Elixir Medical, a medical device company, has gained Conformité Européenne (CE) mark approval for the DESyne BD novolimus eluting coronary stent system to treat coronary artery disease.
The Elixir DESyne BD stent leverages a technology that allows an ultrathin (< 3 microns) biodegradable, polylactide-based polymer coating without using an underlying primer layer.
The Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil, Excella BD trial co-principal investigator Alexandre Abizaid said the CE Mark approval validates the clinical results, including efficacy and no cases of stent thrombosis through the one-year endpoint.
"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," Abizaid said.
Elixir's therapeutic compound, Novolimus, is delivered via the polylactide-based polymer to the coronary vessel wall and degrades within six to nine months, leaving behind the cobalt chromium alloy metal stent surface.
The Elixir DESyne BD novolimus eluting coronary stent system evaluated in the Excella BD trial is compared with the control Endeavor Zotarolimus eluting coronary stent system.
DESyne BD demonstrated superiority over the Endeavor stent for the primary endpoint of in-stent late lumen loss at six months, and there was a statistical difference in favour of DESyne BD for the secondary end point of binary restenosis.
Elixir Medical chief executive officer Motasim Sirhan said the CE Mark approval for the system shows the safety and effectiveness of the device.
"Elixir intends to launch the DESyne BD system in a broad range of sizes," Sirhan said.