Elixir Medical Receives CE Mark Approval for the DESyne BD Novolimus Eluting Coronary Stent System with Biodegradable Polymer Coating

september 4 2012

Elixir Medical Corporation, a developer of product platforms that combine state-of-the-art medical devices with advanced pharmaceuticals, apprised that it has received CE (Conformite Europeenne) Mark approval for its DESyne BD Novolimus Eluting Coronary Stent System for the treatment of coronary artery disease.

“The CE Mark approval validates the impressive clinical results demonstrated with this stent system, including excellent efficacy and no cases of stent thrombosis through the one-year endpoint,” said Alexandre Abizaid, M.D., Ph.D., from the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil, co-principal investigator for the EXCELLA BD clinical trial. “The combined attributes of lowest polymer load, lowest drug dose, and thin stent struts provides physicians with a state-of-the-art workhorse product that raises the bar for treating patients with coronary artery disease.”

The Elixir DESyne BD stent uses a proprietary technology to enable an ultrathin (< 3 microns) polymer coating without the need for an underlying primer layer. The biodegradable, polylactide-based polymer enables the sustained release of Elixir’s novel therapeutic compound, Novolimus, to the coronary vessel wall and degrades within 6-9 months, leaving behind the cobalt chromium alloy metal stent surface to achieve excellent clinical outcomes.

The Elixir DESyne BD Novolimus Eluting Coronary Stent System was evaluated in the EXCELLA BD randomized clinical trial as compared to the control Endeavor Zotarolimus Eluting Coronary Stent System. The study enrolled patients in Europe and Brazil.

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