Elixir Medical Receives CE Mark for DESyne Novolimus Eluting Coronary Stent System
May 24, 2011 — Elixir Medical Corporation, a developer of product platforms combining state-of-the-art medical devices with advanced pharmaceuticals, announced that it has received CE Mark for its DESyne Drug Eluting Coronary Stent System for the treatment of coronary artery disease.
“The CE Mark approval represents a major accomplishment for the company and validates the impressive clinical results demonstrated with this system,” said Alexandre Abizaid, M.D., Ph.D., from the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil, 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.”
The DESyne stent elutes a novel macrocyclic lactone compound Novolimus. Nine-month clinical, angiographic and IVUS results from the EXCELLA II randomized clinical trial evaluating the Elixir DESyne Novolimus Eluting Coronary Stent System compared to the control Endeavor Zotarolimus Eluting Coronary Stent System demonstrated DESyne superiority (p<0.001) in the study’s primary endpoint of in-stent late lumen loss. Elixir’s DESyne Stent also demonstrated a statistically significant reduction in neointimal inhibition as well as restenosis, a re-blockage of the stent. These EXCELLA II results confirmed the excellent two-year results from the EXCELLA I trial.
“The excellent flexibility of the DESyne platform, along with its proven efficacy and safety, make it a versatile workhorse system,” said Stefan Verheye, M.D., Ph.D. from ZNA Middelheim, Antwerpen, Belgium, the lead enroller in the EXCELLA II clinical trial. "This advanced-generation platform will be competitive with the best-in-class systems currently available."
Elixir intends to launch the DESyne product platform in the third quarter with a broad size matrix of diameters ranging from 2.5 mm to 3.5 mm and lengths ranging from 8 mm to 28 mm.
For more information: http://www.elixirmedical.com
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