Elixir Medical has gained CE Mark approval for its DESyne BD Novolimus Eluting Coronary Stent System with biodegradable polymer coating.
The Elixir DESyne BD stent leverages the technology that enables an ultrathin (< 3 microns) polymer coating without the need for an underlying primer layer.
Elixir's novel therapeutic compound, Novolimus, will be released into the coronary vessel wall through the polylactide-based polymer and degrades within six to nine months, leaving behind the cobalt chromium alloy metal stent surface.
Elixir Medical chief executive officer Motasim Sirhan said the CE mark reinforces safety and effectiveness of the DESyne system.
"Elixir remains committed to providing interventional cardiologists with the broadest and most innovative product portfolio to advance patient care. Elixir intends to launch the DESyne BD system in a broad range of sizes," Sirhan added.
The Elixir DESyne BD Novolimus Eluting Coronary Stent System was evaluated in the EXCELLA BD randomized trial as compared to the control Endeavor Zotarolimus eluting coronary stent system.
The Elixir DESyne BD stent demonstrated not only non-inferiority but also superiority over the Endeavor stent for the primary endpoint of in-stent late lumen loss, at six months. The study also reported a statistical difference in favor of DESyne BD for the secondary end point of binary restenosis.