Elixir DESyne Drug Eluting Coronary Stent System granted CE Mark approval

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 (Conformité Européenne) for its DESyne Drug Eluting Coronary Stent System for the treatment of coronary artery disease.

“Elixir remains committed to providing clinicians with an innovative and broad product portfolio to advance patient care.”

"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."

"We are pleased with the CE Mark approval of the DESyne stent system. This also validates the effectiveness of Elixir's novel compound Novolimus," said Motasim Sirhan, chief executive officer of Elixir Medical. "Elixir remains committed to providing clinicians with an innovative and broad product portfolio to advance patient care."

Elixir intends to launch the DESyne product platform in the third quarter with a broad size matrix of diameters ranging from 2.5mm to 3.5mm and lengths ranging from 8mm to 28mm.