical results demonstrated with this system,” commented Alexandre Abizaid, MD, Co-principal Investigator for the EXCELLA II clinical trial. “With its thin polymer coating and low drug dose, Elixir's Desyne platform will provide clinicians with technology that raises the bar for the treatment of patients with coronary artery disease.”

Stefan Verheye, MD, added, “The excellent flexibility of the Desyne platform, along with its proven efficacy and safety, make it a versatile workhorse system. This advanced-generation platform will be competitive with the best-in-class systems currently available.”